Current partner codePEPTIDESDE
NCT05929079·Phase 3·INTERVENTIONAL

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Status

Completed

Phase

Phase 3

Enrollment

1,152

Locations

98

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

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 11, 2023

  3. Primary completion

    Jun 16, 2026

  4. Study completion

    Jun 16, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 30, 2026

Outcomes

What the study measures.

Primary outcomes

Percent Change from Baseline in Body Weight

Time frame · Baseline, Week 80

Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset

Time frame · Baseline, Week 80

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

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame · Baseline, Week 80

Percent Change from Baseline in Total Cholesterol

Time frame · Baseline, Week 80

Percent Change from Baseline in Triglycerides

Time frame · Baseline, Week 80

Change from Baseline in Hemoglobin (A1c) 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

Change from Baseline in Fasting Glucose

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.

Eligibility

Who can take part.

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

Inclusion Criteria: * Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²) * Have Type 2 Diabetes (T2D) * Are on stable treatment for T2D for at least 90 days * Have a history of at least one unsuccessful dietary effort to lose body weight. GSA2 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. 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 Type 1 diabetes * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had pancreatitis GSA2 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.

Study locations

98 registered sites.

Argentina · Australia · Brazil · India · Mexico · Romania · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Core Healthcare Group

Cerritos, California, United States

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Teradan Clinical Trials, LLC

Brandon, Florida, United States

Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Therafirst Medical Center

Fort Lauderdale, Florida, United States

Clinical Site Partners LLC, dba Flourish Research

Miami, Florida, United States

Quantum Clinical Trials

Miami Beach, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

NeuroTrials Research Inc

Atlanta, Georgia, United States

Centricity Research Rincon Pulmonology

Rincon, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Brengle Family Medicine

Indianapolis, Indiana, United States

MedVadis Research Corporation

Waltham, Massachusetts, 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.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.