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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)

RecruitingPhase 3
76 recruiting sites
Start: Feb 8, 2024
NCTNCT06260722

This trial is currently recruiting participants

76 locations available for registration

Brief Summary

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.

Eligibility

Age Range

18 Years - N/A

Gender

All

Healthy Volunteers

Not Accepted

Detailed Criteria

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.

Conditions

Diabetes Mellitus, Type 2

Interventions

Retatrutide

Administered SC.

DRUG

Semaglutide

Administered SC.

DRUG

Trial Locations

76 locations currently accepting registrations. Choose a recruiting location below to register your interest.

University of Alabama - Department of Nutrition Sciences

Birmingham, Alabama, United States

Recruiting

Neighborhood Healthcare Institute of Health

Escondido, California, United States

Recruiting

Long Beach Research Institute

Long Beach, California, United States

Recruiting

Valley Clinical Trials, Inc.

Northridge, California, United States

Recruiting

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, United States

Recruiting

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Recruiting

Arrow Clinical Trials

Daytona Beach, Florida, United States

Recruiting

New Age Medical Research Corporation

Miami, Florida, United States

Recruiting

South Broward Research

Miramar, Florida, United States

Recruiting

Clinical Research of Central Florida

Winter Haven, Florida, United States

Recruiting

Herman Clinical Research

Suwanee, Georgia, United States

Recruiting

North Georgia Clinical Research

Woodstock, Georgia, United States

Recruiting

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Recruiting

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Recruiting

Deaconess Clinic - Gateway Health Center

Newburgh, Indiana, United States

Recruiting

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, United States

Recruiting

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, United States

Recruiting

Brigham and Women's Hospital Diabetes Program

Boston, Massachusetts, United States

Recruiting

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Recruiting

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Recruiting

Palm Research Center Tenaya

Las Vegas, Nevada, United States

Recruiting

Palm Research Center Sunset

Las Vegas, Nevada, United States

Recruiting

NYC Research INC

Long Island City, New York, United States

Recruiting

Medication Management

Greensboro, North Carolina, United States

Recruiting

Remington Davis Clinical Research

Columbus, Ohio, United States

Recruiting

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Recruiting

Central States Research

Tulsa, Oklahoma, United States

Recruiting

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States

Recruiting

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Recruiting

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Recruiting

Valley Institute of Research - Fort Worth

Fort Worth, Texas, United States

Recruiting

Juno Research

Houston, Texas, United States

Recruiting

Southern Endocrinology Associates

Mesquite, Texas, United States

Recruiting

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Recruiting

Texas Valley Clinical Research

Weslaco, Texas, United States

Recruiting

Medrasa Clinical Research

Wylie, Texas, United States

Recruiting

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

Wenatchee, Washington, United States

Recruiting

IMA Clinical Research West Virginia

Morgantown, West Virginia, United States

Recruiting

CARE - Centro de Alergia y Enfermedades Respiratorias

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Recruiting

Stat Research S.A.

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

CIPREC

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

Centro Médico Viamonte

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

Mautalen Salud e Investigación

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

CEMEDIAB

C.a.b.a., Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

Instituto Centenario

Caba, Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Recruiting

Centro Medico Privado San Vicente Diabetes

Cordoba, Córdoba, Argentina

Recruiting

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza, Argentina

Recruiting

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, Santa Fe, Argentina

Recruiting

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe, Argentina

Recruiting

Fundación Respirar

Buenos Aires, Argentina

Recruiting

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Argentina

Recruiting

Centro Diabetológico Dr. Waitman

Córdoba, Argentina

Recruiting

University of Calgary - Clinical Trials Unit

Calgary, Alberta, Canada

Recruiting

Alberta Diabetes Institute

Edmonton, Alberta, Canada

Recruiting

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Recruiting

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Recruiting

Winterberry Research Inc.

Hamilton, Ontario, Canada

Recruiting

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Ontario, Canada

Recruiting

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Recruiting

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

Recruiting

Prime Health Clinical Research

Toronto, Ontario, Canada

Recruiting

Maple Leaf Research

Toronto, Ontario, Canada

Recruiting

Private Practice - Dr. Nigel Jagan

Whitby, Ontario, Canada

Recruiting

9109-0126 Quebec Inc.

Montreal, Quebec, Canada

Recruiting

RM Pharma Specialists

Mexico City, Distrito Federal, Mexico

Recruiting

Hospital de Jésus, I.A.P.

Mexico City, Distrito Federal, Mexico

Not Yet Recruiting

Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

Mexico City, Distrito Federal, Mexico

Recruiting

Diseno y Planeacion en Investigacion Medica

Guadalajara, Jalisco, Mexico

Recruiting

Private Practice - Dr. Arechavaleta Granell Maria del Rosario

Guadalajara, Jalisco, Mexico

Not Yet Recruiting

Instituto de Diabetes, Obesidad y Nutricion

Cuernavaca, Morelos, Mexico

Recruiting

Cardiolink Clin Trials

Monterrey, Nuevo León, Mexico

Recruiting

Clínica García Flores SC

Monterrey, Nuevo León, Mexico

Recruiting

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Recruiting

Enclifar Ensayos Clínicos Farmacológicos Sc

Chihuahua, Mexico

Recruiting

Instituto Veracruzano en Investigación Clínica S.C.

Veracruz, Mexico

Recruiting

Advanced Clinical Research, LLC

Bayamón, Puerto Rico

Recruiting

GCM Medical Group, PSC - Hato Rey Site

San Juan, Puerto Rico

Recruiting

Sponsor Information

Lead Sponsor

Eli Lilly and Company

Type: INDUSTRY