Current partner codePEPTIDESDE
NCT06260722·Phase 3·INTERVENTIONAL

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)

Status

Active, not recruiting

Phase

Phase 3

Enrollment

1,250

Locations

77

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 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.

Interventions

Treatment arms and agents.

DRUG

Retatrutide

Administered SC.

DRUG

Semaglutide

Administered SC.

Timeline

From registration to results.

  1. First posted

    Feb 15, 2024

  2. Study start

    Feb 21, 2024

  3. Primary completion

    Aug 2026

  4. Study completion

    Jan 2027

  5. Results posted

    Not reported

  6. Registry updated

    Apr 13, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline, Week 80

Secondary outcomes

Change from Baseline in HbA1c (%)

Time frame · Baseline, Week 80

Percentage of Participants Who Achieve HbA1c ≤ 6.5%

Time frame · Week 80

Percentage of Participants Who Achieve HbA1c < 5.7%

Time frame · Week 80

Percent Change from Baseline in Body Weight

Time frame · Week 80

Change from Baseline in Body Weight

Time frame · Baseline, Week 80

Percentage of Participants Who Achieve Weight Reduction of ≥ 5%

Time frame · Week 80

Percentage of Participants Who Achieve Weight Reduction of ≥ 10%

Time frame · Week 80

Percentage of Participants Who Achieve Weight Reduction of ≥ 15%

Time frame · Week 80

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

Time frame · Week 80

Percent Change from Baseline in Triglycerides

Time frame · Week 80

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 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 locations

77 registered sites.

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

University of Alabama - Department of Nutrition Sciences

Birmingham, Alabama, United States

Neighborhood Healthcare Institute of Health

Escondido, California, United States

Long Beach Research Institute

Long Beach, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

New Age Medical Research Corporation

Miami, Florida, United States

South Broward Research

Miramar, Florida, United States

Clinical Research of Central Florida

Winter Haven, Florida, United States

Herman Clinical Research

Suwanee, Georgia, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Deaconess Clinic - Gateway Health Center

Newburgh, Indiana, United States

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, United States

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, United States

Brigham and Women's Hospital Diabetes Program

Boston, Massachusetts, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Palm Research Center Sunset

Las Vegas, Nevada, United States

NYC Research INC

Long Island City, New York, United States

Medication Management

Greensboro, North Carolina, 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.