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)

What Was Tested

This registered phase 3 trial tested Retatrutide.

The study will last about 11 months and may include up to 11 visits.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

Participants will receive retatrutide administered subcutaneously (SC).

Participants will receive retatrutide administered SC.

Participants will receive retatrutide administered SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 537 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have Type 2 Diabetes (T2D). 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).

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Retatrutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Retatrutide.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-10 with completion listed for 2026-01-22.

It ran at 48 sites in United States (29), Mexico (9), India (8) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in Hemoglobin A1c (HbA1c) (%) (time frame: Baseline, Week 40).

It also tracked 13 secondary outcomes, for example Change from Baseline in Fasting Serum Glucose, Percent Change from Baseline in Body Weight, Change from Baseline in Body Weight, Percent Change from Baseline in Triglycerides, Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol and Change from Baseline in Systolic Blood Pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Retatrutide in 537 people.

With 537 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Retatrutide compound page, all human trials.