Raynovent Initiates Phase III Trials for GLP-1R/GIPR Dual Agonist, Challenging Semaglutide
Publish Time:
2025-08-08
On July 30, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that Raynovent Biotech's subsidiary, Raynovent registered a Phase III clinical trial of RAY1225 injection in combination therapy for type 2 diabetes (RAY1225-24-13, Registration No.: CTR20252996) 。
This is a multi-center, randomized, open-label, semaglutide injection-controlled Phase III clinical trial designed to evaluate the safety and efficacy of RAY1225 in patients with type 2 diabetes whose blood glucose is poorly controlled after oral hypoglycemic drugs.
The study plans to enroll 600 subjects , randomly assigned to receive RAY1225 subcutaneous injection every two weeks and Semaglutide subcutaneous injection once a week treatment for 52 weeks. The primary endpoint is the change in HbA1c from baseline at 36 weeks of treatment, and the secondary endpoints include the change in HbA1c from baseline at each time point, the change in HbA1c from baseline at each time point, adverse events, laboratory tests, vital signs, electrocardiogram, and hypoglycemic events.
RAY1225 is an independently developed by ZS Raynovent GLP-1/GIP dual receptor agonist . RAY1225 regulates human metabolism through multiple mechanisms of action such as promoting insulin secretion in a glucose-dependent manner and delaying gastric emptying, thereby achieving the effects of lowering blood sugar, reducing weight, and reducing peripheral insulin resistance. and is expected to be used for the treatment of various metabolic diseases such as lowering blood sugar, weight loss, and metabolic syndrome.
In June of this year, ZS Raynovent will announce the latest results of the Phase II REBUILDING-1 study of RAY1225 in the treatment of overweight/obesity at the American Diabetes Association in the form of a poster.
The study included Part A lower-dose parallel study and Part B higher-dose dose escalation and expansion study, and a total of 132 subjects were included. At baseline, the average weight of the subjects was 91.07 kg, and the average BMI was 32.33 kg/m2。 The primary endpoint was at week 24 Percentage change in body weight from baseline.
The results showed that at week 24, the percentage of average weight change in the RAY1225 group was: 10.05% decrease in the 3mg group, 12.98% decrease in the 6mg group, 15.05% decrease in the 9mg group, and 3.55% decrease in the placebo group (P<0.001) Approximately 73.2% to 95.1% of subjects in the RAY1225 group experienced a weight loss of ≥5%, while only 30.0% in the placebo group (P<0.05) 。
In addition, RAY1225 is also beneficial for improving cardiometabolic indicators. The most common adverse events (AEs) of RAY1225 were gastrointestinal reactions, most of which were mild to moderate and mainly occurred during dose escalation. No drug-related serious adverse events occurred.
Insight database shows that in addition to Raynovent, Innovent Biologics (Mazdutide), Gan & Lee Pharmaceuticals (Glepaglutide), Hengrui Pharmaceuticals (HRS9531) and Borui Biologics (BGM0504) have also launched Phase III clinical trials to challenge semaglutide.
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