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)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06260722
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose Level 2 Retatrutide Participants will receive retatrutide administered SC. Semaglutide Semaglutide Participants will receive semaglutide administered SC. Retatrutide Dose Level 1 Retatrutide Participants will receive retatrutide administered subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) (%) Baseline, Week 80
- Secondary Outcome Measures
Name Time Method Change from Baseline in HbA1c (%) Baseline, Week 80 Percentage of Participants Who Achieve HbA1c ≤ 6.5% Week 80 Percentage of Participants Who Achieve HbA1c < 5.7% Week 80 Percent Change from Baseline in Body Weight Week 80 Change from Baseline in Body Weight Baseline, Week 80 Percentage of Participants Who Achieve Weight Reduction of ≥ 5% Week 80 Percentage of Participants Who Achieve Weight Reduction of ≥ 10% Week 80 Percentage of Participants Who Achieve Weight Reduction of ≥ 15% Week 80 Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction Week 80 Percent Change from Baseline in Triglycerides Week 80 Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol Week 80 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80
Trial Locations
- Locations (77)
University of Alabama - Department of Nutrition Sciences
🇺🇸Birmingham, Alabama, United States
Neighborhood Healthcare Institute of Health
🇺🇸Escondido, California, United States
Long Beach Research Institute
🇺🇸Long Beach, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
Central States Research
🇺🇸Tulsa, Oklahoma, United States
The Corvallis Clinic, P.C.
🇺🇸Corvallis, Oregon, United States
Valley Institute of Research - Fort Worth
🇺🇸Fort Worth, Texas, United States
Texas Valley Clinical Research
🇺🇸Weslaco, Texas, United States
Alberta Diabetes Institute
🇨🇦Edmonton, Alberta, Canada
Centricity Research Brampton Endocrinology
🇨🇦Brampton, Ontario, Canada
Palm Research Center Sunset
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
IMA Clinical Research West Virginia
🇺🇸Morgantown, West Virginia, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
South Broward Research
🇺🇸Miramar, Florida, United States
Herman Clinical Research
🇺🇸Suwanee, Georgia, United States
Brigham and Women's Hospital Diabetes Program
🇺🇸Boston, Massachusetts, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
CARE - Centro de Alergia y Enfermedades Respiratorias
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Stat Research S.A.
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Deaconess Clinic - Gateway Health Center
🇺🇸Newburgh, Indiana, United States
IMA Clinical Research Monroe - Armand
🇺🇸Monroe, Louisiana, United States
MedStar Health Research Institute (MedStar Physician Based Research Network)
🇺🇸Hyattsville, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
NYC Research INC
🇺🇸Long Island City, New York, United States
Remington Davis Clinical Research
🇺🇸Columbus, Ohio, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norman, Oklahoma, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Medrasa Clinical Research
🇺🇸Wylie, Texas, United States
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Clínicas Baigorria
🇦🇷Granadero Baigorria, Santa Fe, Argentina
University of Calgary - Clinical Trials Unit
🇨🇦Calgary, Alberta, Canada
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Central Washington Health Services Association d/b/a Confluence Health
🇺🇸Wenatchee, Washington, United States
CEMEDIAB
🇦🇷C.a.b.a., Ciudad Autónoma De Buenos Aires, Argentina
Instituto Centenario
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Privado San Vicente Diabetes
🇦🇷Cordoba, Córdoba, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
🇦🇷Godoy Cruz, Mendoza, Argentina
Fundación Respirar
🇦🇷Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro Diabetológico Dr. Waitman
🇦🇷Córdoba, Argentina
Winterberry Research Inc.
🇨🇦Hamilton, Ontario, Canada
The Wharton Medical Clinic Clinical Trials Inc
🇨🇦Hamilton, Ontario, Canada
Hamilton Medical Research Group
🇨🇦Hamilton, Ontario, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Prime Health Clinical Research
🇨🇦Toronto, Ontario, Canada
Maple Leaf Research
🇨🇦Toronto, Ontario, Canada
Private Practice - Dr. Nigel Jagan
🇨🇦Whitby, Ontario, Canada
9109-0126 Quebec Inc.
🇨🇦Montreal, Quebec, Canada
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Hospital de Jésus, I.A.P.
🇲🇽Mexico City, Distrito Federal, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
🇲🇽Mexico City, Distrito Federal, Mexico
Diseno y Planeacion en Investigacion Medica
🇲🇽Guadalajara, Jalisco, Mexico
Instituto de Diabetes, Obesidad y Nutricion
🇲🇽Cuernavaca, Morelos, Mexico
Cardiolink Clin Trials
🇲🇽Monterrey, Nuevo León, Mexico
Clínica García Flores SC
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Enclifar Ensayos Clínicos Farmacológicos Sc
🇲🇽Chihuahua, Mexico
Instituto Veracruzano en Investigación Clínica S.C.
🇲🇽Veracruz, Mexico
Advanced Clinical Research, LLC
🇵🇷Bayamón, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico