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)

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260722
• Other study ID #: 18805
• Secondary ID: J1I-MC-GZBZ
• Status: Recruiting
• Phase: Phase 3
• Start date: February 21, 2024
• Est. completion date: March 30, 2027

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: March 30, 2027
• Est. primary completion date: December 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Retatrutide
Administered SC.
• Semaglutide
Administered SC.

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Fundación Respirar	Buenos Aires
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Stat Research S.A.	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CEMEDIAB	C.a.b.a.	Ciudad Autónoma De Buenos Aires
Argentina	Instituto Centenario	Caba	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	CARE - Centro de Alergia y Enfermedades Respiratorias	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aires
Argentina	Centro Medico Privado San Vicente Diabetes	Cordoba	Córdoba
Argentina	Centro Diabetológico Dr. Waitman	Córdoba
Argentina	CIPADI - Centro Integral de Prevencion y Atencion en Diabetes	Godoy Cruz	Mendoza
Argentina	Centro de Investigaciones Clínicas Baigorria	Granadero Baigorria	Santa Fe
Argentina	Instituto de Investigaciones Clinicas Rosario	Rosario	Santa Fe
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	University of Calgary - Clinical Trials Unit	Calgary	Alberta
Canada	Alberta Diabetes Institute	Edmonton	Alberta
Canada	Dr. Steven V. Zizzo Medicine Professional Corporation	Hamilton	Ontario
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	Wharton Medical Clinic	Hamilton	Ontario
Canada	9109-0126 Quebec Inc.	Montreal	Quebec
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Maple Leaf Research	Toronto	Ontario
Canada	Prime Health Clinical Research	Toronto	Ontario
Canada	Private Practice - Dr. Nigel Jagan	Whitby	Ontario
Mexico	Enclifar Ensayos Clínicos Farmacológicos Sc	Chihuahua
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Diseno y Planeacion en Investigacion Medica	Guadalajara	Jalisco
Mexico	Private Practice - Dr. Arechavaleta Granell Maria del Rosario	Guadalajara	Jalisco
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	Hospital de Jésus, I.A.P.	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Cardiolink Clin Trials	Monterrey	Nuevo León
Mexico	Clínica García Flores SC	Monterrey	Nuevo León
Mexico	Instituto Veracruzano en Investigación Clínica S.C.	Veracruz
Puerto Rico	Advanced Clinical Research, LLC	Bayamón
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	University of Alabama - Department of Nutrition Sciences	Birmingham	Alabama
United States	Brigham and Women's Hospital Diabetes Program	Boston	Massachusetts
United States	Remington Davis Clinical Research	Columbus	Ohio
United States	The Corvallis Clinic, P.C.	Corvallis	Oregon
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Arrow Clinical Trials	Daytona Beach	Florida
United States	Neighborhood Healthcare Institute of Health	Escondido	California
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	Valley Institute of Research - Fort Worth	Fort Worth	Texas
United States	Medication Management	Greensboro	North Carolina
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Juno Research	Houston	Texas
United States	MedStar Health Research Institute (MedStar Physician Based Research Network)	Hyattsville	Maryland
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Long Beach Research Institute	Long Beach	California
United States	NYC Research INC	Long Island City	New York
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	New Age Medical Research Corporation	Miami	Florida
United States	South Broward Research	Miramar	Florida
United States	IMA Clinical Research Monroe - Armand	Monroe	Louisiana
United States	Exemplar Research	Morgantown	West Virginia
United States	Deaconess Clinic - Gateway Health Center	Newburgh	Indiana
United States	Intend Research, LLC	Norman	Oklahoma
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Herman Clinical Research	Suwanee	Georgia
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	Central States Research	Tulsa	Oklahoma
United States	Central Washington Health Services Association d/b/a Confluence Health	Wenatchee	Washington
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	Medrasa Clinical Research	Wylie	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c) (%)		Baseline, Week 80
Secondary	Change from Baseline in HbA1c (%)		Baseline, Week 80
Secondary	Percentage of Participants Who Achieve HbA1c = 6.5%		Week 80
Secondary	Percentage of Participants Who Achieve HbA1c < 5.7%		Week 80
Secondary	Percent Change from Baseline in Body Weight		Week 80
Secondary	Change from Baseline in Body Weight		Baseline, Week 80
Secondary	Percentage of Participants Who Achieve Weight Reduction of = 5%		Week 80
Secondary	Percentage of Participants Who Achieve Weight Reduction of = 10%		Week 80
Secondary	Percentage of Participants Who Achieve Weight Reduction of = 15%		Week 80
Secondary	Percentage of Participants Who Achieve HbA1c = 6.5% and = 10% Weight Reduction		Week 80
Secondary	Percent Change from Baseline in Triglycerides		Week 80
Secondary	Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol		Week 80
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 80

External Links

•   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)