[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MindRank AI Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":172},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,53,81,105,126,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100635280","phase-1-pharmacokinetics-and-safety-of-mdr-001-in-mild-and-moderate-hepatic-impairment-100635280",false,"NCT07550634","Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment","A Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of MDR-001 Tablets in Patients With Mild and Moderate Hepatic Impairment and Matched Participants With Normal Hepatic Function","Inclusion Criteria:\n\n1. Voluntary signed informed consent before any study-related activities, and ability to understand the study procedures and methods, and willingness to strictly comply with the protocol to complete the study.\n2. Participants (including their partners) must have no pregnancy plan and voluntarily take effective contraceptive measures from screening until 6 months after study drug administration.\n3. Age 18 to 70 years (inclusive), male or female.\n4. Male body weight ≥50 kg, female body weight ≥45 kg; body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive).\n5. Estimated glomerular filtration rate (eGFR, calculated by CKD-EPI formula) ≥60 mL\u002Fmin\u002F1.73m².\n6. Additional criteria for participants with hepatic impairment:\n\n   * Chronic liver injury caused by primary liver disease (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.).\n   * Child-Pugh grade A or B (see Appendix 1); recent liver function and complications stable, no significant deterioration (e.g., abdominal pain, increased ascites, nausea, vomiting, anorexia, fever, or worsening of liver-related laboratory results).\n   * Stable medication regimen (including type, dose, or frequency) for the treatment of hepatic impairment, complications, or other concomitant diseases for at least 14 days before study drug administration, with no need for adjustment (diuretics and insulin, etc., excepted); or not taking any such medications.\n\nExclusion Criteria:\n\n1. Allergic constitution, including severe drug allergy or history of drug anaphylaxis; known allergy to the study drug or any of its components.\n2. Screening ECG showing QTcF \\>450 msec (males) or \\>470 msec (females) (Fridericia correction); personal or family history of long QT syndrome; family history (parents, children, siblings) of sudden death before age 40; and\u002For personal history of unexplained syncope within 1 year before screening.\n3. Dysphagia or any gastrointestinal disease affecting drug absorption, including frequent nausea or vomiting from any cause; active peptic ulcer; constipation.\n4. Within 6 months before screening: severe gastrointestinal disease (e.g., active ulcer) or gastrointestinal surgery (except appendectomy, cholecystectomy, or other endoscopic procedures judged not to significantly affect gastrointestinal motility); clinically significant gastric emptying abnormality (e.g., pyloric obstruction, gastroparesis).\n5. Any symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment at screening (except hepatitis B or C); history of serious active infection within 1 month before screening.\n6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or genetic disorders predisposing to medullary thyroid carcinoma.\n7. Blood donation or blood loss ≥400 mL within 3 months before screening, or planned blood donation during the study or within 1 month after study completion.\n8. Use of another investigational drug within 3 months before screening, or planned participation in another clinical study during this study.\n9. Use of CYP3A4 inhibitors\u002Finducers or P-gp inhibitors within 14 days before first dose, or planned use during the study.\n10. Pregnant or breastfeeding women, or positive pregnancy test.\n11. History of depression or other serious mental disorders (e.g., schizophrenia, bipolar disorder, or other severe mood or anxiety disorders); history of suicidal ideation or suicidal behavior.\n12. Any other reason judged by the investigator as unsuitable for enrollment.",true,"ALL","18 Years","70 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and to matched healthy controls. The study aims to evaluate the pharmacokinetics and safety of MDR-001 in these populations. Primary pharmacokinetic endpoints include AUC and Cmax; safety endpoints include adverse events, vital signs, ECG, and laboratory assessments.",[28,29],"Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B)","Hepatic Insufficiency (MeSH ID: D048550)",[31,32,33,34,35,36,37,38,39],"MDR-001","Hepatic impairment (mild, moderate)","Child-Pugh A \u002F Child-Pugh B","GLP-1 receptor agonist (GLP-1RA)","Pharmacokinetics (PK)","safety","Phase I clinical study","Matched healthy controls","Open-label","NOT_YET_RECRUITING","2026-04-19",{"date":43,"type":44},"2026-04-24","ACTUAL",{"date":46,"type":22},"2026-06-01",{"date":48,"type":22},"2026-10-30",{"name":50,"class":51},"MindRank AI Ltd","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":52},"100635279","phase-1-drug-drug-interaction-study-of-mdr-001-with-rifampin-and-itraconazole-in-healthy-adult-participants-100635279","NCT07550621","Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants","A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of MDR-001 and the Effect of Itraconazole on the Pharmacokinetics of MDR-001 in Healthy Adult Study Participants","Inclusion Criteria:\n\n* Voluntary participation and signed informed consent before any study procedures, with full understanding of the study content, procedures, and potential adverse reactions.