Clinical trial NCT06260722: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Incretins
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-02-15
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%)
timeFrame: Baseline, Week 80
Secondary outcomes:
measure: Change from Baseline in HbA1c (%)
timeFrame: Baseline, Week 80
measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5%
timeFrame: Week 80
measure: Percentage of Participants Who Achieve HbA1c < 5.7%
timeFrame: Week 80
measure: Percent Change from Baseline in Body Weight
timeFrame: Week 80
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 80
measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
timeFrame: Week 80
measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
timeFrame: Week 80
measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
timeFrame: Week 80
measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
timeFrame: Week 80
measure: Percent Change from Baseline in Triglycerides
timeFrame: Week 80
measure: Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol
timeFrame: Week 80
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 80
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Department of Nutrition Sciences
state: Alabama
city: Escondido
country: United States
facility: Neighborhood Healthcare Institute of Health
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: Miramar
country: United States
facility: South Broward Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Suwanee
country: United States
facility: Herman Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center
state: Indiana
city: Monroe
country: United States
facility: IMA Clinical Research Monroe - Armand
state: Louisiana
city: Hyattsville
country: United States
facility: MedStar Health Research Institute (MedStar Physician Based Research Network)
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital Diabetes Program
state: Massachusetts
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Long Island City
country: United States
facility: NYC Research INC
state: New York
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Columbus
country: United States
facility: Remington Davis Clinical Research
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research - Fort Worth
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Wylie
country: United States
facility: Medrasa Clinical Research
state: Texas
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
state: Washington
city: Morgantown
country: United States
facility: IMA Clinical Research West Virginia
state: West Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CARE - Centro de Alergia y Enfermedades Respiratorias
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Stat Research S.A.
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: C.a.b.a.
country: Argentina
facility: CEMEDIAB
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Instituto Centenario
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Cordoba
country: Argentina
facility: Centro Medico Privado San Vicente Diabetes
state: Córdoba
city: Godoy Cruz
country: Argentina
facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
state: Mendoza
city: Granadero Baigorria
country: Argentina
facility: Centro de Investigaciones Clínicas Baigorria
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Córdoba
country: Argentina
facility: Centro Diabetológico Dr. Waitman
city: Calgary
country: Canada
facility: University of Calgary - Clinical Trials Unit
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Diabetes Institute
state: Alberta
city: Brampton
country: Canada
facility: Centricity Research Brampton Endocrinology
state: Ontario
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Hamilton
country: Canada
facility: Winterberry Research Inc.
state: Ontario
city: Hamilton
country: Canada
facility: The Wharton Medical Clinic Clinical Trials Inc
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Toronto
country: Canada
facility: Prime Health Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research
state: Ontario
city: Whitby
country: Canada
facility: Private Practice - Dr. Nigel Jagan
state: Ontario
city: Montreal
country: Canada
facility: 9109-0126 Quebec Inc.
state: Quebec
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Hospital de Jésus, I.A.P.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes, Obesidad y Nutricion
state: Morelos
city: Monterrey
country: Mexico
facility: Cardiolink Clin Trials
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Enclifar Ensayos Clínicos Farmacológicos Sc
city: Veracruz
country: Mexico
facility: Instituto Veracruzano en Investigación Clínica S.C.
city: Bayamón
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: