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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

NCT06354660•Eli Lilly and Company

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (48)

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

Key Dates

Start Date

April 10, 2024

Primary Completion Date

January 22, 2026

Completion Date

February 20, 2026

Last Updated

March 5, 2026

Enrollment

537

ACTUAL participants

Conditions

Diabetes Type 2

Interventions

Retatrutide

DRUG

Placebo

DRUG

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NCT07374705

Diabetes Type 2Diabetes Type 1

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RECRUITINGNA

Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

NCT05912647

DiabetesDiabetes Type 2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Disentangling the Effect of Brain Insulin Resistance on Brain Health

Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

Healthy Living Anson Study

Exploration of Health Literacy in Diabetes in Reunion Island and France