This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

Retatrutide

Sponsor:

Eli Lilly and Company

Code:

NCT06297603

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Retatrutide

Placebo

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT06297603

Start date

Mar 15, 2024

Status verified date

Oct, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Retatrutide Dose 1

Participants will receive retatrutide administered subcutaneously (SC).

experimental: Retatrutide Dose 2

Participants will receive retatrutide administered SC.

experimental: Retatrutide Dose 3

Participants will receive retatrutide administered SC.

placebo comparator: Placebo

Participants will receive placebo administered SC.

Interventions

Retatrutide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Change from Baseline in Hemoglobin A1c (HbA1c) (%) [ Time Frame: Baseline, Week 52 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Nephrology Consultants

Recruiting

Huntsville, Alabama, United States, 35805

Contacts

256-533-4626

Principal Investigator:

Michael Quadrini

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

Recruiting

Sun City West, Arizona, United States, 85375

Contacts

623-293-1360

Principal Investigator:

Jalal Abbas

Kidney & Hypertension Center - Apple Valley

Recruiting

Apple Valley, California, United States, 92307

Contacts

760-780-4179

Principal Investigator:

Edgard Vera

Hope Clinical Research, Inc.

Recruiting

Canoga Park, California, United States, 91303

Contacts

818-999-4676

Principal Investigator:

Hessam Aazami

Neighborhood Healthcare Institute of Health

Recruiting

Escondido, California, United States, 92025

Contacts

760-737-6984

Principal Investigator:

James Schultz

EndoTrials Center for Clinical Research

Recruiting

La Mesa, California, United States, 91942

Contacts

619-460-2626

Principal Investigator:

Darius Schneider

UCLA South Bay Endocrinology

Recruiting

Torrance, California, United States, 90505

Principal Investigator:

Dianne Cheung

Northeast Research Institute (NERI)

Recruiting

Fleming Island, Florida, United States, 32003

Contacts

904-541-8225

Principal Investigator:

Senan Sultan

Encore Medical Research - Weston

Recruiting

Weston, Florida, United States, 33331

Contacts

954-777-8827

Principal Investigator:

Sandro Bacchelli

Orita Clinical Research

Recruiting

Decatur, Georgia, United States, 30034

Principal Investigator:

Ahmad Jingo

CARE Institute

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

208-984-2273

Principal Investigator:

Hira Siktel

Cotton O'Neil Diabetes & Endocrinology

Recruiting

Topeka, Kansas, United States, 66606

Contacts

785-368-0428

Principal Investigator:

Alan Wynne

Billings Clinic

Recruiting

Billings, Montana, United States, 59101

Contacts

406-435-8470

Principal Investigator:

Lauren Kleess

Excel Clinical Research, LLC

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

702-680-1500

Principal Investigator:

Duane Anderson

Albany Medical College, Division of Community Endocrinology

Recruiting

Albany, New York, United States, 12203

Contacts

518-264-4420

Principal Investigator:

Robert Busch

NYC Research INC

Recruiting

Long Island City, New York, United States, 11106

Contacts

516-574-9232

Principal Investigator:

Anastasios Manessis

Research Foundation of SUNY - University of Buffalo

Recruiting

Williamsville, New York, United States, 14221

Contacts

716-535-1850

Principal Investigator:

Ajay Chaudhuri

University of North Carolina Medical Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

984-974-3004

Principal Investigator:

Klara Klein

Central States Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

918-645-5400

Principal Investigator:

Sarah Land

Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

412-942-0023

Principal Investigator:

Daniel Austin

AM Diabetes & Endocrinology Center

Recruiting

Bartlett, Tennessee, United States, 38133

Contacts

901-384-0065

Principal Investigator:

Kashif Latif

Velocity Clinical Research, Dallas

Recruiting

Dallas, Texas, United States, 75230

Principal Investigator:

Dan Lender

Prime Revival Research Institute, LLC

Recruiting

Flower Mound, Texas, United States, 75098

Contacts

214-432-1198

Principal Investigator:

WASIM HAQUE

Juno Research

Recruiting

Houston, Texas, United States, 77040

Contacts

713-779-5494

Principal Investigator:

Damaris Vega

PlanIt Research, PLLC

Recruiting

Houston, Texas, United States, 77079

Contacts

713-973-3415

Principal Investigator:

Prashant Koshy

Southern Endocrinology Associates

Recruiting

Mesquite, Texas, United States, 75149

Contacts

214-693-0904

Principal Investigator:

Sumana Gangi

Texas Valley Clinical Research

Recruiting

Weslaco, Texas, United States, 78596

Contacts

956-431-8090

Principal Investigator:

Eduardo Luna

Diabetes & Endocrine Treatment Specialists

Recruiting

Sandy City, Utah, United States, 84093

Contacts

801-816-1010

Principal Investigator:

Timothy Graham

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Keywords

  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Kidney Disease
  • Renal Insufficiency Chronic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2025-10-16.