A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight

What Was Tested

This registered phase 1 trial tested Tirzepatide.

It had nine arms (groups): SAD Cohort 1 (experimental), SAD Cohort 2 (experimental), SAD Cohort 3 (experimental), SAD Cohort 4 (experimental) and MAD Cohort 0 (active comparator).

The registry classes the interventions as drug.

Who Took Part

84 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site. Are between 18 and 65 years of age (both inclusive) at time of screening.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: have any prior diagnosis of diabetes mellitus (t1dm or t2dm), history of ketoacidosis, or hyperosmolar state/coma; have an autoimmune disease, is immunosuppressed or is in any way immunocompromised; have a history of acute or chronic pancreatitis.

How the Study Was Run

It was run as a randomized, sequential and triple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2026-08-27 with completion listed for 2027-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Adverse events (time frame: Baseline and Day 141).

It also tracked 5 secondary outcomes, for example Cmax of ASC35, Tmax of ASC35, AUC of ASC35, Change From Baseline in Body Weight and Change From Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 84 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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