A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

What Was Tested

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

The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs.

The ISAs may start independently of other ISAs as interventions become available for clinical testing.

It had six arms (groups): LY3305677 Obesity ISA OXA1 (experimental), LY3841136 Obesity ISA LAA1 (experimental), LY3841136 Obesity ISA LAA2 (experimental), LY3549492 Obesity ISA GN01 (experimental) and LY3549492 Obesity ISA GN02 (experimental).

Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.

Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.

Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.

The registry classes the interventions as drug.

Who Took Part

1481 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: Have a body mass index (BMI). ≥30 kilogram/square meter (kg/m²), or. ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening; have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma; have poorly controlled hypertension.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2023-11-17 with completion listed for 2027-09.

It ran at 57 sites in United States (50) and Argentina (7).

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): Number of Participants Allocated to Each ISA (time frame: Baseline to Week 6).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide and Mazdutide in 1481 people.

With 1481 participants it is a large trial for this field.

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

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