\n* Healthy Chinese adult males or females aged 18 to 55 years (inclusive).\n* Body weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 18 and 28 kg\u002Fm² (inclusive).\n* Judged by the investigator to be in good health, with medical history, laboratory tests, physical examination, vital signs, and ECG results being normal or abnormal without clinical significance.\n* Participants and their partners must have no pregnancy plan and agree to use effective non-drug contraceptive measures (e.g., condoms, non-medicated intrauterine devices) from 2 weeks before screening until 6 months after the end of the study, unless permanent sterilization has been performed (e.g., bilateral tubal ligation, vasectomy).\n* Willing to comply with the visit schedule, study treatment, laboratory tests, and other study-related procedures and requirements as specified in the protocol.\n\nExclusion Criteria:\n\n* Average daily smoking \\>5 cigarettes within 3 months before dosing.\n* History of headaches (e.g., migraine, tension-type headache).\n* Allergic constitution (multiple drug or food allergies) or intolerance\u002Fallergy to the active ingredient or excipients of the study drugs.\n* History of alcohol abuse (≥14 units of alcohol per week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine).\n* History of drug abuse or use of illicit drugs within 5 years before dosing.\n* Blood donation or significant blood loss (≥400 mL) within 3 months before dosing, or planned blood donation during the study.\n* Any disease that increases bleeding risk, such as acute gastritis or gastric\u002Fduodenal ulcer.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or genetic conditions predisposing to MTC.\n* History of pancreatitis or symptomatic gallbladder disease.\n* Serum calcitonin \\> upper limit of normal (ULN) at screening.\n* Dysphagia, or gastrointestinal disorders affecting absorption (e.g., diarrhea, vomiting, inflammatory bowel disease, active ulcer), or history of gastrointestinal surgery leading to malabsorption, or long-term use of drugs affecting gastrointestinal motility (e.g., bariatric surgery such as gastric banding).\n* Special dietary requirements and unable to accept standardized meals.\n* Surgery within 3 months before dosing, or planned surgery during the study, or surgery that affects drug absorption, distribution, metabolism, or excretion.\n* Received live attenuated vaccine within 1 month before dosing, or planned vaccination during the study.\n* Use of any prescription drug, over-the-counter drug, vitamin product, or herbal medicine within 14 days before dosing.\n* Significant changes in diet or exercise habits within 3 months before dosing.\n* Use of CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inhibitors within 14 days before the first dose, or planned use during the study.\n* Participation in another clinical trial or receipt of an investigational drug within 3 months before dosing (unless the participant withdrew before treatment\u002Frandomization).\n* ECG abnormalities with clinical significance at screening; QTcF \\>450 msec (males) or \\>470 msec (females) by Fridericia's correction.\n* Pregnant, lactating, or positive pregnancy test in females of childbearing potential.\n* Clinically significant laboratory abnormalities, or clinically significant diseases within 12 months before dosing (respiratory, circulatory, digestive, endocrine, rheumatic\u002Fimmune, nervous, hematologic, or psychiatric disorders) that make the participant unsuitable for the study.\n* Positive screening for hepatitis B surface antigen, hepatitis C antibody\u002Fcore antigen, HIV antibody, or syphilis antibody.\n* Acute illness or concomitant medication between screening and first dose.\n* Positive alcohol breath test or urine drug screen.\n* Any other condition judged by the investigator as unsuitable for participation.","55 Years",{"count":62,"type":22},28,[25],"A Phase I, open-label, fixed-sequence, two-part drug-drug interaction study in healthy Chinese adults to evaluate the effect of multiple-dose rifampin (Part A) or itraconazole (Part B) on the single-dose pharmacokinetics of MDR-001, an oral GLP-1 receptor agonist.",[66],"Healthy Volunteers (HV)",[31,68,69,70,71,72,73,35,74],"GLP-1 receptor agonist","Drug-drug interaction (DDI)","Rifampin","Itraconazole","CYP3A4 inducer","CYP3A4 inhibitor","Healthy volunteers",{"date":43,"type":44},{"date":77,"type":22},"2026-05-06",{"date":79,"type":22},"2026-06-08",{"name":50,"class":51},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100614018","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-mdr-001-in-adult-participants-with-overweight-or-obesity-mobile-100614018","NCT07274137","A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of MDR-001 Administered Orally Over 52 Weeks in Participants With Overweight or Obesity (MOBILE)","Inclusion Criteria:\n\n* Have given written informed consent to participate in this study\n* Chinese male or female participants who are aged 18-65 (inclusive) years at the time of signing the ICF\n* Participants who are obesity (BMI ≥ 28.0 kg\u002Fm2), or overweight (24.0 kg\u002Fm2 ≤ BMI \\\u003C 28.0 kg\u002Fm2) with at least one of the the following weight-related comorbidities at screening:1) Pre-diabetes. 