[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502460":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":58,"centralContacts":62,"locations":68,"responsibleParty":99,"collaborators":34,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":34,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":34,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":34,"overallStatus":71,"whyStopped":34,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"OrsoBio, Inc","INDUSTRY",[8,15,21,26,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Solution","EXPERIMENTAL","Oral solution of TLC-6740",[13,14],"Drug: TLC-6740 Oral Solution","Other: Placebo Oral Solution",{"label":16,"type":10,"description":17,"interventionNames":18},"Tablet","Tablet formulation of TLC-6740",[19,20],"Drug: TLC-6740 Tablet","Other: Placebo Tablet",{"label":22,"type":10,"description":23,"interventionNames":24},"Drug Metabolizing Enzyme","Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin",[19,25],"Drug: Drug Metabolizing Enzyme",{"label":27,"type":10,"description":28,"interventionNames":29},"TLC-6740 + Tirzepatide","TLC-6740 tablet + subcutaneous injection of tirzepatide",[19,30],"Drug: Tirzepatide",{"label":32,"type":10,"description":33,"interventionNames":34},"Placebo + Tirzepatide","TLC-6740 placebo + subcutaneous injection of tirzepatide",null,[36,40,45,48,50,54],{"type":37,"name":38,"description":11,"armGroupLabels":39,"otherNames":34},"DRUG","TLC-6740 Oral Solution",[9],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":34},"OTHER","Placebo Oral Solution","Placebo-to-match oral solution TLC-6740",[9],{"type":37,"name":46,"description":17,"armGroupLabels":47,"otherNames":34},"TLC-6740 Tablet",[22,27,16],{"type":37,"name":22,"description":23,"armGroupLabels":49,"otherNames":34},[22],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":34},"Tirzepatide","Subcutaneous injection of tirzepatide",[27],{"type":41,"name":55,"description":56,"armGroupLabels":57,"otherNames":34},"Placebo Tablet","Placebo-to-match tablet formulation of TLC-6740",[16],[59],{"name":60,"affiliation":5,"role":61},"OrsoBio Study Director","STUDY_DIRECTOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":34,"email":67},"Ryan Huss, MD","CONTACT","650-382-2225","Clinicaltrials_Inquires@orsobio.com",[69,81,86,91],{"facility":70,"status":71,"city":72,"state":34,"zip":34,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":34},"OrsoBio Auckland Research Site 1","RECRUITING","Auckland","New Zealand","NZ",{"type":76,"coordinates":77},"Point",[78,79],174.76349,-36.84853,{"lat":79,"lon":78},{"facility":82,"status":71,"city":72,"state":34,"zip":34,"country":73,"countryCode":74,"cosmosGeoPoint":83,"geoPoint":85,"contacts":34},"OrsoBio Auckland Research Site 2",{"type":76,"coordinates":84},[78,79],{"lat":79,"lon":78},{"facility":87,"status":71,"city":72,"state":34,"zip":34,"country":73,"countryCode":74,"cosmosGeoPoint":88,"geoPoint":90,"contacts":34},"OrsoBio Auckland Research Site 3",{"type":76,"coordinates":89},[78,79],{"lat":79,"lon":78},{"facility":92,"status":71,"city":93,"state":34,"zip":34,"country":73,"countryCode":74,"cosmosGeoPoint":94,"geoPoint":98,"contacts":34},"OrsoBio Research Site","Christchurch",{"type":76,"coordinates":95},[96,97],172.63333,-43.53333,{"lat":97,"lon":96},{"type":100,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100502460","phase-1-phase-11b-study-of-tlc-6740-in-healthy-subjects-and-subjects-with-obesity-with-or-without-diabetes-100502460",false,"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.",true,"ALL","18 Years","70 Years",{"count":113,"type":114},564,"ESTIMATED","INTERVENTIONAL",[117],"PHASE1","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.",[120,121,122],"Healthy Subjects","Obesity","Type 2 Diabetes","2025-12-10",{"date":125,"type":126},"2025-12-18","ACTUAL",{"date":128,"type":126},"2023-04-22",{"date":130,"type":114},"2026-06",{"name":5,"class":6},4]