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)

NCT ID: NCT06260722

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Retatrutide Dose Level 1

Participants will receive retatrutide administered subcutaneously (SC).

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC.

Retatrutide Dose Level 2

Participants will receive retatrutide administered SC.

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC.

Semaglutide

Participants will receive semaglutide administered SC.

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

Administered SC.

Interventions

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Retatrutide

Administered SC.

Intervention Type DRUG

Semaglutide

Administered SC.

Intervention Type DRUG

Other Intervention Names

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LY3437943

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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University of Alabama - Department of Nutrition Sciences

Birmingham, Alabama, United States

Site Status

Neighborhood Healthcare Institute of Health

Escondido, California, United States

Site Status

Long Beach Research Institute

Long Beach, California, United States

Site Status

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Arrow Clinical Trials

Daytona Beach, Florida, United States

Site Status

New Age Medical Research Corporation

Miami, Florida, United States

Site Status

South Broward Research

Miramar, Florida, United States

Site Status

Clinical Research of Central Florida

Winter Haven, Florida, United States

Site Status

Herman Clinical Research

Suwanee, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Deaconess Clinic - Gateway Health Center

Newburgh, Indiana, United States

Site Status

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, United States

Site Status

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, United States

Site Status

Brigham and Women's Hospital Diabetes Program

Boston, Massachusetts, United States

Site Status

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Site Status

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Site Status

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Site Status

Palm Research Center Sunset

Las Vegas, Nevada, United States

Site Status

NYC Research INC

Long Island City, New York, United States

Site Status

Medication Management

Greensboro, North Carolina, United States

Site Status

Remington Davis Clinical Research

Columbus, Ohio, United States

Site Status

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status

Central States Research

Tulsa, Oklahoma, United States

Site Status

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

Valley Institute of Research - Fort Worth

Fort Worth, Texas, United States

Site Status

Juno Research

Houston, Texas, United States

Site Status

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

Texas Valley Clinical Research

Weslaco, Texas, United States

Site Status

Medrasa Clinical Research

Wylie, Texas, United States

Site Status

Central Washington Health Services Association d/b/a Confluence Health

Wenatchee, Washington, United States

Site Status

IMA Clinical Research West Virginia

Morgantown, West Virginia, United States

Site Status

CARE - Centro de Alergia y Enfermedades Respiratorias

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Stat Research S.A.

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

CEMEDIAB

C.a.b.a., Buenos Aires F.D., Argentina

Site Status

Instituto Centenario

CABA, Buenos Aires F.D., Argentina

Site Status

Centro Medico Privado San Vicente Diabetes

Córdoba, Córdoba Province, Argentina

Site Status

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Site Status

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Santa Fe Province, Argentina

Site Status

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

Site Status

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status

Fundación Respirar

Buenos Aires, , Argentina

Site Status

Centro Diabetológico Dr. Waitman

Córdoba, , Argentina

Site Status

University of Calgary - Clinical Trials Unit

Calgary, Alberta, Canada

Site Status

Alberta Diabetes Institute

Edmonton, Alberta, Canada

Site Status

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Site Status

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Site Status

Winterberry Research Inc.

Hamilton, Ontario, Canada

Site Status

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Ontario, Canada

Site Status

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Site Status

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Site Status

Prime Health Clinical Research

Toronto, Ontario, Canada

Site Status

Maple Leaf Research

Toronto, Ontario, Canada

Site Status

Private Practice - Dr. Nigel Jagan

Whitby, Ontario, Canada

Site Status

9109-0126 Quebec Inc.

Montreal, Quebec, Canada

Site Status

Diseno y Planeacion en Investigacion Medica

Guadalajara, Jalisco, Mexico

Site Status

RM Pharma Specialists

Mexico City, Mexico City, Mexico

Site Status

Hospital de Jésus, I.A.P.

Mexico City, Mexico City, Mexico

Site Status

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

Mexico City, Mexico City, Mexico

Site Status

Instituto de Diabetes, Obesidad y Nutricion

Cuernavaca, Morelos, Mexico

Site Status

Cardiolink Clin Trials

Monterrey, Nuevo León, Mexico

Site Status

Clínica García Flores SC

Monterrey, Nuevo León, Mexico

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Site Status

Enclifar Ensayos Clínicos Farmacológicos Sc

Chihuahua City, , Mexico

Site Status

Instituto Veracruzano en Investigación Clínica S.C.

Veracruz, , Mexico

Site Status

Advanced Clinical Research, LLC

Bayamón, , Puerto Rico

Site Status

GCM Medical Group, PSC - Hato Rey Site

San Juan, , Puerto Rico

Site Status

Countries

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United States Argentina Canada Mexico Puerto Rico

Related Links

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https://trials.lilly.com/en-US/trial/461538

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)

Other Identifiers

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J1I-MC-GZBZ

Identifier Type: OTHER

Identifier Source: secondary_id

18805

Identifier Type: -

Identifier Source: org_study_id

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