2) Hypertension.3) Dyslipidemia.4) Fatty liver.5) Obstructive sleep apnea syndrome.6) Complaint of weight-bearing joint pain.\n* Participants had a stable weight maintenance during the 3 months of dietary and physical activity prior to screening (participant-reported data acceptable) and no more than 5% weight fluctuation\n\nExclusion Criteria:\n\n* Obesity induced by secondary diseases or drug\n* Have diabetes mellitus\n* Have any lifetime history of a suicidal attempt or suicidal behavior\n* Have a history of depressive disorder\n* History of gout within 6 months prior to screening\n* History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:1)Acute myocardial infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), heart valve repair\u002Freplacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack \\[TIA\\]).2)Congestive heart failure of New York Heart Association (NYHA) class III or IV.3)Severe arrhythmias\n* History of malignancy within 5 years prior to screening or newly diagnosed malignancy at screening\n* Have a family or personal history (parents, children, and siblings of medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2 .\n* Abnormal thyroid function tests at screening not adequately controlled by stable medication doses , or thyroid ultrasound at screening showing thyroid nodules classified as Chinese-thyroid imaging-reporting and data system category 4 or higher.\n* History of significant gastrointestinal disease or gastrointestinal surgery or clinically significant gastric emptying abnormality within 6 months prior to screening.\n* History of intestinal disorders deemed clinically significant by the investigator, or acute hemorrhoidal episode within 3 months prior to screening.\n* History of acute or chronic pancreatitis, or abnormally elevated serum amylase or lipase levels at screening.\n* revious acute or chronic hepatitis, or symptoms and signs of any other liver disease other than non-alcoholic fatty liver disease, or abnormalities in related laboratory tests at screening\n* Presence of acute or chronic cholecystitis at screening, or symptomatic or treatment-requiring cholelithiasis\u002Fgallbladder polyps at screening, or newly diagnosed cholelithiasis within 6 months before screening\n* Hypersensitivity or suspected hypersensitivity to glucagon-like peptide 1 receptor agonist (GLP-1RA) drugs or excipients.\n* History of drug abuse or dependence prior to screening.\n* Have current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including but not limited to:\n\n  1. Approved\u002Funapproved marketed weight-loss drugs: orlistat, sibutramine hydrochloride, phentermine, phentermine-topiramate, naltrexone-amfebutamone, tirzepatide, semaglutide, liraglutide, beinaglutide, phendimetrazine, methylamphetamine, etc.\n  2. Investigational products of weight-loss: Glucagon-like peptide 1 receptor (GLP-1R) agonists, GLP-1R\u002Fglucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)\u002FGLP-1R agonists, GIPR\u002FGLP-1R\u002FGCGR agonists,GLP-1R agonists\u002Factivin type II receptor (ActRII) inhibitors, GLP-1R\u002FGIPR\u002Ffibroblast growth factor 21 receptor (FGF21R) agonists or FGF21R\u002FGCGR\u002FGLP-1R agonists.\n  3. Hypoglycemic drugs, such as metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZDs) or dipeptidyl peptidase 4 (DPP-4) inhibitors.\n  4. Systemic steroid therapy (including intravenous, oral, intra-articular).\n  5. Tricyclic antidepressants or other antipsychotic or antiepileptic drugs affecting body weight (e.g., mirtazapine, paroxetine, clozapine, olanzapine, risperidone, quetiapine, paliperidone, valproic acid, valproic acid derivatives, lithium).\n* History of bariatric surgery (excluding acupuncture\u002Fcupping\u002Fcatgut embedding for bariatric surgery, liposuction, and abdominoplasty performed \\>1 year prior to screening) or plans to undergo bariatric surgery or acupuncture\u002Fcupping\u002Fcatgut embedding, liposuction, abdominoplasty during the study period.\n* Planned chronic use of medications affecting gastrointestinal motility or scheduled gastric emptying-impairing surgery during the study period.\n* Major or medium-sized surgery, or severe trauma or serious infection within 3 months prior to screening, which, as assessed by the investigator, would preclude trial participation, or planned surgery during the study period (excluding outpatient procedures deemed by the investigator to have no impact on subject safety or trial outcomes).\n* History of organ transplant.\n* Use of any drug or food known to potently or moderately inhibit or induce cytochrome P450 3A4 enzyme (CYP3A4) and\u002For inhibit P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study.\n* Currently participating in any other clinical study, or if received any investigational product or medical devices within ≤ 3 months or 5 half-lives (t1\u002F2) prior to screening, whichever is longer.