Kailera Therapeutics Presents New Clinical Data at EASD 2026 Annual Meeting

- New Phase 1 data highlight flexibility of injection site for ribupatide injection

- Four additional oral presentations from Hengrui Pharma add to the clinical evidence behind Kailera's pipeline

WALTHAM, Mass., Oct. 01, 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 Phase 1 data for ribupatide injection, a GLP-1/GIP receptor dual agonist currently advancing through global Phase 3 clinical trials, presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). In addition, partner Hengrui Pharma delivered four oral presentations highlighting clinical data from programs now in global development by Kailera, including ribupatide injection, oral small molecule GLP-1 receptor agonist safiglipron, also known as KAI-7535 (HRS-7535), and injectable GLP-1/GIP/glucagon receptor tri-agonist KAI-4729 (HRS-4729).

EASD 2026 Presentations

Ribupatide Phase 1 Injection Site Clinical Trial

Kailera's Phase 1 single-dose, crossover trial investigated the effect of injection site on the relative bioavailability and safety of ribupatide injection administered subcutaneously in adults living with obesity or overweight. The trial enrolled 51 participants and consisted of three treatment periods, each with a different injection site (abdomen, upper arm, thigh) administered according to a randomized sequence (n=17 per sequence). Participants received a single 2 mg dose of ribupatide injection on Day 1 of each 29-day period. Plasma drug exposure following subcutaneous ribupatide injection to the upper arm or thigh was similar to that observed following abdominal injection, supporting these sites as alternative injection locations. Ribupatide injection was generally well tolerated irrespective of injection site, with no new safety signals identified; most treatment-emergent adverse events (TEAEs) were mild and gastrointestinal in nature.

Additional Presentations at EASD 2026

Among four additional presentations on GLP-1 therapeutics from partner Hengrui Pharma, new Phase 1 findings for HRS-4729 (KAI-4729) provided an early look at the clinical profile of the investigational GLP-1/GIP/glucagon receptor tri-agonist in obesity.

Safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729, a novel GLP-1/GIP/glucagon triple-receptor agonist: a randomized, double-blind, placebo-controlled Phase 1 study

The randomized, double-blind, placebo-controlled first-in-human trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729 (KAI-4729) injection in adult participants with a baseline BMI ranging from 19 kg/m² to 35 kg/m²in the SAD portion and from 28 kg/m² to 40 kg/m² in the MAD portion. Participants received once-weekly doses of 1 mg, 4 mg, 8 mg or 12 mg HRS-4729, 4 mg ribupatide (active control) or placebo for 12 weeks. In the MAD portion of the trial at Week 12, participants receiving multiple doses of 12 mg of HRS-4729 (N=10) achieved a mean weight loss of up to 16.0% from baseline and 67.3% mean reduction in liver fat content. Ribupatide (4 mg) (N=10) demonstrated a mean reduction in body weight of 16.7% and 38.4% mean reduction in liver fat content. HRS-4729 and ribupatide injection demonstrated favorable safety and tolerability data consistent with GLP-1-based treatments. Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related.

Kailera plans to initiate a Phase 1 clinical trial of KAI-4729 outside of China in 2026, with data expected in 2027.

Other presentations by Hengrui Pharma include:

All presentations will be accessible on the Scientific Publications section of the Kailera website following the congress. Additional information can be found on the EASD website.

References:

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 Phase 3 global trials 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 safiglipron (also known as 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, and the availability of publications. 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

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