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NCT06354660·Phase 3·INTERVENTIONAL

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Status

Completed

Phase

Phase 3

Enrollment

537

Locations

48

Results

Not posted

Publications

1

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 inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

Interventions

Treatment arms and agents.

DRUG

Retatrutide

Administered SC.

DRUG

Placebo

Administered SC.

Timeline

From registration to results.

  1. First posted

    Apr 9, 2024

  2. Study start

    Apr 10, 2024

  3. Primary completion

    Jan 22, 2026

  4. Study completion

    Feb 20, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 5, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline, Week 40

Secondary outcomes

Percentage of Participants Who Achieve HbA1c < 7.0%

Time frame · Week 40

Percentage of Participants Who Achieve HbA1c ≤ 6.5%

Time frame · Week 40

Percentage of Participants Who Achieve HbA1c < 5.7%

Time frame · Week 40

Change from Baseline in Fasting Serum Glucose

Time frame · Baseline, Week 40

Percent Change from Baseline in Body Weight

Time frame · Baseline, Week 40

Change from Baseline in Body Weight

Time frame · Baseline, Week 40

Percentage of Participants Who Achieve Weight Reduction of ≥ 5%

Time frame · Week 40

Percentage of Participants Who Achieve Weight Reduction of ≥ 10%

Time frame · Week 40

Percentage of Participants Who Achieve Weight Reduction of ≥ 15%

Time frame · Week 40

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

Time frame · Week 40

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% to ≤ 9.5% * Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening * 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/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) \<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) 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

48 registered sites.

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

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Tucson Clinical Research Institute

Tucson, Arizona, United States

San Fernando Valley Health Institute

Canoga Park, California, United States

Ark Clinical Research

Long Beach, California, United States

Northeast Research Institute (NERI)

Fleming Island, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Ezy Medical Research

Miami, Florida, United States

Clinical Research of Central Florida

Winter Haven, Florida, United States

Trinity Research Centers

Marietta, Georgia, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

Boeson Research MSO

Missoula, Montana, United States

NJ MedCare & NJ Heart

Linden, New Jersey, United States

Accellacare - Wilmington - 1917 Tradd Court

Wilmington, North Carolina, United States

Providence Health Partners-Center for Clinical Research

Dayton, Ohio, United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Delricht Research - Tobias Gadson Boulevard - Charleston

Charleston, South Carolina, United States

Lifedoc Research - Lenox Park Drive

Memphis, Tennessee, United States

Clinical Research Associates Inc

Nashville, Tennessee, United States

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Prime Revival Research Institute, LLC

Flower Mound, Texas, United States

Valley Institute of Research - Fort Worth

Fort Worth, Texas, United States

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.