\n* Donation or loss of ≥ 400 mL of blood or transfusion\u002Fblood products during this period within 3 months prior to screening, or intention to donate blood during the study.\n* emale participants during pregnancy or lactation.\n* The investigator, site personnel, and\u002For their immediate family members directly related to the study. An immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n* Participants who may be unable to complete this study for other reasons, or have other conditions that, as assessed by the investigator, will make the participant unsuitable for participation in this study, for example, the participant refuses to use only the weight-loss drugs specified in the protocol during the study.","65 Years",{"count":90,"type":22},738,[92],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy and safety of the oral small molecule MDR-001 Tablets over 52 weeks as an adjunct to a lifestyle intervention in participants with overweight or obesity.The goal of this clinical trial is to determine whether the oral drug MDR-001 can improve weight management in adult participants with overweight or obesity.",[95],"Overweight or Obesity","2025-12-15",{"date":98,"type":44},"2025-12-22",{"date":100,"type":22},"2026-02",{"date":102,"type":22},"2027-07",{"name":50,"class":51},45,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":52},"100601459","phase-1-phase-ib-clinical-study-on-the-efficacy-and-safety-of-mdr-001-in-patients-who-are-obesity-or-overweight-100601459","NCT07110766","Phase Ib Clinical Study on the Efficacy and Safety of MDR-001 in Patients Who Are Obesity or Overweight","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ib Clinical Study to Evaluate the Efficacy and Safety of Small Molecule MDR-001 Tablets Administered Orally for 12 Weeks Treatment in Overweight or Obesity Participants","Inclusion Criteria:\n\n* Have given written informed consent to participate in this study.\n* Chinese male or female participants who are aged 18-65 (inclusive) years at the time of signing the ICF.\n* Participants who are obesity (BMI ≥ 28.0 kg\u002Fm2), or overweight (24.0 kg\u002Fm2 ≤ BMI \\\u003C 28.0 kg\u002Fm2) with at least one of the following weight-related comorbidities at screening:\n\n  1. Pre-diabetes: 6.1 mmol\u002FL (110 mg\u002FdL) ≤ FPG \\\u003C 7.0 mmol\u002FL (126 mg\u002FdL), and\u002For 5.7% ≤ HbA1c \\\u003C 6.5%.\n  2. Hypertension: Medically documented history of hypertension, or newly diagnosis of hypertension at screening (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg, measured at least 3 times on different days).\n  3. Dyslipidemia: Medically documented history of dyslipidemia (with or without medication), or at screening TC ≥ 5.2 mmol\u002FL (200 mg\u002Fdl), and\u002For LDL-C ≥ 3.4 mmol\u002FL (130 mg\u002Fdl), and\u002For HDL-C \\\u003C 1.0 mmol\u002FL (40 mg\u002Fdl), and\u002For TG ≥ 1.7 mmol\u002FL (150 mg\u002Fdl).\n  4. Fatty liver disease: Evidence of fatty liver confirmed by imaging within 3 months prior to screening or newly diagnosed at screening.\n  5. Obstructive sleep apnea syndrome.\n  6. Complaint of weight-bearing joint pain (during or within 3 months prior to screening).\n* Participants had a stable weight maintenance during the 3 months of dietary and physical activity prior to screening (participant-reported data acceptable) and no more than 5% weight fluctuation, which is calculated as: (maximum weight - minimum weight during the 3 months of dietary and exercise control prior to screening)\u002Fmaximum weight \\*100%.\n* Female participants of childbearing potential (including female partners of male participants) who have no plans to father a child or donate sperm from screening until 6 months after the last dose, and are willing to use at least one effective contraception.\n* Participants who well understand the study objectives, can communicate well with the investigator and to understand and comply with the requirements of this study, such as following the protocol medication and lifestyle intervention.\n\nExclusion Criteria:\n\n* Obesity secondary to underlying medical conditions or drug therapy, including but not limited to hypercortisolism (e.g., Cushing's syndrome), polycystic ovary syndrome, or obesity due to pituitary\u002Fhypothalamic damage; OR weight increase attributable to elevated non-fat mass (e.g., edema) at screening or randomization.\n* Have diabetes mellitus (including type 1 diabetes, type 2 diabetes, diabetes secondary to pancreatic injury, or other types of diabetes) or diagnosed with type 2 diabetes at screening\u002Frandomization, defined as HbA1c ≥ 6.5%, and\u002For fasting plasma glucose ≥ 7.0 mmol\u002FL (126 mg\u002FdL), and\u002For random plasma glucose ≥ 11.1 mmol\u002FL (200 mg\u002FdL).\n* One or more episodes of unexplained hypoglycemic events within 3 months prior to screening, defined as FPG \\\u003C 2.8 mmol\u002FL (50 mg\u002FdL) and\u002For presence of clinically significant hypoglycemic symptoms (symptoms of sympathetic activation \\[e.g., palpitations, anxiety, sweating, dizziness, hand tremble, hunger, etc.\\] and neuroglycopenic symptoms \\[e.g., altered consciousness, cognitive impairment, convulsions, and coma\\]).