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)
- Status
- CompletedResults none
- Why it is watched
- population of special interest (non-obese / healthy / non-diabetic)
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥23 required; non-obese participants included; conditions: Diabetes Type 2
- Interventions
- Retatrutide; Placebo
- Conditions
- Diabetes Type 2
- Phase and size
- Phase 3 · 537 participants
- Dates
- Start 2024-04-10
Primary completion 2026-01-22 - Sponsor
- Eli Lilly and Company (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change from Baseline in Hemoglobin A1c (HbA1c) (%)Baseline, Week 40
Published results in the collection
- Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trialRandomized trial · 2026 · Study tier 2 · Different population · Benefit · Industry funded
02Eligibility
Who can take part
Inclusion Criteria: * 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) 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) \<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.
03Change log
Registry changes
No changes recorded since the trial was added.