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HomeTrials › NCT06297603

Type 2 diabetes · Phase 3 · Active, not recruiting

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

NCT06297603 · 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.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeRetatrutide, Placebo
Study length~2.6 years overall
Planned participants320
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 placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 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 moderate or severe renal impairment * Have been on the following stable diabetes treatment during 90 days prior to screening * basal insulin (≥20 International Units (IU)/day) with or without * metformin and/or SGLT2 inhibitor * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2) 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 a history of unstable or rapidly progressing renal disease * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification III or IV congestive heart failure * Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * 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

  • Nephrology Consultants — Huntsville

Arizona

  • Clinical Research Institute of Arizona (CRI) - Sun City West — Sun City West

California

  • Kidney & Hypertension Center - Apple Valley — Apple Valley
  • Hope Clinical Research, Inc. — Canoga Park
  • Neighborhood Healthcare Institute of Health — Escondido
  • EndoTrials Center for Clinical Research — La Mesa
  • UCLA South Bay Endocrinology — Torrance

Florida

  • Northeast Research Institute (NERI) — Fleming Island
  • Encore Medical Research - Weston — Weston

Georgia

  • Orita Clinical Research — Decatur

Idaho

  • CARE Institute — Idaho Falls

Kansas

  • Cotton O'Neil Diabetes & Endocrinology — Topeka

Montana

  • Billings Clinic — Billings

Nevada

  • Excel Clinical Research, LLC — Las Vegas

New York

  • Albany Medical College, Division of Community Endocrinology — Albany
  • NYC Research INC — Long Island City
  • Research Foundation of SUNY - University of Buffalo — Williamsville

North Carolina

  • University of North Carolina Medical Center — Chapel Hill

Oklahoma

  • Central States Research — Tulsa

Pennsylvania

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair — Pittsburgh

Tennessee

  • AM Diabetes & Endocrinology Center — Bartlett

Texas

  • Velocity Clinical Research, Dallas — Dallas
  • Prime Revival Research Institute, LLC — Flower Mound
  • Juno Research — Houston
  • PlanIt Research, PLLC — Houston
  • Southern Endocrinology Associates — Mesquite
  • Texas Valley Clinical Research — Weslaco

Utah

  • Diabetes & Endocrine Treatment Specialists — Sandy City

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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