Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

What Was Tested

In this phase 3 trial, researchers set out to test Retatrutide.

The study will last about 14 months and may include up to 22 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

The registry lists 320 planned participants were the target.

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.

The full record lists 8 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 2024-03-15 with completion listed for 2026-10.

It ran at 76 sites in United States (28), Argentina (18), United Kingdom (9), Brazil (7), Israel (7) and Mexico (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in Hemoglobin A1c (HbA1c) (%) (time frame: Baseline, Week 52).

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 Non-HDL Cholesterol, Percent Change from Baseline in Triglycerides 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 320 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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