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A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes

Plain-language guide to NCT07139548: phase 3 randomized trial of Semaglutide, 600 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07139548
Phase
phase 3
Status
not yet recruiting
Start
2025-08-31
Completion (planned or actual)
2026-12-01
Participants
600 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
T2DM
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 600 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 been diagnosed with type 2 diabetes mellitus (T2DM). Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;; history of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;.

How the Study Was Run

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

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

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-08-31 with completion listed for 2026-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) ([amount hidden]).

It also tracked 5 secondary outcomes, for example Mean change in fasting serum glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 600 people.

With 600 participants it is a large trial for this field.

Its status is not yet 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.