- Ribupatide injection (KAI-9531) aims to address critical need for greater weight loss, especially for people living with a BMI of 35 kg/m² or higher

- Topline data now expected in mid-2028

WALTHAM, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (NASDAQ:KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today announced the completion of enrollment in the KaiNETIC global Phase 3 clinical program. The KaiNETIC program, which encompasses three trials – KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 – is evaluating ribupatide injection (also known as KAI-9531), an investigational once-weekly dual GLP-1/GIP receptor agonist peptide, for the treatment of people living with obesity or overweight.

Topline data from KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 are now expected in mid-2028.

"Obesity is a complex, chronic disease, and millions of people still struggle to find a treatment that meets their needs," said Scott Wasserman, M.D., Chief Medical Officer, Kailera. "Completing enrollment across all three KaiNETIC trials is an important milestone that brings us one step closer to delivering ribupatide injection to patients as a potential best-in-class medicine."

About the KaiNETIC Phase 3 Program

KaiNETIC is a global Phase 3 program consisting of three double-blind, randomized, placebo-controlled Phase 3 clinical trials designed to evaluate the efficacy and safety of ribupatide injection for the treatment of obesity or overweight. The trials evaluate ribupatide doses up to 10 mg administered by weekly subcutaneous injection over a period of 76 weeks, with dose titration for up to 24 weeks and a maintenance dose of at least 52 weeks. Participants were enrolled at more than 200 investigative sites across eleven countries in North America, Europe, the United Kingdom, Oceania, and South America.

KaiNETIC-1 enrolled approximately 2,500 adults with a BMI of 30 kg/m² or greater, or a BMI of 27 kg/m² or greater with a comorbidity, excluding type 2 diabetes. The primary endpoint is percentage change in body weight from baseline at Week 76.

KaiNETIC-2 enrolled approximately 1,200 adults with a BMI of 27 kg/m² or greater and type 2 diabetes. The co-primary endpoints of this trial are percentage change in body weight from baseline at Week 76 and change in hemoglobin A1c from baseline at Week 76.

KaiNETIC-3 enrolled approximately 1,200 adults with a BMI of 35 kg/m² or greater and without type 2 diabetes. The co-primary endpoints of this trial are percentage change in body weight from baseline compared to placebo at Week 76 and percentage change in body weight from baseline compared to semaglutide 2.4 mg at Week 76.

In KaiNETIC-1 and KaiNETIC-2, participants were randomized to one of five arms – ribupatide 4 mg, 6 mg, 8 mg or 10 mg, or placebo, and both trials will also evaluate ribupatide in a pre-defined subgroup of participants with a BMI of 35 kg/m² or greater. In KaiNETIC-3, participants were randomized to one of four arms – ribupatide 8 mg or 10 mg, placebo, or open-label semaglutide 2.4 mg.

About Ribupatide

Ribupatide is a GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent insulinotropic polypeptide) receptor dual agonist peptide being developed as a once-weekly subcutaneous injection and as a once-daily oral pill for the treatment of obesity and overweight. Once-weekly ribupatide injection has been studied in more than 3,000 clinical trial participants who have been dosed with treatment out to 52 weeks, including in multiple late-stage clinical trials conducted by Hengrui in China. Hengrui submitted an NDA to the National Medical Products Administration (NMPA) in China for long-term weight management in adults. In May 2024, Hengrui granted Kailera exclusive global rights outside Greater China to develop, manufacture and commercialize its portfolio of innovative GLP-1 therapeutics, including ribupatide injection and ribupatide oral. Kailera is currently evaluating ribupatide injection for the treatment of obesity in the KaiNETIC global Phase 3 clinical program. Based on compelling clinical data to date, Hengrui is advancing once-daily ribupatide oral to Phase 3 clinical trials in China, and Kailera plans to initiate planned global Phase 3 trials in obesity in the first half of 2027.

About Kailera Therapeutics

Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit www.kailera.com and follow us on LinkedIn and X.

Special Note Regarding Kailera Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the profile of product candidates, the potential of Kailera’s portfolio, the timing, design and outcome of research and development activities, including with respect to the timing of initiation and completion of clinical trials and the design and goals of clinical trials, market opportunities for product candidates, and the competitive landscape. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "suggest," "plan," "goal," "vision," "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development, regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption "Risk Factors" in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements.

Contact Information

Maura Gavaghan

Vice President, Investor Relations

maura.gavaghan@kailera.com

Anna Robinson

Vice President, Communications

anna.robinson@kailera.com