Current partner codePEPTIDESDE
NCT06297603·Phase 3·INTERVENTIONAL

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)

Status

Active, not recruiting

Phase

Phase 3

Enrollment

320

Locations

76

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Retatrutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Mar 7, 2024

  2. Study start

    Mar 15, 2024

  3. Primary completion

    Oct 2026

  4. Study completion

    Nov 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c) (%)

Time frame · Baseline, Week 52

Secondary outcomes

Percentage of Participants Achieving HbA1c <7.0%

Time frame · Week 52

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame · Week 52

Change from Baseline in Fasting Serum Glucose

Time frame · Baseline, Week 52

Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL

Time frame · Week 52

Measured during the CGM session that occurs during 30 days prior to Week 52

Percent Change from Baseline in Body Weight

Time frame · Baseline, Week 52

Change from Baseline in Body Weight

Time frame · Baseline, Week 52

Percentage of Participants Achieving Weight Reduction of ≥5%

Time frame · Week 52

Percentage of Participants Achieving Weight Reduction of ≥10%

Time frame · Week 52

Percentage of Participants Achieving Weight Reduction of ≥15%

Time frame · Week 52

Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction

Time frame · Week 52

Eligibility

Who can take part.

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

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 locations

76 registered sites.

Argentina · Brazil · Israel · Mexico · Puerto Rico · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Nephrology Consultants

Huntsville, Alabama, United States

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

Sun City West, Arizona, United States

Kidney & Hypertension Center - Apple Valley

Apple Valley, California, United States

Hope Clinical Research, Inc.

Canoga Park, California, United States

Neighborhood Healthcare Institute of Health

Escondido, California, United States

EndoTrials Center for Clinical Research

La Mesa, California, United States

UCLA South Bay Endocrinology

Torrance, California, United States

Northeast Research Institute (NERI)

Fleming Island, Florida, United States

Encore Medical Research - Weston

Weston, Florida, United States

Orita Clinical Research

Decatur, Georgia, United States

CARE Institute

Idaho Falls, Idaho, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Billings Clinic

Billings, Montana, United States

Excel Clinical Research, LLC

Las Vegas, Nevada, United States

Albany Medical College, Division of Community Endocrinology

Albany, New York, United States

NYC Research INC

Long Island City, New York, United States

Research Foundation of SUNY - University of Buffalo

Williamsville, New York, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Central States Research

Tulsa, Oklahoma, United States

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

Pittsburgh, Pennsylvania, United States

AM Diabetes & Endocrinology Center

Bartlett, Tennessee, United States

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Prime Revival Research Institute, LLC

Flower Mound, Texas, United States

Juno Research

Houston, Texas, 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.