2026 ADA Oral Presentation | Raynovent RAY1225 Injection Phase II Study Shines: Up to 21.2% Weight Loss at 24 Weeks

On June 7, 2026 (U.S. time), the world's most prestigious academic event in diabetes and metabolism—the 86th Scientific Sessions of the American Diabetes Association (ADA)—grandly opened in New Orleans.Raynovent's self-developed RAY1225, the world's first biweekly full-biased GLP-1/GIP receptor agonist, was presented as an Oral Presentation to global scholars, showcasing the results of its Phase II clinical study (REBUILDING-1) for the treatment of overweight or obesity in Chinese adults.

Data showed that the RAY1225 18mg group achieved an average weight reduction of 21.18% over the 24-week treatment period, with 100% of participants losing more than 15% of their body weight. These impressive results not only validate the powerful weight-loss potential of RAY1225 as a GLP-1/GIP biweekly formulation, but also mark another major breakthrough for Chinese innovative pharmaceutical companies in the global metabolic disease treatment arena.

Shining at ADA: Chinese Innovative Drug Takes Center Stage on the Global Academic Platform

This oral presentation was delivered by Professor Gao Leili from Peking University People's Hospital, with Professor Ji Linong from Peking University People's Hospital and Professor Yan Li from Sun Yat-sen Memorial Hospital of Sun Yat-sen University serving as co-Leading PIs. The ADA Annual Meeting is the world's largest and most academically prestigious scientific conference in the field of diabetes and metabolism. Each year, only a very small number of submissions are selected for oral presentations from thousands of entries. REBUILDING-1's selection for a live oral report represents high recognition from the international academic community for its study design, data quality, and clinical significance. This is not only a strong testament to Raynovent's international R&D capabilities, but also signals that Chinese-origin innovative drugs for metabolic diseases are rapidly advancing to the center of the global stage.

Impressive Data: Up to 21.2% Weight Loss at 24 Weeks

The REBUILDING-1 study (NCT06254261) is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial conducted in China, enrolling 243 participants who received subcutaneous injections once every two weeks (Q2W) for 24 weeks. Participants had a mean baseline weight of 92.34 kg, BMI of 32.72 kg/m², and waist circumference of 104.53 cm, with 92.18% having at least one weight-related comorbidity. The study population demonstrates full clinical representativeness and real-world significance.

REBUILDING-1 Study Design

Study results showed that after 24 weeks of treatment, all RAY1225 dose groups demonstrated significant and dose-dependent weight reduction effects, with the 9 mg group showing a 14.75% decrease from baseline and the 18 mg group showing a 21.18% decrease.

RAY1225 Injection: 24-Week Body Weight Change

Weight Loss Response Rate: 100% of 18mg Group Achieved ≥15% Target

At 24 weeks, the proportion of RAY1225 participants achieving weight reductions of ≥5%, ≥10%, and ≥15% from baseline was significantly higher than the placebo group in all dose groups. The 9 mg group achieved response rates of 95%, 88%, and 42% respectively, while the 18 mg group reached 100% across all three thresholds.

RAY1225 Injection: 24-Week Weight Loss Response Rate

Comprehensive Metabolic Benefits and Favorable Safety Profile

The therapeutic benefits of RAY1225 extend far beyond weight loss. At the metabolic level, both systolic and diastolic blood pressure were significantly reduced, with comprehensive improvements in total cholesterol (TC) and triglycerides (TG), as well as positive changes in ALT and UACR. Liver benefits were particularly notable: the maximum absolute reduction in liver fat reached 8.24%, with a maximum relative reduction of 72.28%, and 60.5%-100.0% of participants achieved ≥30% liver fat reduction, which holds significant strategic importance for the subsequent development of MASH indications. In terms of safety, most adverse events were mild to moderate gastrointestinal events, with no drug-related serious adverse events (SAE) and no new safety signals identified. The anti-drug antibody (ADA) positivity rate was 16.7%, with no neutralizing antibodies detected and no clinical impact on efficacy or safety. The overall safety profile was consistent with and comparable to similar drugs.

 RAY1225 Injection: 24-Week Liver Fat Content Change

Safety and Tolerability: Well-Characterized Profile, No New Safety Signals

In terms of safety, REBUILDING-1 study data further confirmed the favorable safety and tolerability profile of RAY1225. No new safety signals were identified during the study. Most adverse events (AEs) were mild to moderate gastrointestinal events, consistent with the safety profile of similar GLP-1 receptor agonists, with low incidence of nausea/vomiting, no drug-related serious adverse events (SAE), low incidence of injection site reactions, and very few hypoglycemic events.

Immunogenicity analysis showed that the treatment-emergent anti-drug antibody (ADA) positivity rate in the RAY1225 group was 16.7% (30/180), with no dose relationship, while the placebo group ADA positivity rate was 3.2% (2/63). Following administration, no GLP-1 or GIP neutralizing antibodies were detected, and ADA had no clinical impact on efficacy or safety. This safety profile lays a solid foundation for the smooth advancement of subsequent Phase III clinical studies and future commercial application of RAY1225.

Biweekly Formulation: Pioneering an Adherence Revolution

RAY1225 is designed using proprietary stapled peptide (stapled peptide) technology and is the world's first full-biased GLP-1/GIP receptor agonist. Stapled peptide technology introduces chemical scaffolds into peptide molecules, significantly enhancing structural stability and enzymatic resistance, giving RAY1225 an ultra-long half-life of approximately 10 days, thereby supporting once-every-two-weeks dosing (Q2W). Compared to existing weekly formulations, the Q2W regimen reduces 26 injections per year. In the field of chronic weight management, which requires long-term or even lifelong administration, dosing frequency directly determines patient long-term adherence and treatment persistence. RAY1225's differentiated biweekly dosing positioning is expected to fundamentally reshape the GLP-1 drug administration landscape, providing a more patient-friendly treatment option for hundreds of millions of people with metabolic diseases worldwide.

Accelerated R&D and Global Strategic Layout

Raynovent is advancing RAY1225 global clinical development at full speed. The weight reduction Phase III study (REBUILDING-2) and glycemic control Phase III studies (SHINING-2, SHINING-3) have both completed enrollment, and clinical trial applications for MASH and OSA indications have been approved. RAY1225 is the world's first GLP-1/GIP biweekly formulation to enter Phase III clinical trials, securing a first-mover advantage in a differentiated track. On the commercialization front, the company has reached a licensing cooperation agreement with Qilu Pharmaceutical worth up to RMB 1 billion, injecting strong momentum for subsequent global market expansion and in-depth penetration of the Chinese market. In the future, RAY1225 is expected to bring new treatment options to hundreds of millions of overweight, obese, and metabolic disease patients in China and worldwide. With solid clinical evidence and a global innovation vision, Raynovent is taking firm and powerful steps in the metabolic disease treatment field.

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REBUILDING-1 study data sourced from the 2026 ADA Oral Presentation and study abstract