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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Type 2

In brief

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.

Key facts

Study ID

NCT06354660

Run by

Eli Lilly and Company

People needed

537

Starts

2024-04-10

Expected to finish

2026-02-20

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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) <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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.