Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity

Obesity Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. This study is comprised of six 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), and Part F (phase 1b). Up to 48, 50, 50, 8, and 20 healthy subjects will be recruited in Parts A, B, C, D, and E, respectively. Up to 60 obese subjects will be recruited in Part F. The effect of food on TLC-6740 PK will also be evaluated in this study. ;

Related Conditions & MeSH terms

• Healthy Subjects
• Obesity

• NCT number: NCT05822544
• Study type: Interventional
• Source: OrsoBio, Inc
• Contact: Ryan Huss, MD
• Phone: 650-382-2225
• Email: Clinicaltrials_Inquires@orsobio.com
• Status: Recruiting
• Phase: Phase 1
• Start date: April 22, 2023
• Completion date: March 2025