Kailera says oral ribupatide IND is active, with Phase 3 obesity trials planned for 2027

Kailera Therapeutics says the US investigational new drug application for an oral form of ribupatide is active, and the company plans to start global Phase 3 trials of the drug in obesity in the first half of 2027 ^[2]. The update was released with the company's second-quarter 2026 results ^[2].

The company also said its US Phase 2b trial of a high-dose injectable form of ribupatide in obesity is fully enrolled, with data expected in mid-2027 ^[2]. Its global Phase 3 program, called KaiNETIC, is on track for more than 4,700 participants, with data expected in 2028 ^[2]. No results from the ribupatide program were disclosed, and the company has not reported how much weight participants lost or what side effects they had.

A separate drug database entry for a Kailera-partnered molecule listed as HRS-7535 and KAI-7535 describes an oral, small-molecule GLP-1 receptor agonist ^[1]. Whether that molecule is the same as ribupatide has not been reported. The entry includes data from earlier trials. In a Phase 1 study in healthy volunteers, the mean reduction in body weight from baseline on day 29 was 4.38 kilograms, or 6.63%, for participants who received HRS-7535, compared with 0.8 kilograms, or 1.18%, for those who received a placebo. Nausea and vomiting were the most frequently reported side effects, and the safety profile was described as consistent with other GLP-1 receptor agonists ^[1].

In a 16-week Phase 2 trial of 194 adults with type 2 diabetes that was not adequately controlled with metformin, average HbA1c fell by 1.19% to 1.82% from baseline depending on dose, compared with 0.25% with placebo. At the 90 mg dose, body weight fell by 2.63%, compared with 1.30% with placebo ^[1].

Regulatory progress for that molecule is furthest along in China. The country's drug regulator has accepted a marketing application for HRS-7535 tablets for long-term weight management in adults with a body mass index of 28 or higher, or 24 or higher with at least one weight-related condition ^[1]. The filing followed topline results from the Phase 3 HARBOR-1 trial, in which 556 adults at 50 centers in China received once-daily HRS-7535 at 120 mg or 180 mg, or placebo; all dose groups met the primary and key secondary endpoints at 44 weeks ^[1]. Two more Phase 3 trials of the molecule are listed with 2026 start dates, one in chronic kidney disease and one in hypertension in people with overweight or obesity, along with a Kailera-sponsored Phase 2 trial of oral KAI-7535 in adults with obesity or overweight that began in April 2026 ^[1].

Why it matters for patients

Nothing in this update changes the medicines available in the US today, including Ozempic and Wegovy (semaglutide), Rybelsus (oral semaglutide), or Mounjaro and Zepbound (tirzepatide). Ribupatide is not approved in the US, and no US regulatory filing for it has been reported ^[2].

The reported timeline matters. If the Phase 3 obesity trials do begin in the first half of 2027 and produce data in 2028 ^[2], an approval decision would come after that, not before. An oral GLP-1 would be appealing to people who want to avoid injections, but there is no data yet showing how ribupatide compares with approved medicines.

Side effects are a consideration across this drug class. In earlier testing of the Kailera-partnered molecule, nausea and vomiting were the most common side effects reported ^[1]. Kailera has not disclosed pricing or insurance plans for ribupatide.

What happens next

• First half of 2027: global Phase 3 obesity trials of oral ribupatide are planned to begin ^[2].
• Mid-2027: data are expected from the US Phase 2b trial of high-dose injectable ribupatide, which is fully enrolled ^[2].
• 2028: data are expected from the KaiNETIC Phase 3 program, which is on track for more than 4,700 participants ^[2].

Kailera has not disclosed the design of the Phase 3 trials or when it would seek FDA approval.