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NCT06354660CompletedPhase 3

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)

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

Brief summary (registry, in English)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
537 (actual)
First submitted
3 Apr 2024
Start date
10 Apr 2024
Primary completion date
22 Jan 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT06354660

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 537
  • From 10 Apr 2024 to the primary completion date, 22 Jan 2026
  • 48 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 a prior or planned surgical treatment for obesity
  • Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
  • Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Other illness

  • Have Type 1 Diabetes (T1D)
  • Have New York Heart Association Functional Classification IV congestive heart failure
  • 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
  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2

Lab values

  • 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

Other

  • Have a known clinically significant gastric emptying abnormality
  • Had chronic or acute pancreatitis

Who the study is looking for

  • Have Type 2 Diabetes (T2D)
  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gujarat Endocrin Pvt Ltd
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AhmedabadIndiaUnknown status
Victoria Hospital, Bangalore Medical College And Research Institute
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BangaloreIndiaUnknown status
All India Institute of Medical Sciences
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BhubaneswarIndiaUnknown status
Eternal Heart Care Center and Research Institute
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JaipurIndiaUnknown status
Brij Medical Centre Private Limited
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KanpurIndiaUnknown status
Government Medical College, Kozhikode
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KozhikodeIndiaUnknown status
All India Institute of Medical Sciences
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RaipurIndiaUnknown status
Nirmal Hospital Pvt Ltd.
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SuratIndiaUnknown status
Instituto Jalisciense de Investigacion en Diabetes y Obesidad
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GuadalajaraMexicoUnknown status
Medical Care and Research Sa de Cv
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MéridaMexicoUnknown status
Eme Red Hospitalaria
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MéridaMexicoUnknown status
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Mexico CityMexicoUnknown status
Unidad Biomedica Avanzada Monterrey
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MonterreyMexicoUnknown status
Clínica García Flores SC
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MonterreyMexicoUnknown status
Grupo Ollin Care
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PachucaMexicoUnknown status
Centro de investigación y control metabólico
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San Nicolás de los GarzaMexicoUnknown status
Arké SMO S.A de C.V
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VeracruzMexicoUnknown status
Dorado Medical Complex
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DoradoPuerto RicoUnknown status
Ponce Medical School Foundation Inc.
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PoncePuerto RicoUnknown status
San Fernando Valley Health Institute
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Canoga ParkUnited StatesUnknown status
Delricht Research - Tobias Gadson Boulevard - Charleston
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CharlestonUnited StatesUnknown status
MultiCare Rockwood Cheney Clinic
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CheneyUnited StatesUnknown status
Clinical Research Professionals
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ChesterfieldUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Providence Health Partners-Center for Clinical Research
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DaytonUnited StatesUnknown status
NECCR PrimaCare Research
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Fall RiverUnited StatesUnknown status
Northeast Research Institute (NERI)
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Fleming IslandUnited StatesUnknown status
Prime Revival Research Institute, LLC
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Flower MoundUnited StatesUnknown status
Valley Institute of Research - Fort Worth
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Fort WorthUnited StatesUnknown status
NJ MedCare & NJ Heart
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LindenUnited StatesUnknown status
Ark Clinical Research
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Long BeachUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Trinity Research Centers
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MariettaUnited StatesUnknown status
Lifedoc Research - Lenox Park Drive
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MemphisUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
Ezy Medical Research
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MiamiUnited StatesUnknown status
Boeson Research MSO
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MissoulaUnited StatesUnknown status
Clinical Research Associates, Inc.
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NashvilleUnited StatesUnknown status
Clinical Research of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Eastside Research Associates
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RedmondUnited StatesUnknown status
Scottsdale Clinical Trials
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ScottsdaleUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Cotton O'Neil Clinical Research Center
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TopekaUnited StatesUnknown status
Tucson Clinical Research Institute
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TucsonUnited StatesUnknown status
Preferred Primary Care Physicians
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UniontownUnited StatesUnknown status
Texas Valley Clinical Research
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WeslacoUnited StatesUnknown status
Accellacare - Wilmington - 1917 Tradd Court
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WilmingtonUnited StatesUnknown status
Clinical Research of Central Florida
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Winter HavenUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.