[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"OrsoBio, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,67],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100616021","phase-1-a-study-to-evaluate-single-and-multiple-doses-of-tlc-1180-in-healthy-subjects-100616021",false,"NCT07300189","A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-1180 in Healthy Subjects and an Open-Label Assessment of the Relative Bioavailability of, and Effect of Food on, a Tablet Formulation of TLC-1180","Inclusion Criteria:\n\n* Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive\n* Body mass index from 19 to 35 kg\u002Fm2, inclusive\n* Estimated glomerular filtration rate ≥ 80 mL\u002Fmin\n* Normal liver biochemistry tests\n* Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance\n* Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator\n* Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission\n* Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception\n* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs\n\nExclusion Criteria:\n\n* Pregnant or lactating subjects\n* Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol\n* Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing\n* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody\n* Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen (paracetamol), ibuprofen, and\u002For hormonal contraceptive medications\n* Subjects who have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)\n* Medical history of serious skin disease in the opinion of the investigator, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria\n* Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)\n* Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and\u002For clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction \\\u003C 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years\n* Syncope, palpitations, or unexplained dizziness\n* Implanted defibrillator or pacemaker\n* Medical history of liver disease, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency)\n* History of rhabdomyolysis\n* Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions\n* History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery)\n* Subjects who have received vaccination for COVID-19 within 14 days of Admission\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},288,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.",[28],"Healthy Participants","RECRUITING","2026-04-09",{"date":32,"type":33},"2026-04-14","ACTUAL",{"date":35,"type":33},"2025-10-20",{"date":37,"type":22},"2027-06-01",{"name":39,"class":40},"OrsoBio, Inc","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100502460","phase-1-phase-11b-study-of-tlc-6740-in-healthy-subjects-and-subjects-with-obesity-with-or-without-diabetes-100502460","NCT05822544","Phase 1\u002F1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes","A Phase 1\u002F1b Study of Single and Multiple Ascending Doses of TLC 6740 in Healthy Subjects, Including Evaluation of Food Effect and Potential Drug-Drug Interactions, and Preliminary Safety and Efficacy in Subjects With Obesity, With or Without Diabetes","Inclusion Criteria:\n\n* Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive (Parts A-E); male or female subject between 18 and 70 years of age, inclusive (Parts F, G)\n* Body mass index (BMI) from 19 to 35 kg\u002Fm2, inclusive (Parts A-E); BMI ≥ 30 kg\u002Fm2 and ≤ 50 kg\u002Fm2 (Parts F, G)\n* Estimated glomerular filtration rate (eGFR) ≥ 80 mL\u002Fmin (Parts A-E); eGFR ≥ 60 mL\u002Fmin\u002F1.73m2 or eGFR ≥ 45 mL\u002Fmin\u002F1.73m2, depending on cohort (Parts F, G)\n* ALT\u002FAST\u002FALP ≤ 1 x ULN (Parts A-E); ALT\u002FAST \\\u003C 3 x ULN, ALP \\\u003C 1.5 x ULN (Parts F, G)\n* Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance (Parts A-E)\n* Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator\n* Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission\n* Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception\n* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs\n\nExclusion Criteria:\n\n* Pregnant or lactating subjects\n* Unstable type 2 diabetes (as defined as: HbA1c \\> 10.0%; treatment with insulin and\u002For pioglitazone within 90 days prior to Screening; any history of diabetic ketoacidosis, hyperosmolar state, and\u002For acutely decompensated blood glucose control; hypoglycemia unawareness, hospitalization due to hypoglycemia, or history of severe hypoglycemia \\[requiring outside assistance to regain normal neurologic status\\]) (Part F)\n* History of type 2 diabetes diagnosed prior\n* Medical history of type 1 diabetes or latent autoimmune diabetes of adults (LADA)\n* Obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)\n* Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide (Part G)\n* Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol\n* Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing\n* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody\n* Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)\n* Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and\u002For clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction \\\u003C 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years\n* Syncope, palpitations, or unexplained dizziness\n* Implanted defibrillator or pacemaker\n* Medical history of liver disease, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency)\n* Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions\n* History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery)\n* Subjects who have received vaccination for COVID-19 within 14 days of Admission\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","70 Years",{"count":51,"type":22},564,[25],"The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.",[55,56,57],"Healthy Subjects","Obesity","Type 2 Diabetes","2025-12-10",{"date":60,"type":33},"2025-12-18",{"date":62,"type":33},"2023-04-22",{"date":64,"type":22},"2026-06",{"name":39,"class":40},4,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":66},"100559473","phase-2-phase-2a-study-of-safety-tolerability-and-efficacy-of-tlc-2716-in-subjects-with-hypertriglyceridemia-and-nafld-100559473","NCT06564584","Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD","A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease","Inclusion Criteria:\n\n* BMI ≥ 28 kg\u002Fm2 at Screening\n* Fasting TG ≥ 350 mg\u002FdL\n* Subjects without diabetes or subjects with diabetes and HbA1c \\\u003C 9.5% at Screening\n* Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, platelet count) must fall within the protocol-defined ranges\n* A clinical diagnosis of NAFLD\u002FNASH within 5 years of Screening based on historical hepatic imaging (e.g., ultrasound, MRI, computed tomography \\[CT\\], or Controlled Attenuation Parameter \\[CAP\\] by vibration-controlled transient elastography ≥ 250 dB\u002Fm), and no documented weight loss \\> 5% between the date of the historical hepatic imaging and Screening OR a historical liver biopsy within 5 years of Screening consistent with NAFLD\u002FNASH without cirrhosis and no documented weight loss \\> 5% between the date of the historical liver biopsy and Screening\n* Normotensive subjects or subjects without uncontrolled hypertension, defined as systolic blood pressure \\> 155 mmHg and\u002For diastolic blood pressure \\> 90 mmHg at Screening\n* A 12-lead electrocardiogram (ECG) at Screening that is normal or with abnormalities that are considered not clinically significant by the investigator\n* Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to first dose of study drug\n* Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n\nExclusion Criteria:\n\n* HbA1c ≥ 9.5% at Screening\n* Weight loss \\> 5% during the 90 days prior to Screening\n* Pregnant or lactating subjects.\n* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety\n* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody\n* Medical history of liver disease other than NAFLD\u002FNASH, including but not limited to, alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency.\n* Any history of cirrhosis or decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding, or Child-Pugh-Turcotte score \\> 6 at Screening\n* Unstable cardiovascular disease\n* History of intestinal resection or malabsorptive condition that may limit the absorption of study drug. Appendectomy and cholecystectomy are not exclusionary.\n* Presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at Screening, in the opinion of the investigator\n* Any scheduled surgery during the trial period, excluding minor surgical procedures performed under local anesthesia, in the opinion of the investigator\n* History of malignancy within 5 years prior to Screening except adequately treated carcinoma in situ of the cervix, and\u002For squamous cell cancer, or other localized non-melanoma skin cancer\n* History of significant drug allergy, such as anaphylaxis or significant drug sensitivity, in the opinion of the investigator\n* Known hypersensitivity to study drug, its metabolites, or formulation excipients\n* Presence of any medical condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, including a history of substance abuse or a psychiatric disorder, including any subject with a psychiatric hospital admission or emergency room visit in the 2 years prior to Screening\n* Any laboratory abnormality that in the opinion of the investigator could adversely affect the safety of the subject or impair assessment of study results\n* Medications or therapies prescribed or taken over-the-counter for weight loss, in the 90 days prior to Screening\n* Receipt of vaccination for COVID-19 or any other live vaccine within 14 days of planned dosing of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":75,"type":22},30,[77],"PHASE2","This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.",[80,81],"Hypertriglyceridemia","Nonalcoholic Fatty Liver Disease","2025-03-31",{"date":84,"type":33},"2025-04-03",{"date":86,"type":33},"2024-08-12",{"date":88,"type":22},"2025-09",{"name":39,"class":40},""]