EASD 2026 Oral Presentation: Raynovent's RAY1225 SHINING-1 Phase II Study Demonstrates Up to 2.76% HbA1c Reduction and 100% Target Achievement at 15mg Dose

MILAN — Raynovent's experimental diabetes drug RAY1225 delivered a striking performance at one of the world's most prestigious medical conferences, with Phase II trial data showing the biweekly injection slashed blood-sugar levels by as much as 2.76 percentage points and hit a perfect 100% target-achievement rate at the highest dose.

The results, presented as an oral report on Sept. 29 at the 62nd European Association for the Study of Diabetes annual meeting, mark the second time in four months that the Chinese-developed drug has taken center stage at a major international scientific gathering. In June, RAY1225's weight-loss data was featured as an oral presentation at the American Diabetes Association's annual conference — a rare double appearance that signals growing global recognition for China's homegrown metabolic-disease innovation.

"The SHINING-1 study was selected for oral presentation, which reflects the international academic community's high recognition of the study design, data quality and clinical significance," said Prof. Gao Leili of Peking University People's Hospital, who delivered the presentation. The study was led by Prof. Ji Linong, also of Peking University People's Hospital.

Among participants receiving the 15-milligram dose of RAY1225 for 24 weeks, the average HbA1c dropped 2.76 percentage points to 5.34% — a level approaching the normal range — and 100% of patients achieved the HbA1c target of below 7%.

The SHINING-1 trial, registered as NCT06254274, was a multicenter, randomized, double-blind, placebo-controlled Phase II study conducted across China. It enrolled 243 participants who received subcutaneous injections every two weeks for 24 weeks. At baseline, participants had an average weight of 80.02 kilograms, a body-mass index of 29.07 kg/m², an HbA1c of 8.05%, a fasting glucose of 9.32 mmol/L, and a mean diabetes duration of 4.53 years. About 35.5% were treatment-naïve patients, and 40.7% had at least one diabetes-related complication.

Across all dose groups — ranging from 3 mg to 15 mg — the drug produced statistically significant, dose-dependent reductions in HbA1c. Reductions ranged from 1.66 to 2.76 percentage points, all significantly outperforming the placebo group's decline of just 0.25 percentage points, with p-values below 0.001. In the 6 mg to 15 mg groups, HbA1c fell to between 5.34% and 6.07%, approaching levels considered within the normal range.

The target-achievement rates were equally impressive. The share of participants reaching HbA1c below 7% climbed from 80.0% in the 3 mg group to 100% in the 15 mg group. For the stricter HbA1c threshold of 6.5% or lower, rates rose from 60.0% to 100%. Under the most rigorous standard of HbA1c below 5.7%, 71.4% of patients in the 15 mg group still met the mark. Perhaps most notably, 100% of patients in the 15 mg group achieved a composite endpoint of HbA1c below 7% combined with weight loss of 5% or more — suggesting the drug delivers simultaneous blood-sugar and weight benefits.

Weight loss, a critical secondary benefit for metabolic-disease patients, was substantial. In the 24-week treatment period, body weight declined in a dose-dependent fashion across all groups — from a 2.42 kg reduction in the 3 mg arm to a 12.87 kg drop in the 15 mg arm, compared with just 1.39 kg in the placebo group. In the 15 mg group, 100% of patients achieved at least 5% weight loss, 85.7% lost 10% or more, and 42.9% shed 15% or more. Waist circumference in the 15 mg group decreased by 11.58 centimeters.

Beyond glucose control and weight reduction, RAY1225 showed broad improvements across cardiovascular, renal and metabolic risk factors. In the 15 mg group, systolic blood pressure fell by 22.21 mmHg and diastolic blood pressure dropped by 11.55 mmHg. Total cholesterol, triglycerides and free fatty acids all trended downward, as did non-HDL cholesterol.

Liver and kidney function markers also improved. Alanine aminotransferase, or ALT, decreased by as much as 16.03 U/L, while aspartate aminotransferase, or AST, fell by up to 6.76 U/L. The estimated glomerular filtration rate and the urine albumin-to-creatinine ratio showed positive trends across all dose groups, with more than 50% of patients who had abnormal baseline UACR values returning to normal within 24 weeks.

On safety, the trial confirmed RAY1225's favorable tolerability profile. Most adverse events were mild to moderate gastrointestinal issues consistent with other GLP-1 receptor agonists: diarrhea occurred in 28.2% of patients, bloating in 11.8%, nausea in 10.6% and vomiting in 8.2%, with most events occurring during the dose-escalation phase. Serious adverse events were rare, and the rate of treatment discontinuation due to adverse events was low.

Hypoglycemia events were infrequent and mostly Grade 1. No cases of hypersensitivity, injection-site reactions, pancreatitis, acute cholecystitis or thyroid malignancy were reported. Immunogenicity analysis showed that treatment-emergent anti-drug antibody positivity was 12.4% (21 of 169 patients) in the RAY1225 group versus 4.8% (3 of 63) in the placebo group, with no dose relationship. No neutralizing antibodies against GLP-1 or GIP were detected after dosing, and the anti-drug antibodies had no clinically meaningful impact on efficacy or safety.

What sets RAY1225 apart in the crowded GLP-1 landscape is its dosing schedule. Designed using patented stapled-peptide technology — in which a chemical scaffold is introduced into the peptide molecule to enhance structural stability and resist enzymatic degradation — the drug achieves an approximately 10-day half-life, enabling once-every-two-weeks subcutaneous injections. Compared with existing weekly formulations, the biweekly regimen eliminates 26 injections per year, a meaningful advantage for patients managing chronic metabolic diseases that require long-term or even lifelong therapy.

Raynovent is now accelerating RAY1225's global clinical development. Phase III studies for diabetes — SHINING-2 and SHINING-3 — and a Phase III weight-loss trial, REBUILDING-2, are all underway. Clinical trial applications for metabolic dysfunction-associated steatohepatitis, or MASH, and obstructive sleep apnea have already been approved. RAY1225 is the first GLP-1/GIP biweekly formulation to enter Phase III clinical trials, giving it a first-mover advantage in a differentiated competitive track.

On the commercialization front, the company has struck a licensing deal with Qilu Pharmaceutical worth up to 1 billion yuan (approximately $138 million) for marketing rights in China, providing fuel for deeper domestic market penetration and future global expansion.

From the ADA stage in June to the EASD podium in Milan, RAY1225's back-to-back international appearances are building a compelling case: China's pipeline of homegrown, dual-target metabolic therapies is no longer a distant promise — it is delivering data that can stand shoulder to shoulder with the best in the world.

Data source: SHINING-1 study data from the 2026 EASD oral presentation and study abstract.