TRIAL SUCCESS

Hengrui's oral HRS-7535 matches dapagliflozin on HbA1c in Phase 3 diabetes trial

OUTSTAND-2 hit its non-inferiority bar against dapagliflozin, and the 90 mg dose topped it on HbA1c, positioning an oral GLP-1 pill against China's SGLT2 standard of care.

By AppliedXLJuly 7, 2026Trial NCT06589765

Executive Summary

An oral GLP-1 pill from Hengrui Pharma matched and, at its top dose, beat a leading SGLT2 inhibitor on blood sugar control in a completed Phase 3 trial in China.
The trial was designed to prove HRS-7535 belongs alongside an established oral standard of care, not just against placebo, and the topline data clear that higher bar.
Hengrui now plans to file for approval in China, making this readout the clinical basis for that filing rather than a preliminary signal.
The headline numbers are topline only, with the full dataset, durability, and safety detail still to be presented at upcoming scientific meetings.

The readout

OUTSTAND-2, a Phase 3 trial registered as NCT06589765, tested HRS-7535 (also known as KAI-7535) against dapagliflozin 10 mg in 810 adults with type 2 diabetes inadequately controlled on metformin. The registered primary endpoint was change from baseline in HbA1c at 32 weeks of treatment. Hengrui Pharma reported on July 7, 2026 that the trial met that endpoint: HbA1c fell by 1.58% with the 30 mg dose, 1.50% with 60 mg, and 1.68% with 90 mg, against a 1.28% reduction for dapagliflozin, with the 90 mg group showing a statistically significant reduction versus the comparator. NCT06589765+1

Probability of Success

Endpoint Met97%

Completes99%

Clinical Significance36%

Regulatory90%

What the trial tested

The design matters because dapagliflozin is not a placebo stand-in; it is an active, approved oral glucose-lowering drug. Meeting non-inferiority against an SGLT2 inhibitor, then beating it at the top dose, is a different and higher bar than the placebo comparisons more common in early Phase 3 GLP-1 programs. The trial enrolled its full target of 810 participants, completed on May 29, 2026, and moved to Completed status by June 30, 2026, with liver safety findings described as consistent with prior data and no liver safety signals observed across HRS-7535's two Phase 3 trials in China. Kailera

Competitive and regulatory frame

SGLT2 inhibition in type 2 diabetes is a mechanism with an established track record: 123 completed and 16 terminated Phase 3 trials for the target-indication pair put the historical failure rate at 12%, and 28 active trials are still testing SGLT2 inhibitors in this indication. HRS-7535 is the only Phase 3 asset registered against the GLP-1 receptor in this specific target-indication comparison, giving it a direct read against an SGLT2 standard rather than against other oral GLP-1 competitors, none of which have yet reached Phase 3 head-to-head testing here. Hengrui has said it plans to submit NDAs for HRS-7535 in both type 2 diabetes and obesity in China, and intends to present full HARBOR-1 and OUTSTAND-2 data at upcoming scientific conferences. Kailera

The obesity readthrough

The same press release disclosed topline results from a second Phase 3 trial, HARBOR-1, testing HRS-7535 in obesity and overweight adults in China, where the drug produced weight loss of up to 10.9% at Week 44 and up to 11.1% at Week 50. Kailera Therapeutics licensed HRS-7535 outside Greater China in 2024 and is running a global Phase 2 trial of the same molecule, as KAI-7535, in obesity, with data expected in 2027. The type 2 diabetes and obesity results together frame HRS-7535 as a single oral small molecule being pushed across both indications on the strength of over 2,000 patients dosed in China to date. Kailera

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.