\n* History of psychiatric disorders, addictive disorders, or other conditions that may compromise the subject's ability to provide informed consent; OR history of unstable anxiety and\u002For depression that, in the investigator's judgment, remains clinically significant.\n* Have any lifetime history of a suicidal attempt or suicidal behavior.\n* History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:\n\n  1. Acute myocardial infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), heart valve repair\u002Freplacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack \\[TIA\\]).\n  2. Congestive heart failure of New York Heart Association (NYHA) class III or IV.\n* History of cardiac arrhythmias, including torsades de pointes, ventricular tachycardia, or second- or third-degree atrioventricular block.\n* Have a family or personal history of long QT syndrome, or family history of sudden death in first-degree relatives (parent, child, sibling) before the age of 40 years, and\u002For personal history of unexplained syncope within 1 year prior to screening.\n* History of gout within 6 months prior to screening.\n* History of proliferative retinal disease or maculopathy.\n* History of malignancy within 5 years prior to screening (except cured basal cell carcinoma of skin and cervical carcinoma in situ) or newly diagnosed malignancy at screening.\n* Have a family or personal history (parents, children, and siblings) of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2).\n* Abnormal thyroid function tests at screening (thyroid-stimulating hormone \\[TSH\\] \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL) not adequately controlled by stable medication doses (defined as stable dosage for ≥3 months), untreated subclinical hypothyroidism (TSH \\\u003C10.0 mIU\u002FL with normal free T3 \\[FT3\\] and free T4 \\[FT4\\] levels) is permitted.\n* History of significant gastrointestinal disease (e.g., active ulcer) or gastrointestinal surgery (except appendectomy, cholecystectomy, or other gastrointestinal endoscopic procedures judged by the investigator as having no significant effect on gastrointestinal motility) or clinically significant gastric emptying abnormality (e.g., pyloric obstruction, gastroparesis) within 6 months prior to screening.\n* History of gastrointestinal disorders (e.g., chronic diarrhea, constipation, hemorrhoidal bleeding-whether resolved or not) deemed clinically significant by the investigator, OR acute exacerbation of hemorrhoids within 3 months prior to screening.\n* History of acute or chronic pancreatitis, or serum amylase or lipase \\> 1.5 × upper limit of normal (ULN) at screening.\n* Previous acute or chronic hepatitis, or symptoms and signs of any other liver disease other than non-alcoholic fatty liver disease, or any of the following, as determined by laboratory tests at screening:\n\n  1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN.\n  2. Blood total bilirubin (TBIL) ≥ 1.5 × ULN.\n  3. Alkaline phosphatase (ALP) ≥ 3 × ULN.\n* Symptomatic cholecystitis or biliary diseases within 1 year prior to screening, except those with documented resolution of biliary stones following treatment.\n* Hypersensitivity or suspected hypersensitivity to glucagon-like peptide 1 receptor agonist (GLP-1RA) drugs or excipients.\n* History of drug abuse or dependence prior to screening.\n* High alcohol consumption within 3 months prior to screening (defined as an average daily consumption of more than 25 g of pure alcohol \\[equivalent to 750 mL of beer or 250 mL of wine or 50 g of liquor\\]).\n* Have current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including but not limited to:\n\n  1. Approved\u002Funapproved marketed weight-loss drugs: orlistat, sibutramine hydrochloride, phentermine, phentermine-topiramate, naltrexone-amfebutamone, tirzepatide, semaglutide, liraglutide, beinaglutide, phendimetrazine, methylamphetamine, etc.\n  2. Glucagon-like peptide 1 receptor (GLP-1R) agonists or GLP-1R\u002Fglucagon receptor (GCGR) agonists or glucose-dependent insulinotropic polypeptide receptor (GIPR)\u002FGLP-1R agonists or GIPR\u002FGLP-1R\u002FGCGR agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors.\n* History of bariatric surgery (excluding acupuncture\u002Fcupping\u002Fcatgut embedding for bariatric surgery, liposuction, and abdominoplasty performed \\>1 year prior to screening) or plans to undergo bariatric surgery or acupuncture\u002Fcupping\u002Fcatgut embedding, liposuction, abdominoplasty during the study period.\n* Symptomatic cholecystitis or biliary diseases within 1 year prior to screening, except those with documented resolution of biliary stones following treatment.\n* Major or medium-sized surgery, or severe trauma or serious infection within 3 months prior to screening, which, as assessed by the investigator, would preclude trial participation, or planned surgery during the study period (excluding outpatient procedures deemed by the investigator to have no impact on subject safety or trial outcomes).\n* History of organ transplant.\n* Use of any drug or food known to potently or moderately inhibit or induce cytochrome P450 3A4 enzyme (CYP3A4) and\u002For inhibit P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study.