Kailera Therapeutics Presents New Clinical Data at EASD 2026 Annual Meeting

The KAI-4729 12 mg group achieved mean weight loss of up to 16.0% from baseline at Week 12.

Rhea-AI Summary

Kailera Therapeutics (Nasdaq: KLRA) presented Phase 1 ribupatide injection data at EASD 2026 showing similar drug exposure across three injection sites. In 51 adults with obesity or overweight, upper-arm and thigh injections produced exposure similar to abdominal injections. Most treatment-emergent adverse events were mild and gastrointestinal; no new safety signals were identified.

Partner Hengrui Pharma also presented Phase 1 data for HRS-4729 (KAI-4729). At Week 12, the multiple-dose 12 mg group (N=10) achieved mean weight loss of up to 16.0% from baseline and a 67.3% mean reduction in liver fat content. Most adverse events were mild to moderate and gastrointestinal-related. Kailera plans a KAI-4729 Phase 1 trial outside China in 2026, with data expected in 2027. Ribupatide injection is in global Phase 3 trials; Kailera plans global Phase 3 trials of oral ribupatide in the first half of 2027.

8 points · 0 major

PositiveiHow this balance works

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.KAI-4729 Phase 1 trial outside China is planned for 2026, with data expected in 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Global Phase 3 oral ribupatide trials are planned by Kailera for the first half of 2027.
• Minor pointKAI-4729 12 mg (N=10) achieved mean weight loss of up to 16.0% from baseline at Week 12.
• Minor pointKAI-4729 12 mg (N=10) achieved a 67.3% mean reduction in liver fat content at Week 12.
• Minor pointRibupatide 4 mg active control (N=10) demonstrated 16.7% mean body-weight reduction at Week 12.

3 minor points

• Minor pointRibupatide 4 mg active control (N=10) demonstrated 38.4% mean liver-fat reduction at Week 12.
• Minor pointUpper-arm and thigh ribupatide injections produced drug exposure similar to abdominal injections in the Phase 1 trial.
• Minor pointRibupatide injection-site trial identified no new safety signals across injection sites.

Negative

• Minor pointRibupatide injection-site trial adverse events were mostly mild and gastrointestinal in nature.
• Minor pointHRS-4729 and ribupatide Phase 1 adverse events were mostly mild to moderate and gastrointestinal-related.

News Explained

At Week 12 in the Phase 1 multiple-dose study, the 12-mg HRS-4729 group (N=10) had mean weight loss of 16.0% and liver-fat reduction of 67.3%, versus 16.7% and 38.4%, respectively, for the 4-mg ribupatide group (N=10).

Key Figures

HRS-4729 mean weight loss: 16.0% HRS-4729 liver fat reduction: 67.3% Ribupatide mean body-weight reduction: 16.7% +1 more

HRS-4729 mean weight loss

16.0%

12 mg multiple-dose group, Week 12; N=10

HRS-4729 liver fat reduction

67.3%

12 mg multiple-dose group, Week 12; N=10

Ribupatide mean body-weight reduction

16.7%

4 mg active-control group; N=10

Ribupatide liver fat reduction

38.4%

4 mg active-control group; N=10

Previous Clinical trial Reports

2 past events · Latest: Sep 30

Same Type 2 events

1. Sep 30

   Phase 3 enrollment

   24h Move

   +3.9%

   Kailera completed enrollment in three global Phase 3 ribupatide trials.

2. Jun 05

   Ribupatide clinical data

   24h Move

   +1.7%

   Phase 1 injection data reported similar exposure and tolerability across participant groups.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

bioavailability, pharmacokinetics, pharmacodynamics, placebo-controlled, +1 more

5 terms

bioavailability medical

"effect of injection site on the relative bioavailability and safety"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

pharmacokinetics medical

"Safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"Safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase 1 study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

treatment-emergent adverse events medical

"Most treatment-emergent adverse events (TEAEs) were mild and gastrointestinal"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

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- 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/m² in 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:

• Efficacy and safety of ribupatide (HRS9531) in Chinese participants with obesity and polyendocrine metabolic ovarian syndrome (PMOS): a multicenter, randomized, double-blind, Phase 2 trial
• Oral small molecule GLP-1RA HRS-7535 as monotherapy in Chinese adults with early type 2 diabetes: the OUTSTAND-1 Phase 3 trial
• Oral HRS-7535 versus dapagliflozin in Chinese adults with type 2 diabetes inadequately controlled with metformin: the OUTSTAND-2 Phase 3 trial
  

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:

1. Marianne Camargo, MD. (2026, October 1). Effect of injection site on the relative bioavailability and safety of ribupatide, a novel dual GLP-1/GIP receptor agonist: Phase 1, randomized, single-dose crossover study result. Annual Meeting of the European Association for the Study of Diabetes (EASD), October 2026.
2. Wen Q, He K, Li C, et al. 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. Late-Breaking Abstract LBA 41. EASD 62nd Annual Meeting, Milan, 2026.

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Kailera's Phase 1 ribupatide injection-site trial show?

Ribupatide injections into the upper arm or thigh produced drug exposure similar to abdominal injections, supporting alternative injection locations. The trial enrolled 51 adults with obesity or overweight. Treatment was generally well tolerated irrespective of injection site, with no new safety signals identified.

What weight-loss results did Kailera's KAI-4729 show at EASD 2026?

At Week 12, participants receiving multiple doses of 12 mg HRS-4729 (KAI-4729) (N=10) achieved mean weight loss of up to 16.0% from baseline. That group also achieved a 67.3% mean reduction in liver fat content. The ribupatide 4 mg active-control group (N=10) demonstrated 16.7% mean body-weight reduction and 38.4% mean liver-fat reduction.

How was Kailera's ribupatide injection-site trial designed?

The Phase 1 trial used a randomized, single-dose crossover design, meaning participants received treatment at different injection sites in successive periods. It comprised three treatment periods using the abdomen, upper arm and thigh in randomized sequences, with n=17 per sequence. Participants received a single 2 mg dose on Day 1 of each 29-day period.

What other clinical programs did Hengrui present alongside Kailera's EASD 2026 data?

Hengrui's other presentations covered a Phase 2 ribupatide trial and two Phase 3 HRS-7535 trials. The ribupatide trial involved Chinese participants with obesity and polyendocrine metabolic ovarian syndrome. OUTSTAND-1 evaluated HRS-7535 alone in Chinese adults with early type 2 diabetes; OUTSTAND-2 compared it with dapagliflozin in Chinese adults whose diabetes was inadequately controlled with metformin.