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

What Was Tested

This registered phase 1 trial tested Tirzepatide.

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.

It had five arms (groups): Oral Solution (experimental), Tablet (experimental), Drug Metabolizing Enzyme (experimental), TLC-6740 + Tirzepatide (experimental) and Placebo + Tirzepatide (experimental).

Oral solution of TLC-6740.

Tablet formulation of TLC-6740.

The registry classes the interventions as drug and other.

More on the Plan

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.

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.

Who Took Part

564 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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). 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.

The full record lists 9 inclusion and 19 exclusion criteria; among the exclusions: pregnant or lactating subjects; history of type 2 diabetes diagnosed prior; medical history of type 1 diabetes or latent autoimmune diabetes of adults (lada).

How the Study Was Run

The set-up was randomized, sequential and double-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-04-22 with completion listed for 2026-09.

It ran at 4 sites in New Zealand (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of TLC-6740 treatment-emergent adverse events. PK of TLC-6740 AUC. PK of TLC-6740 Cmax.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 564 people.

With 564 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.