\n* Uncontrolled hypertension at screening, defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg (verified prior to randomization. Blood pressure measurement should be performed after ≥5 minutes of seated rest, initial measurement followed by a second measurement after ≥1 minute, the final value will be the arithmetic mean of the two measurements (rounded to the nearest integer). If the difference between the first two measurements is ≥5 mmHg for either SBP or DBP, a third measurement shall be taken after ≥1 minute, the final value will be the arithmetic mean of all three measurements (rounded to the nearest integer).\n* Positive hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody at screening.\n* If any of the following laboratory abnormalities are present at screening:\n\n  1. Blood calcitonin ≥ 50 ng\u002FL.\n  2. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73 m2, calculated according to the CKD-EPI formula, as shown in Appendix VIII.\n  3. Poorly controlled severe dyslipidemia with TG ≥ 5.65 mmol\u002FL (500 mg\u002FdL) despite the use of conventional lipid-lowering drugs.\n  4. Prothrombin time-international normalized ratio (INR) \\> 1.5 × ULN.\n  5. Hemoglobin \\\u003C 110 g\u002FL (female) or \\\u003C 120 g\u002FL (male).\n* QTcF \\> 450 ms for male or QTcF \\> 470 ms for female at screening, measured after rest at least 5 min (repeat the measurement once and take the mean value \\[rounded off to integer\\]; the interval between measurements is 2 min±60 s).\n* Currently participating in any other clinical study, or if received any investigational product or medical devices within ≤ 3 months or 5 half-lives (t1\u002F2) prior to screening, whichever is longer.\n* Donation or loss of ≥ 400 mL of blood or transfusion within 3 months prior to screening.\n* Female participants during pregnancy or lactation.\n* The investigator, site personnel, and\u002For their immediate family members directly related to the study. An immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n* Participants who may be unable to complete this study for other reasons, or have other conditions that, as assessed by the investigator, will make the participant unsuitable for participation in this study, for example, the participant refuses to use only the weight-loss drugs specified in the protocol during the study.",{"count":113,"type":22},24,[25],"This is a 12 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase Ib trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.",[117],"Obesity &Amp; Overweight","2025-07-31",{"date":120,"type":44},"2025-08-08",{"date":122,"type":22},"2025-08-09",{"date":124,"type":22},"2025-10-30",{"name":50,"class":51},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":52},"100575943","phase-1-a-phase-iiia-clinical-study-to-assess-the-single-and-multiple-ascending-doses-of-mdr-001-tablets-in-healthy-participants-and-obese-overweight-participants-100575943","NCT06778850","A Phase I\u002FIIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese\u002F Overweight Participants","A Randomized, Double-blind, Placebo-controlled Phase I\u002FIIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese\u002F Overweight Participants","Inclusion Criteria:\n\n* Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.\n* Participants with 27 ≤ body mass index (BMI) ≤ 45 kg\u002Fm2.\n* For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.\n\nExclusion Criteria:\n\n* Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.\n* Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.\n* Participants with a history of pancreatitis or symptomatic gallbladder disease.\n* Serum calcitonin \\> ULN at screening.\n* Participants with systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg at screening.\n* Participants with ALT \\>2 × ULN and \u002For AST \\> 2 × ULN at screening.\n* Participants whose fasting triglycerides \\> 5.7 mmol\u002FL, total cholesterol \\> 7.75 mmol\u002FL, low-density lipoprotein cholesterol \\> 4.9 mmol\u002FL at screening.\n* Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).\n* Participants with fasting blood glucose levels \\> 7 mmol\u002FL.\n* Participants with creatinine clearance \\\u003C 60 mL\u002Fmin at screening \\[calculation formula: CLcr: (140 - age) × weight (kg) \u002F \\[72 × 0.0113 × Scr (μmol\u002FL)\\], × 0.85 for females\\].\n* Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.\n* Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \\> 450 ms for male participants or \\> 470 ms for female participants.",{"count":134,"type":22},131,[25,136],"PHASE2","To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese\u002F overweight participants.",[139],"Overweight and Obese Volunteers","RECRUITING","2025-03-05",{"date":143,"type":44},"2025-03-07",{"date":145,"type":44},"2023-06-09",{"date":147,"type":22},"2025-12-30",{"name":50,"class":51},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100562693","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-mdr-001-in-subjects-who-are-obesity-or-overweight-100562693","NCT06606483","A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight","A 24 Weeks, Multicenter, Randomized, Double-blind, Placebo, Parallel-controlled Phase IIb Trail Comparing the Efficacy and Safety of MDR-001 Tablet Versus Placebo in Subjects With Overweight or Obesity","Inclusion Criteria:\n\n1. In accordance with adequate informed consent, the subject voluntarily signs the Informed Consent Form (ICF).