KAI-7535, an investigational oral GLP-1 pill from Kailera and Hengrui, showed 10.9% weight loss and up to 1.68% A1C cut in Chinese Phase 3 trials. Not FDA-approved.
KAI-7535, an investigational oral GLP-1 pill from Kailera and Hengrui, posted positive Phase 3 data in China: about 10.9% mean weight loss at 44 weeks in obesity and up to 1.68% A1C reduction in type 2 diabetes. It is not FDA-approved, and a global trial reads out in 2027.
Kailera Therapeutics and its partner Hengrui Pharma reported positive topline results on July 7, 2026, from two Chinese Phase 3 trials of KAI-7535 (known as HRS-7535 in China), a small-molecule oral GLP-1 receptor agonist studied for obesity and type 2 diabetes. The KAI-7535 oral GLP-1 pill is investigational and is not approved by the FDA or any other regulator.
The data land in a crowded race to build a convenient once-daily weight-loss pill as an alternative to FDA-approved injectable drugs like semaglutide and tirzepatide. Here is what the trials showed, what remains unproven, and why a U.S. readout is still more than a year away.
In the HARBOR-1 obesity trial, 556 adults in China (mean baseline weight 94.1 kg, mean BMI 34.0) received KAI-7535 or placebo. At week 44, the 180 mg dose produced a mean weight loss of 10.9% by one analysis, or 9.8% by a more conservative measure, versus 2.4% to 2.5% for placebo, meeting the primary endpoint. The 120 mg dose reached roughly 8% to 9.5%. A week 50 analysis showed up to 11.1% at the top dose, and about 46.6% of patients on 180 mg lost at least 10% of body weight.
In the OUTSTAND-2 diabetes trial, 810 adults with type 2 diabetes (mean baseline A1C 8.60%) took KAI-7535 or the FDA-approved SGLT2 inhibitor dapagliflozin. At week 32, the 90 mg dose lowered A1C by 1.68%, compared with 1.28% for dapagliflozin. Both trials were conducted in China and remain investigational. Hengrui said it plans to file for approval in China, but KAI-7535 is not FDA-approved and is not available in the United States.
An effective oral GLP-1 could reach patients who avoid needles, and pills are generally cheaper to manufacture and distribute than injections. KAI-7535 would compete with other oral candidates racing toward market, including Eli Lilly's orforglipron, which is also investigational, and an oral form of Novo Nordisk's semaglutide.
The weight-loss figures, near 11%, trail the results seen with high-dose injectable tirzepatide, so KAI-7535's place in treatment is not yet clear. Gastrointestinal side effects were also common: nausea affected roughly 70% of treated patients versus about 16% on placebo, and vomiting affected up to nearly 69%. Discontinuation due to adverse events was low, at 3.1% on the 180 mg dose, and investigators reported no liver safety signal. These are topline numbers from the sponsor; full peer-reviewed data have not yet been published.
The Chinese Phase 3 results do not translate into U.S. availability. Kailera licensed KAI-7535 outside Greater China in 2024 and began a global Phase 2 obesity trial in April 2026, enrolling about 320 participants across the United States and Australia at doses up to 360 mg, with data expected in 2027. A U.S. regulatory decision, if the program advances, would come later still.
Readers considering weight-loss or diabetes treatment should know that KAI-7535 cannot be prescribed today and that only FDA-approved options are available through licensed clinicians. Anyone weighing an approved injectable or oral GLP-1 should discuss the risks and benefits with a qualified provider rather than acting on early trial data.