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A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Plain-language guide to NCT05882045: phase 3 randomized trial of Retatrutide, 1946 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05882045
Phase
phase 3
Status
completed
Start
2023-05-30
Completion (planned or actual)
2026-04-16
Participants
1946 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Obesity; Cardiovascular Diseases
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Retatrutide.

The study will last about 113 weeks.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Participants will receive retatrutide subcutaneously (SC).

Participants will receive retatrutide SC.

Participants will receive placebo.

The registry classes the interventions as drug.

Who Took Part

1946 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²). Have established cardiovascular (CV) disease with at least 1 of the following:. Prior myocardial infarction. Prior ischemic or hemorrhagic stroke, or. Symptomatic peripheral arterial disease.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening; have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening; have a prior or planned surgical treatment of obesity.

How the Study Was Run

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

The participants were allocated by chance, so the Retatrutide 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 Retatrutide.

Those kept unaware of assignments: participant and investigator.

It started in 2023-05-30 with completion listed for 2026-04-16.

It ran at 169 sites in United States (46), Argentina (24), Australia (19), Canada (17), Mexico (16) and Spain (14).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change from Baseline in Body Weight (time frame: Baseline, Week 80).

It also tracked 10 secondary outcomes, for example Change from Baseline in Body Mass Index (BMI), Change from Baseline in Waist Circumference, Percent Change from Baseline in Total Cholesterol, Percent Change from Baseline in Triglycerides, Change from Baseline in Systolic Blood Pressure (SBP) and Change from Baseline in Diastolic Blood Pressure (DBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Retatrutide in 1946 people.

With 1946 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Retatrutide: A single-molecule triple agonist (GLP-1, GIP and glucagon receptors).

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.