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HomeTrials › NCT05929079

Obesity & weight · Phase 3 · Active, not recruiting

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

NCT05929079 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Retatrutide, Placebo for type 2 diabetes, obesity, overweight.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeRetatrutide, Placebo
Study length~2.8 years overall
Planned participants1,000
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Alabama

  • Pinnacle Research Group, LLC — Anniston
  • Cullman Clinical Trials — Cullman

Arkansas

  • Preferred Research Partners — Little Rock

California

  • Core Healthcare Group — Cerritos
  • Velocity Clinical Research, Westlake — Los Angeles
  • Valley Clinical Trials, Inc. — Northridge
  • Diablo Clinical Research, Inc. — Walnut Creek

Connecticut

  • Chase Medical Research, LLC — Waterbury

Florida

  • Excel Medical Clinical Trials — Boca Raton
  • Teradan Clinical Trials, LLC — Brandon
  • Fleming Island Center for Clinical Research — Fleming Island
  • Therafirst Medical Center — Fort Lauderdale
  • Clinical Site Partners LLC, dba Flourish Research — Miami
  • Quantum Clinical Trials — Miami Beach
  • Renstar Medical Research — Ocala
  • Clinical Research Center of Florida — Pompano Beach
  • Palm Beach Research Center — West Palm Beach
  • Clinical Site Partners, LLC dba Flourish Research — Winter Park

Georgia

  • NeuroTrials Research Inc — Atlanta
  • Centricity Research Rincon Pulmonology — Rincon

Hawaii

  • East-West Medical Research Institute — Honolulu

Indiana

  • Brengle Family Medicine — Indianapolis

Massachusetts

  • MedVadis Research Corporation — Waltham

Missouri

  • StudyMetrix Research — City of Saint Peters

Nevada

  • Las Vegas Medical Research — Las Vegas

New York

  • Mid Hudson Medical Research — New Windsor

North Carolina

  • Monroe Biomedical Research — Monroe
  • Carteret Medical Group — Morehead City

North Dakota

  • Lillestol Research — Fargo

Ohio

  • CTI Clinical Research Center — Cincinnati
  • Intrepid Research — Cincinnati

Pennsylvania

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) — Pittsburgh
  • Preferred Primary Care Physicians — Uniontown

South Carolina

  • Tribe Clinical Research, LLC — Greenville
  • Trial Management Associates — Myrtle Beach
  • Tribe Clinical Research - Spartanburg — Spartanburg

Texas

  • FutureSearch Trials of Neurology — Austin
  • Velocity Clinical Research, Dallas — Dallas

Utah

  • Advanced Research Institute — Ogden

Washington

  • Northwest Clinical Research Center — Bellevue

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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