\n2. Male or female participants aged ≥18 and ≤ 65 years, who have signed the Informed Consent Form (ICF)\n3. Have BMI of\n\n   • obesity: ≥28 kg\u002Fm2\n   * overweight: ≥24 kg\u002Fm2 and ≤28 kg\u002Fm2 with at least 1 of the following weight-related comorbidities\n\n     1\\) prediabetes: 6.1 mmol\u002FL (110 mg\u002FdL) ≤FPG≤7.0 mmol\u002FL (126 mg\u002FdL) ; and\u002For 5.7%≤HbA1c≤6.5% 2）Hypertension: medical record for Hypertension, or diagnosis of hypertension for the first time during screening (with at least three measurements spaced across at least over a period of two days, defining hypertension as a systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg).\n\n     3\\) Dyslipidemia: medical record for dyslipidemia (regardless of medication treatment) or TC≥5.2 mmol\u002FL (200 mg\u002Fdl), and\u002For LDL-C≥3.4 mmol\u002FL (130 mg\u002Fdl), and\u002For HDL-C\\\u003C1.0 mmol\u002FL (40 mg\u002Fd l), and\u002For TG≥1.7 mmol\u002FL (150 mg\u002Fdl) at screening 4) fatty liver disease(FLD): Presence of FLD confirmed by imaging studies within three months prior to screening, or diagnosis of FLD at screening 5) obstructive sleep apnea 6) Presence of weight-bearing joint pain during the screening period or within three months prior to screening. (Acceptance of patient self-description)\n4. The weight change achieved through dietary and exercise control should not exceed a 5% variation within three months prior to screening. (Acceptance of patient self-description)\n5. Potential participants with fertility potential (including the partners of male participants) must not have any plans for conception or sperm donation from the screening period until 6 months after the last dose administration, and they should be willing to use at least one effective contraception method.\n6. The participant must have a thorough understanding of the trial objectives, be able to communicate effectively with the investigators, and be capable of comprehending and adhering to all the requirements of this trial, including following the medication regimen and lifestyle guidance as outlined in the protocol.\n\nExclusion Criteria:\n\n1. Have obesity induced by other disorders or drugs, including elevated cortisol hormones (such as Cushing's syndrome), polycystic ovary syndrome, obesity due to pituitary and hypothalamic injuries, etc\n2. Previous diagnosis of diabetes mellitus (including Type 1 diabetes, Type 2 diabetes, diabetes caused by pancreatic injury, or other types of diabetes) or diagnosis of Type 2 diabetes at the time of screening\u002Frandomization, defined as: HbA1c ≥ 6.5%; and\u002For fasting plasma glucose ≥ 7.0 mmol\u002FL (126 mg\u002FdL); and\u002For random plasma glucose ≥ 11.1 mmol\u002FL (200 mg\u002FdL).\n3. A history of at least one episode of hypoglycemia occurring within the 3 months prior to screening, without apparent precipitating causes, is defined as FPG \\<2.8 mmol\u002FL (50 mg\u002FdL) and\u002For the presence of marked symptoms of hypoglycemia.\n4. A history of psychiatric disorders, addictive diseases, or other conditions that may impair the ability of the participant to provide informed consent.\n5. A history of suicidal ideation or suicidal behavior.\n6. Have any of the following major cardiovascular and cerebrovascular conditions within 6 months prior to Screening 1) myocardial infarction(MI), percutaneous coronary intervention(PCI), coronary artery bypass grafting(CABG), heart valve repair\u002Freplacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack (TIA)); 2) New York Heart Association Functional Classification III or IV congestive heart failure\n7. A history of gout within the past six months prior to screening.\n8. A history of proliferative retinopathy or macular degeneration.\n9. Have a history of malignancy less than 5 years or diagnosis of malignancy at screening (other than cured basal cell skin cancer, or in situ carcinomas of the cervix)\n10. Have a known self or family history (first-degree relative) of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n11. Have a personal or family history of long QT syndrome, family history of sudden death in a first-degree relative (parents, siblings, or children) before the age of 40 years, and\u002For a personal history of unexplained syncope within the last year.\n12. During the screening phase, subjects exhibited thyroid function abnormalities uncontrolled (TSH\\>6 mIU\u002FL or \\<0.4 mIU\u002FL) by a stable medication regimen (stable dosages for three months or more), Subclinical hypothyroidism requiring no treatment (with TSH levels \\<10.0 mIU\u002FL and normal range of FT3 and FT4) is excluded.\n13. Within the six months preceding screening, subjects experienced severe gastrointestinal disorders (such as active gastric ulcers), or underwent gastrointestinal surgery (Appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility are excluded), or have a known clinically significant gastric emptying abnormality (for example, pyloric obstruction, gastroparesis)\n14. Amylase\u002Flipase\\>3 ULN at screening or have had a history of chronic or acute pancreatitis\n15. Have had a history of chronic or acute hepatitis; or have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease at screening, or any of the following, as determined by the laboratory during screening 1）ALT or AST ≥3×ULN 2）TBIL≥1.5×ULN 3）ALP≥3×ULN\n16. Subjects with a history of acute biliary tract disease (cholecystitis, gallstones, or bile duct stones) within one year prior to screening, or suffer from biliary tract disease accompanied by related clinical symptoms which should be treated at screening\u002Frandomization, are deemed unsuitable for participation in this clinical trial by the investigator.