NCT05822544

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 564 (estimated)
• Sponsor: OrsoBio, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objectives are to assess the safety, tolerability, and plasma PK of TLC-6740 in healthy subjects and subjects with obesity. The exploratory objective is to evaluate the PD of TLC-6740 in healthy subjects and subjects with obesity, with or without type 2 diabetes. This study is comprised of seven parts: Part A (single-ascending dose), Part B (multiple-ascending dose), Part C (adaptive single- and/or multiple-ascending dose), Part D (relative bioavailability of a tablet formulation of TLC-6740), Part E (drug-drug interaction study to determine the effect of TLC-6740 on drug metabolizing enzymes), Part F (multiple dose of TLC-6740 in subjects with obesity with or without type 2 diabetes mellitus), and Part G (multiple dose of TLC-6740 in subjects with obesity receiving tirzepatide). Up to 48, 50, 100, 8, and 28 healthy subjects will be recruited in Parts A, B, C, D, and E, respectively. Up to 180 and 150 obese subjects will be recruited in Parts F and G, respectively. The effect of food on TLC-6740 PK will also be evaluated in this study.

Conditions

• Healthy Subjects
• Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	TLC-6740 Oral Solution	Oral solution of TLC-6740
OTHER	Placebo Oral Solution	Placebo-to-match oral solution TLC-6740
DRUG	TLC-6740 Tablet	Tablet formulation of TLC-6740
DRUG	Drug Metabolizing Enzyme	Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin
DRUG	Tirzepatide	Subcutaneous injection of tirzepatide
OTHER	Placebo Tablet	Placebo-to-match tablet formulation of TLC-6740

Timeline

• Start date: 2023-04-22
• Primary completion: 2026-02-01
• Completion: 2026-06-01
• First posted: 2023-04-20
• Last updated: 2025-12-18

Locations

4 sites across 1 country: New Zealand