GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

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

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.