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NCT06260722 | ACTIVE NOT RECRUITING | Diabetes Mellitus, Type 2

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)
Sponsor:

Eli Lilly and Company

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.

Condition or disease

Diabetes Mellitus, Type 2

Intervention/treatment

Retatrutide

Semaglutide

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1250 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Actual Study Start Date : 2024-02-21
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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)

Location Details

NCT06260722

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Albama

University of Alabama - Department of Nutrition Sciences

Birmingham, Albama, United States, 35294

Not yet recruiting

United States, California

Neighborhood Healthcare Institute of Health

Escondido, California, United States, 92025

Not yet recruiting

United States, California

Long Beach Research Institute

Long Beach, California, United States, 90805

Not yet recruiting

United States, California

Valley Clinical Trials, Inc.

Northridge, California, United States, 91325

Not yet recruiting

United States, California

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, United States, 91730

Not yet recruiting

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Not yet recruiting

United States, Florida

Arrow Clinical Trials

Daytona Beach, Florida, United States, 32117

Not yet recruiting

United States, Florida

New Age Medical Research Corporation

Miami, Florida, United States, 33186

Not yet recruiting

United States, Florida

South Broward Research

Miramar, Florida, United States, 33027

Not yet recruiting

United States, Florida

Clinical Research of Central Florida

Winter Haven, Florida, United States, 33880

Not yet recruiting

United States, Georgia

Herman Clinical Research

Suwanee, Georgia, United States, 30024

Not yet recruiting

United States, Georgia

North Georgia Clinical Research

Woodstock, Georgia, United States, 30189

Not yet recruiting

United States, Hawaii

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States, 96817

Not yet recruiting

United States, Idaho

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States, 83404

Not yet recruiting

United States, Indiana

Deaconess Clinic - Gateway Health Center

Newburgh, Indiana, United States, 47630

Not yet recruiting

United States, Louisiana

IMA Clinical Research Monroe - Armand

Monroe, Louisiana, United States, 71201

Not yet recruiting

United States, Maryland

MedStar Health Research Institute (MedStar Physician Based Research Network)

Hyattsville, Maryland, United States, 20782

Not yet recruiting

United States, Massachusetts

Brigham and Women's Hospital Diabetes Program

Boston, Massachusetts, United States, 02115

Not yet recruiting

United States, Massachusetts

NECCR PrimaCare Research

Fall River, Massachusetts, United States, 02721

Not yet recruiting

United States, Road cancer

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Road cancer, United States, 48098

Not yet recruiting

United States, Nevada

Palm Research Center Tenaya

Las Vegas, Nevada, United States, 89128

Not yet recruiting

United States, Nevada

Palm Research Center Sunset

Las Vegas, Nevada, United States, 89148

Not yet recruiting

United States, New York

NYC Research INC

Long Island City, New York, United States, 11106

Not yet recruiting

United States, North Carolina

Medication Management

Greensboro, North Carolina, United States, 27405

Not yet recruiting

United States, Ohio

Remington Davis Clinical Research

Columbus, Ohio, United States, 43215

Not yet recruiting

United States, Oklahola

Alliance for Multispecialty Research, LLC

Norman, Okholohan, United States, 73069

Not yet recruiting

United States, Oklahola

Central States Research

Tulsa, Okholohan, United States, 74136

Not yet recruiting

United States, Oregon

The Corvallis Clinic, P.C.

Corvallis, Oregon, United States, 97330

Not yet recruiting

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Not yet recruiting

United States, Texas

Velocity Clinical Research, Dallas

Dallas, Texas, United States, 75230

Not yet recruiting

United States, Texas

Valley Institute of Research - Fort Worth

Fort Worth, Texas, United States, 76164

Not yet recruiting

United States, Texas

Juno Research

Houston, Texas, United States, 77040

Not yet recruiting

United States, Texas

Southern Endocrinology Associates

Mesquite, Texas, United States, 75149

Not yet recruiting

United States, Texas

Consano Clinical Research, LLC

Carcino, Texas, United States, 78231

Not yet recruiting

United States, Texas

Texas Valley Clinical Research

Weslaco, Texas, United States, 78596

Not yet recruiting

United States, Texas

Clinical Medrase Research

Wylie, Texas, United States, 75098

Not yet recruiting

United States, Washington

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

Wenatchee, Washington, United States, 98801

Not yet recruiting

United States, West Virginia

IMA Clinical Research West Virginia

Morgantown, West Virginia, United States, 26505

Not yet recruiting

Argentina, Buenos Aires

Care - Alfe Center and Respiratory Diseases

Autonomous City of Buenos Aires, Buenos Aires, Argentina, 1414

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

Stat Research S.A.

