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Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Plain-language guide to NCT06260722: phase 3 randomized trial of Retatrutide and Semaglutide, 1250 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06260722
Phase
phase 3
Status
active, not recruiting
Start
2024-02-21
Completion (planned or actual)
2026-08-27
Participants
1250 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Diabetes Mellitus, Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Retatrutide and Semaglutide.

The study will last about 26 months and may include up to 24 visits.

It had three arms (groups): one (experimental), one (experimental) and Semaglutide (active comparator).

Participants will receive retatrutide administered subcutaneously (SC).

Participants will receive retatrutide administered SC.

Participants will receive semaglutide administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1250 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.

Examples of who could join: Have Type 2 Diabetes (T2D). Have been on a stable diabetes treatment consisting of metformin a set amount with or without SGLT2i during 90 days prior to screening. Are of stable weight for at least 90 days prior to screening. Have a Body Mass Index (BMI) ≥ 25.0 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

The set-up was randomized, parallel-group and open-label.

Because people in this Retatrutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Retatrutide study: the participants and staff both knew the treatment.

It started in 2024-02-21 with completion listed for 2026-08-27.

It ran at 77 sites in United States (38), Argentina (15), Canada (12), Mexico (10) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) (time frame: Baseline, Week 80).

It also tracked 12 secondary outcomes, for example Change from Baseline in HbA1c (%), 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 and Semaglutide in 1250 people.

With 1250 participants it is a large trial for this field.

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 and the Semaglutide compound page, all human trials.

Our Notes on the Compounds

Retatrutide: A single-molecule triple agonist (GLP-1, GIP and glucagon receptors).

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.