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A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

Plain-language guide to NCT07662213: phase 3 randomized trial of Semaglutide, 1200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07662213
Phase
phase 3
Status
recruiting participants
Start
2026-07-06
Completion (planned or actual)
2028-05-23
Participants
1200 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Type 2 Diabetes Mellitus
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Semaglutide.

It had two arms (groups): Elecoglipron (experimental) and Semaglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1200 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: Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening. T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s). Body mass index (BMI) of ≥ 23 kg/m2 at screening. Stable body weight (self-reported or documented) for 90 days prior to screening.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: type 1 diabetes mellitus (t1dm), secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma; currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema; history of acute or chronic pancreatitis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2026-07-06 with completion listed for 2028-05-23.

It ran at 210 sites in United States (65), Germany (19), Japan (16), China (15), United Kingdom (12) and Canada (10).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 7 secondary outcomes, for example Percent change from baseline to Week 52 in body weight, Change from baseline to Week 52 in body weight (kg) and Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1200 people.

With 1200 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

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.