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HomeTrials › NCT06260722

Type 2 diabetes · Phase 3 · Active, not recruiting

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

NCT06260722 · 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, Semaglutide for diabetes mellitus, type 2.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeRetatrutide, Semaglutide
Study length~2.4 years overall
Planned participants1,250
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 investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may 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 Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Study sites by state

Alabama

  • University of Alabama - Department of Nutrition Sciences — Birmingham

California

  • Neighborhood Healthcare Institute of Health — Escondido
  • Long Beach Research Institute — Long Beach
  • Valley Clinical Trials, Inc. — Northridge
  • Rancho Cucamonga Clinical Research — Rancho Cucamonga

Colorado

  • University of Colorado Anschutz Medical Campus — Aurora

Florida

  • Arrow Clinical Trials — Daytona Beach
  • New Age Medical Research Corporation — Miami
  • South Broward Research — Miramar
  • Clinical Research of Central Florida — Winter Haven

Georgia

  • Herman Clinical Research — Suwanee
  • North Georgia Clinical Research — Woodstock

Hawaii

  • Pacific Diabetes & Endocrine Center — Honolulu

Idaho

  • Rocky Mountain Clinical Research — Idaho Falls

Indiana

  • Deaconess Clinic - Gateway Health Center — Newburgh

Louisiana

  • IMA Clinical Research Monroe - Armand — Monroe

Maryland

  • MedStar Health Research Institute (MedStar Physician Based Research Network) — Hyattsville

Massachusetts

  • Brigham and Women's Hospital Diabetes Program — Boston
  • NECCR PrimaCare Research — Fall River

Michigan

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy

Nevada

  • Palm Research Center Tenaya — Las Vegas
  • Palm Research Center Sunset — Las Vegas

New York

  • NYC Research INC — Long Island City

North Carolina

  • Medication Management — Greensboro

Ohio

  • Remington Davis Clinical Research — Columbus

Oklahoma

  • Alliance for Multispecialty Research, LLC — Norman
  • Central States Research — Tulsa

Oregon

  • The Corvallis Clinic, P.C. — Corvallis

Pennsylvania

  • Thomas Jefferson University Hospital — Philadelphia

Texas

  • Velocity Clinical Research, Dallas — Dallas
  • Valley Institute of Research - Fort Worth — Fort Worth
  • Juno Research — Houston
  • Southern Endocrinology Associates — Mesquite
  • Consano Clinical Research, LLC — Shavano Park
  • Texas Valley Clinical Research — Weslaco
  • Medrasa Clinical Research — Wylie

Washington

  • Central Washington Health Services Association d/b/a Confluence Health — Wenatchee

West Virginia

  • IMA Clinical Research West Virginia — Morgantown

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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