Kailera Therapeutics and its partner Jiangsu Hengrui Pharmaceutical reported that the oral GLP-1 receptor agonist HRS-7535 met the primary endpoints in two Phase 3 clinical trials conducted in China, one involving adults with obesity or overweight and the other involving adults with Type 2 diabetes.
Hengrui is developing HRS-7535, which Kailera refers to as KAI-7535, in Greater China, while Kailera holds rights to the drug outside the region. The Phase 3 results position Hengrui to seek approval for the drug in obesity and diabetes in China.
In the obesity study, HRS-7535 was associated with a mean weight loss of up to 10.9% at Week 44, compared with 2.5% for placebo. An ad hoc analysis showed mean weight loss reaching 11.1% at Week 50. These analyses excluded data collected after premature treatment discontinuations or the use of drugs with an obvious effect on weight. When those data were included, the mean weight loss at Week 44 was 9.8% among participants receiving the highest dose of HRS-7535.
Kailera Chief Executive Officer Ronald Renaud discussed expectations for oral obesity medicines at a Jefferies event last month, stating that “we are going to have weight loss in a very tight band, somewhere between 10% and 15%.” Renaud also said that safety and tolerability are where differentiation is likely to occur among products that deliver similar levels of weight loss.
The obesity trial also reported treatment-emergent adverse events. Nausea was the most common event, affecting 70% of patients receiving HRS-7535 compared with 16.2% of those receiving placebo. Vomiting occurred in up to 68.6% of participants on HRS-7535 and 4.5% of participants on placebo. Diarrhea was reported in 36.9% of patients receiving HRS-7535 and 15.3% of those receiving placebo.
Results from the diabetes study showed reductions in HbA1c, a measure of blood sugar levels, of up to 1.68% when excluding data collected after premature treatment discontinuations or the use of other glucose-lowering medications. Hengrui also reported that HRS-7535 was non-inferior to dapagliflozin across dose levels in reducing HbA1c. In the trial, HbA1c fell by 1.28% on dapagliflozin, an SGLT2 inhibitor sold by AstraZeneca as Farxiga.
According to Kailera, more than 2,000 participants have received HRS-7535 in clinical trials in China. The company also said that no liver safety signals were observed in either Phase 3 study.
The results add to the data generated for one of two oral weight-loss drugs being developed by Kailera. The company is also advancing an oral peptide that targets GLP-1 and GIP.
Kailera launched in October 2024 with $400 million in early-stage funding and four obesity drug candidates licensed from Hengrui. In April, the company raised $625 million in an initial public offering.
Outside Greater China, Kailera started a global Phase 2 trial of HRS-7535 in overweight or obese adults in April, with data expected next year. Earlier this year, the company reported that the oral version of its lead drug, ribupatide, helped patients lose up to 12.1% of body weight at 26 weeks in a mid-stage study conducted in China.
Kailera and Hengrui have announced encouraging Phase 3 clinical trial results for their investigational oral GLP-1 therapy designed to treat obesity and type 2 diabetes. The latest findings represent an important milestone for Kailera as the company advances the development of a convenient oral treatment option that could expand access to metabolic disease therapies and improve patient adherence.
Kailera Achieves Positive Phase 3 Milestone
The successful Phase 3 study demonstrates Kailera’s continued progress in developing innovative therapies for chronic metabolic conditions. The trial evaluated the oral GLP-1 candidate in patients with obesity and type 2 diabetes, measuring its effectiveness in improving glycemic control and supporting meaningful weight reduction.
Positive results strengthen Kailera’s regulatory pathway and support future submission plans in multiple markets.
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