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A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Plain-language guide to NCT06124807: phase 2 randomized trial of Mazdutide, 179 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06124807
Phase
phase 2
Status
completed
Start
2023-11-17
Completion (planned or actual)
2025-01-22
Participants
179 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Obesity; Overweight and Obesity
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Mazdutide.

The study will last about 62 weeks.

The registry classes the interventions as drug.

Who Took Part

179 actual participants took part.

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: Are males and females who agree to abide by the reproductive and contraceptive requirements. Have a BMI ≥27 kilograms per square meter (kg/m²).

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (t2dm), or rare forms of diabetes mellitus, except gestational diabetes; have any of the following cardiovascular conditions within 6 months prior to screening:; acute myocardial infarction.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Mazdutide 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 Mazdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-11-17 with completion listed for 2025-01-22.

It ran at 29 sites in United States (29).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Body Weight at Week 32 (time frame: Baseline, Week 32).

It also tracked 14 secondary outcomes, for example Percent Change From Baseline in Body Weight at Week 48, Change From Baseline in Body Weight, Change From Baseline in Body Mass Index (BMI), Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs) and PK: Maximum Concentration (Cmax) of Mazdutide at Steady State.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Mazdutide in 179 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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

Our Notes on the Compound

Mazdutide: A dual GLP-1 and glucagon receptor agonist with approvals announced in China for weight management and type 2 diabetes.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.