Current partner codePEPTIDESDE
NCT05929066·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

2,335

Locations

134

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). 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.

Interventions

Treatment arms and agents.

DRUG

Retatrutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Jul 3, 2023

  2. Study start

    Jul 10, 2023

  3. Primary completion

    Apr 6, 2026

  4. Study completion

    Apr 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jun 3, 2026

Outcomes

What the study measures.

Primary outcomes

Percent Change From Baseline in Body Weight

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

Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset

Time frame · Baseline, Week 80

Percent Change from Baseline in Body Weight to

Time frame · Baseline, Week 104

Secondary outcomes

Change from Baseline in Body Mass Index (BMI)

Time frame · Baseline, Week 80

Change from Baseline in Waist Circumference

Time frame · Baseline, Week 80

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame · Baseline, Week 80

Percent Change form Baseline in Fasting Insulin

Time frame · Baseline, Week 80

Change from Baseline in HbA1c

Time frame · Baseline, Week 80

Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame · Baseline, Week 80

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

Time frame · Baseline through Week 80

AUC is presented as a single average measure of AUC across the study duration.

Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset

Time frame · Baseline, Week 80

Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset

Time frame · Baseline, Week 80

Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset

Time frame · Baseline, Week 80

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease * History of of at least one unsuccessful dietary effort to reduce body weight GOA1 Inclusion Criteria: * 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. GSA1 Inclusion Criteria: * Previously diagnosed with OSA * Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA) * For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening. * If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits. GZBJ Addenda (2) inclusion criteria: * Have completed the final treatment visit of GZBJ Week 80. Exclusion Criteria: * 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. * Have diabetes mellitus. * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had pancreatitis. GOA1 exclusion criteria * Have had steroid joint injections within 90 days of screening. * Have had other joint injections and procedures within 6 months of screening. * Have joint disease other than osteoarthritis. GSA1 exclusion criteria * Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening. * Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening. * Use a dental appliance or other device to treat OSA other than PAP therapy. GZBJ Addenda (2) exclusion criteria * Have had study intervention discontinuation. * Have had permanent dose reduction.

Study locations

134 registered sites.

Australia · Brazil · Canada · Hungary · India · Mexico · Poland · Puerto Rico · Romania · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Medical Investigations

Little Rock, Arkansas, United States

Neuro-Pain Medical Center

Fresno, California, United States

Valley Research

Fresno, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Teradan Clinical Trials, LLC

Brandon, Florida, United States

Suncoast Research Group

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

NeuroTrials Research Inc

Atlanta, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

Springfield, Illinois, United States

Brengle Family Medicine

Indianapolis, Indiana, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

MedVadis Research Corporation

Waltham, Massachusetts, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

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