Back to Semaglutide research
semaglutide glp 1 agonist rct 2025-08-31 ClinicalTrials

RAY1225 vs. Semaglutide: New Phase 3 Trial for Type 2 Diabetes

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

Background

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by high blood sugar levels. While oral antidiabetic drugs are foundational, many patients require additional therapies to achieve optimal glycemic control and prevent complications. This study aims to compare the efficacy and safety of a novel drug, RAY1225, against the established GLP-1 receptor agonist semaglutide as an add-on therapy for T2DM patients already on oral medications.

Study Design

Population
600 patients with Type 2 Diabetes Mellitus who require additional glycemic control beyond oral medications.
Intervention
RAY1225 at 6 mg and 9 mg doses, route and duration not specified beyond 36 weeks.
Comparator
Semaglutide, dose and route not specified, for 36 weeks.
Outcome
Change from baseline in Hemoglobin A1c (HbA1c) at the 36-week mark.

Results

As this study is currently "NOT_YET_RECRUITING," there are no findings to report yet. However, the primary objective is to evaluate the comparative efficacy of RAY1225 against semaglutide in improving glycemic control. The study will specifically measure the change from baseline in Hemoglobin A1c (HbA1c), a key marker of long-term blood sugar control, at the 36-week mark for both 6 mg and 9 mg RAY1225 doses. The central goal is to determine if RAY1225 can achieve a statistically significant and clinically meaningful reduction in HbA1c levels compared to semaglutide in 600 participants. This trial will provide crucial data on the relative performance of these two treatments.

Why It Matters

If successful, this Phase 3 trial could introduce a new, potentially effective treatment option for Type 2 Diabetes patients who require additional glycemic control beyond oral medications. A positive outcome could lead to regulatory approval for RAY1225, offering an alternative to existing GLP-1 receptor agonists like semaglutide with a potentially less frequent dosing schedule. This study represents a critical step towards expanding therapeutic choices and improving patient outcomes in T2DM, with an estimated completion date in 2026.


semaglutide glp 1 agonist glp-1r dose mentioned
Source: clinicaltrials:NCT07139548 · Ingested 2026-04-28 · Digest: gemini-2.5-flash