A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes

ClinicalTrials24 Aug 2025·Phase 3● 5/10i

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes

Guangdong Raynovent Biotech Co., Ltd

RAY1225, a GLP-1 receptor agonist from Guangdong Raynovent Biotech, is being tested head-to-head against semaglutide as add-on therapy to oral antidiabetic drugs in adults with type 2 diabetes. The open-label phase 3 trial targets 600 participants with expected completion in December 2026, measuring HbA1c reduction as the primary endpoint. This represents another Chinese biotech company attempting to challenge Novo Nordisk's semaglutide dominance in the established GLP-1 diabetes market. The direct comparator design suggests confidence in differentiation, though the open-label format may limit regulatory acceptance versus blinded superiority trials.

Strategic signal

This head-to-head design positions Raynovent for direct efficacy claims against Ozempic in diabetes, a strategy that could resonate with cost-conscious payers seeking biosimilar alternatives. Chinese regulators increasingly favor local innovation over foreign competitors, potentially accelerating domestic approval while creating pricing pressure for Novo Nordisk in Asia. The open-label format may complicate FDA acceptance but aligns with Chinese regulatory preferences for pragmatic trial designs.

GLP-1Type 2 diabetesDrug comparisonsGuangdong Raynovent Biotech Novo Nordisk

Original Abstract

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. | Condition(s): T2DM | Primary endpoint(s): Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg) | Enrollment: 600 (estimated) | Phase: Phase 3 | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Expected completion: 2026-12-01 | Status: Not Yet Recruiting | Last update: 2025-08-24

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