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

NCT05822544 · Recruiting

Last updated 2026-05-28

This clinical trial tests the safety of a new drug called TLC-6740 in healthy people, people with obesity, and people with obesity and type 2 diabetes.

Status Recruiting Currently enrolling participants.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 564 people Planned (estimated).

Who can join Ages 18–70 · all sexes Healthy volunteers accepted.

Timeline Started 2023-04 · est. completion 2026-06

Where 4 sites · New Zealand

What this study is testing ClinicalTrials.gov NCT05822544 ↗

Description as written by the study sponsor.

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.

Treatments tested

TLC-6740 Oral Solution Drug

Oral solution of TLC-6740
Placebo Oral Solution Other

Placebo-to-match oral solution TLC-6740
TLC-6740 Tablet Drug

Tablet formulation of TLC-6740
Drug Metabolizing Enzyme Drug

Oral dose of omeprazole, voriconazole, itraconazole, or rifampicin
Tirzepatide Drug

Subcutaneous injection of tirzepatide
Placebo Tablet Other

Placebo-to-match tablet formulation of TLC-6740

Main thing measured	Incidence of TLC-6740 treatment-emergent adverse events
Sponsor	OrsoBio, Inc
Conditions studied	Healthy Subjects, Obesity, Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05822544 ↗