A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

This study is a randomized, double-blind, placebo-controlled trial aimed at exploring the effects of LAE102 injection in combination with Tirzepatide on body composition.

It had two arms (groups): Treatment group (experimental) and Placebo group (placebo comparator).

Receive LAE102, once a week, by subcutaneous injection.

Receive the LAE102 placebo, once a week, by subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Voluntarily participate in the study and sign the Informed Consent Form (ICF);. Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;. BMI ranging from 28.0 to 40.0 kg/m2 during the screening;.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes);; diagnosed with secondary obesity;; uncontrolled thyroid disease, or screening criteria.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 with completion listed for 2027-07.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The percentage change in lean body mass (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example Safety endpoint.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 60 people.

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

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