Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
NCT ID: NCT06354660
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2024-04-10
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Retatrutide Dose Level 1
Participants will receive retatrutide administered subcutaneously (SC).
Retatrutide
Administered SC.
Retatrutide Dose Level 2
Participants will receive retatrutide administered SC.
Retatrutide
Administered SC.
Retatrutide Dose Level 3
Participants will receive retatrutide administered SC.
Retatrutide
Administered SC.
Placebo
Participants will receive placebo administered SC.
Placebo
Administered SC.
Interventions
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Retatrutide
Administered SC.
Placebo
Administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c ≥ 7.0% to ≤ 9.5%
* Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
* Are of stable weight for at least 90 days prior to screening
* Have a Body Mass Index (BMI) ≥ 23.0 kilograms per meter squared (kg/m\^2)
Exclusion Criteria
* 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) \<15 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Tucson Clinical Research Institute
Tucson, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Ark Clinical Research
Long Beach, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Ezy Medical Research
Miami, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Trinity Research Centers
Marietta, Georgia, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Boeson Research MSO
Missoula, Montana, United States
NJ MedCare & NJ Heart
Linden, New Jersey, United States
Accellacare - Wilmington - 1917 Tradd Court
Wilmington, North Carolina, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Delricht Research - Tobias Gadson Boulevard - Charleston
Charleston, South Carolina, United States
Lifedoc Research - Lenox Park Drive
Memphis, Tennessee, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Prime Revival Research Institute, LLC
Flower Mound, Texas, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
MultiCare Rockwood Cheney Clinic
Cheney, Washington, United States
Eastside Research Associates
Redmond, Washington, United States
All India Institute of Medical Sciences
Raipur, Chhattisgarh, India
Gujarat Endocrin Pvt Ltd
Ahmedabad, Gujarat, India
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
Victoria Hospital, Bangalore Medical College And Research Institute
Bangalore, Karnataka, India
Government Medical College - Kozhikode
Kozhikode, Kerala, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India
Eternal Heart Care Center and Research Institute
Jaipur, Rajasthan, India
Brij Medical Centre Private Limited
Kanpur, Uttar Pradesh, India
Grupo Ollin Care
Pachuca, Hidalgo, Mexico
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, Mexico
Clínica García Flores SC
Monterrey, Nuevo León, Mexico
Centro de investigación y control metabólico
San Nicolás de los Garza, Nuevo León, Mexico
EME RED Hospitalaria
Mérida, Yucatán, Mexico
Medical Care and Research SA de CV
Mérida, Yucatán, Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
Dorado Medical Complex
Dorado, , Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
Countries
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Related Links
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Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
Other Identifiers
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J1I-MC-GZBY
Identifier Type: OTHER
Identifier Source: secondary_id
18804
Identifier Type: -
Identifier Source: org_study_id
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