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A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Plain-language guide to NCT05929066: phase 3 randomized trial of Retatrutide, sleep apnea (obstructive), 2335 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05929066
Phase
phase 3
Status
completed
Start
2023-07-10
Completion (planned or actual)
2026-04-06
Participants
2335 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Obesity; Overweight; Osteoarthritis, Knee; Obstructive Sleep Apnea
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Retatrutide for sleep apnea (obstructive).

This study will last about 89 weeks and will include up to 24 visits.

Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

It had five arms (groups): one (experimental), one (experimental), one (experimental), Placebo (placebo comparator) and Retatrutide Extension Period (experimental).

Participants will receive retatrutide subcutaneously (SC).

Participants will receive retatrutide SC.

Participants will receive retatrutide SC.

The registry classes the interventions as drug.

Who Took Part

2335 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 body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:. Obstructive sleep apnea, or. Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month. Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening. Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

The full record lists 14 inclusion and 14 exclusion criteria; among the exclusions: have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days; have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening; have a prior or planned surgical treatment for obesity.

How the Study Was Run

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

Because people in this Retatrutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the sleep apnea (obstructive) participants stayed in one arm throughout.

Neither the sleep apnea (obstructive) participants nor the staff measuring them knew who was on Retatrutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-07-10 with completion listed for 2026-04-06.

It ran at 134 sites in United States (39), Mexico (15), India (14), Poland (12), Romania (10) and Canada (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Body Weight (time frame: Baseline, Week 80). Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset (time frame: Baseline, Week 80). Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset (time frame: Baseline, Week 80).

It also tracked 49 secondary outcomes, for example Percent Change from Baseline in Body Weight in Participants with Baseline BMI ≥ 35 kg/m2, Change from Baseline in Waist Circumference, Change from Baseline in Systolic Blood Pressure (SBP), Percent Change from Baseline in Triglycerides, Percent Change from Baseline in Non-High-Density Lipoprotein (HDL)-Cholesterol and Percent Change form Baseline in Fasting Insulin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Retatrutide in 2335 people with sleep apnea (obstructive).

With 2335 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, Sleep apnea (obstructive) research.

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.