\n17. The subjects exhibit hypersensitivity or a suspected hypersensitivity to GLP-1 receptor agonists (GLP-1RAs) or to excipients.\n18. Have a history of drug or alcohol abuse\n19. Have a history of alcoholism within the prior 3 months of study screening (750 mL of beer or 250 mL of wine or 50 g of distilled spirits per day)\n20. Have taken within 3 months prior to screening medications or food intended to affect body weight, including but not limited to:\n\n1\\) Approved\u002Funapproved weight-loss drugs: Orlistat, Sibutramine Hydrochloride, Phentermine Resin Complex, Phentermine-Topiramate, Contrave, Semaglutide, Liraglutide, Phendimetrazine, Methamphetamine, etc.; 2) GLP-1RA or GLP-1R\u002FGCGR or GIPR\u002FGLP-1R or GIPR\u002FGLP-1R\u002FGCGR or DPP-4 inhibitors 3) Hypoglycemic drugs, such as metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZDs), etc.\n\n4\\) Systemic steroids (including intravenous, oral, intra-articular administration) 5) Tricyclic antidepressants or other antipsychotic or antiepileptic drugs intended to affect body weight (such as: Mirtazapine, Paroxetine, Clozapine, Olanzapine, Risperidone, Paliperidone, Valproic acid, Valproic acid derivatives, lithium salt).\n\n21\\. Have a prior or planned surgical treatment for obesity (excluding acupuncture, cupping, thread lift, liposuction or abdominoplasty, if performed 1 year prior to screening) or planned surgical treatment or acupuncture, cupping, thread lift, liposuction or abdominoplasty during clinical trial 22. Screening within 3 months before the large or medium-sized surgery or serious trauma, severe infection occurred, the investigator judged not suitable for this trial or during the trial period is planned to receive surgery (Outpatient surgeries that are judged by the investigator to have no impact on the safety of the subjects and the results of the trial are excluded) 23. Have had a history of organ transplantation 24. The use of any drugs or foods known to potently or moderately inhibit CYP3A4 and\u002For P-gp is prohibited within 28 days prior to the first administration of the study drug and throughout the duration of the trial.\n\n25\\. Have poorly controlled hypertension (mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥100 mm Hg) at screening (Pre-randomization review; seated, at rest for at least 5 minutes, with a second measurement taken to average the values if the difference between the two measurements exceeds ≥5 mmHg, with a third measurement taken if necessary, with at least a one-minute interval between each test. The final test result is the arithmetic mean of the three test results) 26. positive HBsAg or HCV antibodies or HIV antibodies or syphilis antibodies at screening 27. During the screening phase, laboratory examination results meet any of the following criteria:\n\n1. calcitonin≥50 ng\u002FL\n2. estimated eGFR ≤60 mL\u002Fmin\u002F1.73 m2, calculated by CKD-EPI\n3. uncontrolled severe dyslipidemia, with triglyceride (TG) levels ≥ 5.65 mmol\u002FL (500 mg\u002FdL) treated by conventional lipid-lowering medications.\n4. INR\\>1.5×ULN\n5. hemoglobin value \\<110 g\u002FL (females) or \\<120 g\u002FL (males) 28. Screening for QTcF\\>450 ms (males) and QTcF\\>470 ms (females) at rest (at least 5 min, repeat measurement once to obtain the average, with a 2 min ± 60 s interval between the two measurements).\n\n29\\. Participating in another clinical trial; or, if on treatment with the investigational drug or device, the time since the last dose or cessation of treatment is ≤3 months or 5 half-lives (t1\u002F2) of the investigational drug (whichever is longer) prior to the first day of this trial screening.\n\n30\\. Have a blood transfusion or severe blood loss ≥500 mL within the prior 3 months of study screening or received blood transfusion before screening 31. Pregnant or lactating females; 32. Parties directly associated with this trial, including but not limited to, the principal investigator(s), staff members of the trial centers, and\u002For their immediate family members. Immediate family members are defined as spouses, parents, children, or siblings, whether born or legally adopted.\n\n33\\. Inability to complete the trial for reasons unrelated to the study, or any other condition or prior therapy that would make the participant unsuitable for this study (such as participant refusal to adhere to the prescribed weight-loss medication exclusively during the trial period).",{"count":157,"type":22},300,[136],"This is a 24 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase IIb trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.",[161,162],"Obesity","Overweight and Obesity","2024-09-22",{"date":165,"type":44},"2024-09-24",{"date":167,"type":22},"2024-09-23",{"date":169,"type":22},"2025-09-30",{"name":50,"class":51},19,""]