> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-1b-study-of-tlc-6740-in-healthy-subjects-and-de500b60-a3de-4cb1-9005-a51fdfe3d3d2 > Record changed: 2026-10-13 # Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes NCT05822544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) Participants 564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) Lead sponsor OrsoBio, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) Start date 2023-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Short title** Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Official title** A Phase 1/1b 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Dates **Completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **First posted** 2023-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Primary completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Start date** 2023-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Size and sites **Participants** 564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Planned participants** 564 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Lead sponsor** OrsoBio, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Identifiers **Registry ID** NCT05822544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **ClinicalTrials.gov ID** NCT05822544 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Outcomes ### Primary outcomes 1. Incidence of TLC-6740 treatment-emergent adverse events Timeframe: Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related. 2. PK of TLC-6740 AUC Timeframe: Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study Area under the concentration-time curve 3. PK of TLC-6740 Cmax Timeframe: Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study Maximum plasma concentration 4. PK of TLC-6740 tmax Timeframe: Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study Time to reach Cmax 5. PK of TLC-6740 t1/2 Timeframe: Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study Half-life 6. PK of TLC-6740 CL/F Timeframe: Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 168 (Parts F, G) of the study Apparent clearance, calculated as dose/AUC0-inf Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** Yes ### Inclusion criteria - 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) - Body mass index (BMI) from 19 to 35 kg/m2, inclusive (Parts A-E); BMI ≥ 30 kg/m2 and ≤ 50 kg/m2 (Parts F, G) - Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min (Parts A-E); eGFR ≥ 60 mL/min/1.73m2 or eGFR ≥ 45 mL/min/1.73m2, depending on cohort (Parts F, G) - ALT/AST/ALP ≤ 1 x ULN (Parts A-E); ALT/AST < 3 x ULN, ALP < 1.5 x ULN (Parts F, G) - 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) - Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator - Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission - Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception - Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs ### Exclusion criteria - Pregnant or lactating subjects - Unstable type 2 diabetes (as defined as: HbA1c > 10.0%; treatment with insulin and/or pioglitazone within 90 days prior to Screening; any history of diabetic ketoacidosis, hyperosmolar state, and/or 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) - History of type 2 diabetes diagnosed prior - Medical history of type 1 diabetes or latent autoimmune diabetes of adults (LADA) - 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) - Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide (Part G) - 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 - Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing - Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety - Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety - A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody - Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity) - Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and/or clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction < 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years - Syncope, palpitations, or unexplained dizziness - Implanted defibrillator or pacemaker - 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) - Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions - History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery) - Subjects who have received vaccination for COVID-19 within 14 days of Admission Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Sites - OrsoBio Auckland Research Site 1Auckland, New Zealand - OrsoBio Auckland Research Site 2Auckland, New Zealand - OrsoBio Auckland Research Site 3Auckland, New Zealand - OrsoBio Research SiteChristchurch, New Zealand Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05822544) ## Related records ### Drugs (4) - [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md) - [Saruplase](https://trialight.com/data/asset/saruplase-b321be62-b17c-4e99-be93-cf42b78a820f.md) - [Tirzepatide](https://trialight.com/data/asset/tirzepatide-eed85871-eb9c-4712-9102-badfdd99a720.md) - [Xevinapant](https://trialight.com/data/asset/xevinapant-370661d9-6fbe-420d-8cc6-990263e53aec.md) ### Lead sponsors (1) - [OrsoBio, Inc](https://trialight.com/data/company/orsobio-inc-4e9d7961-b3a2-4550-8e66-194ac3dc1f9f.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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