Buenos Aires, Autonomous City of Buenos Aires, Argentina, Q1023 August

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

CIPREC

Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1061AAS

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

Viamonte Medical Center

Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1120AAC

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

Mautalen Health and Research

Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1128Aaf

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

CEMEDIAB

C.a.b.a., Autonomous City of Buenos Aires, Argentina, C1205aao

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

Centennial Institute

CABA, Autonomous City of Buenos Aires, Argentina, 1204

Not yet recruiting

Argentina, Autonomous City of Buenos Aires

Medical Center Dr. Laura Maffei- Investigation Clinic Applied

Autonomous City of Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1425AGC

Not yet recruiting

Argentina, Córdoba

Private Medical Center San Vicente Diabetes

Cordoba, Córdoba, Argentina, 5006

Not yet recruiting

Argentina, Mendoza

Cipadi - Integral Center for Diabetes Prevention and Attention

Godoy Cruz, Mendoza, Argentina, 5501

Not yet recruiting

Argentina, Santa Fe

Baigorria Clinical Research Center

Baigorria grenadier, Santa Fe, Argentina, 2152

Not yet recruiting

Argentina, Santa Fe

Rosario Clinic Research Institute

Rosario, Santa Fe, Argentina, S2000CVD

Not yet recruiting

Argentina,

Breathe Foundation

Buenos Aires, Argentina, C1426ABP

Not yet recruiting

Argentina,

Metabolic Research Center (CINME)

Autonomous City of Buenos Aires, Argentina, C1056ABI

Not yet recruiting

Argentina,

Dr. Waitman Diabetological Center

Córdoba, Argentina, 5000

Not yet recruiting

Canada, Alberta

University of Calgary - Clinical Trials Unit

Calgary, Alberta, Canada, It brings out

Not yet recruiting

Canada, Alberta

Alberta Diabetes Institute

Edmonton, Alberta, Canada, T6G 2E1

Not yet recruiting

Canada, Ontario

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada, L6S 0C6

Not yet recruiting

Canada, Ontario

Aggarwal and Associates Limited

Brampton, Ontario, Canada, L6T 0G1

Not yet recruiting

Canada, Ontario

Winterberry Research Inc.

Hamilton, Ontario, Canada, L8j 0b6

Not yet recruiting

Canada, Ontario

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Ontario, Canada, L8L 5G8

Not yet recruiting

Canada, Ontario

Hamilton Medical Research Group

Hamilton, Ontario, Canada, L8l5g4

Not yet recruiting

Canada, Ontario

Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada, N7T 4X3

Not yet recruiting

Canada, Ontario

Prime Health Clinical Research

Toronto, Ontario, Canada, M4S 1Y2

Not yet recruiting

Canada, Ontario

Maple Leaf Research

Toronto, Ontario, Canada, M5G 1K2

Not yet recruiting

Canada, Ontario

Private Practice - Dr. Nigel Jagan

Whitby, Ontario, Canada, L1N 2L1

Not yet recruiting

Canada, Quebec

9109-0126 Quebec Inc.

Montreal, Quebec, Canada, H4N 2W2

Not yet recruiting

Mexico, Federal district

RM Pharma Specialists

Mexico City, Federal District, Mexico, 03100

Not yet recruiting

Mexico, Federal district

Jésus Hospital, I.A.P.

Mexico City, Federal District, Mexico, 06090

Not yet recruiting

Mexico, Federal district

Center specialized in diabetes, obesity and prevention of cardiovascular diseases

Mexico City, Federal District, Mexico, 11650

Not yet recruiting

Mexico, Jalisco

DESIGN AND PLANNING IN MEDICAL RESEARCH

Guadalajara, Jalisco, Mexico, 44130

Not yet recruiting

Mexico, Morelos

Institute of Diabetes, Obesity and Nutrition

Cuernavaca, Morelos, Mexico, 62250

Not yet recruiting

Mexico, Nuevo León

Cardiolink Clin Trials

Monterrey, Nuevo León, Mexico, 64060

Not yet recruiting

Mexico, Nuevo León

García Flores SC Clinic

Monterrey, Nuevo León, Mexico, 64610

Not yet recruiting

Mexico, Nuevo León

University Hospital "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico, 66460

Not yet recruiting

Mexico,

Enlifar Pharmacological clinical trials SC

Chihuahua, Mexico, 31110

Not yet recruiting

Mexico,

Instituto Veracruzano in Research Clinical S.C.

Veracruz, Mexico, 91851

Not yet recruiting

Puerto Rico,

Advanced Clinical Research, LLC

Bayamón, Puerto Rico, 00959

Not yet recruiting

Puerto Rico,

GCM Medical Group, PSC - Hato Rey Site

San Juan, Puerto Rico, 00917