ribupatide oral (HRS9531 tablet) / Jiangsu Hengrui Pharma, Kailera Therapeutics - LARVOL DELTA

Anticipated Key Milestones (GlobeNewswire) - "(i) Ribupatide injection: U.S. Phase 2b high dose obesity data anticipated in mid-2027; global Phase 3 obesity data anticipated in 2028; (ii) Ribupatide oral: Global Phase 3 obesity trial initiations anticipated in the first half of 2027."

New P3 trial • P2 data • P3 data • Obesity

A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects (clinicaltrials.gov) - P3 | N=675 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | N=425 ➔ 675 | Trial completion date: Aug 2027 ➔ Nov 2027 | Trial primary completion date: Jul 2027 ➔ Oct 2027

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Obesity

A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | N=144 ➔ 100 | Trial completion date: Nov 2024 ➔ Sep 2026 | Trial primary completion date: Nov 2024 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects (clinicaltrials.gov) - P3 | N=425 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P3 trial • Obesity

Efficacy and Safety of Oral Ribupatide (HRS9531) in Adults with Obesity: A Phase 2 Trial (ADA 2026) - "Oral ribupatide demonstrated significant weight loss in adults with obesity at W26 with no observed plateau and a favorable safety profile."

Clinical • Late-breaking abstract • P2 data • Diabetes • Metabolic Disorders • Obesity

Phase 2 Clinical Trial of Ribupatide Oral in Adults Living with Obesity (GlobeNewswire) - "Hengrui Pharma and Kailera Therapeutics present ribupatide clinical data at ADA 2026....Based on the efficacy estimand^I, participants taking ribupatide oral achieved a mean weight loss of 6.9% (10 mg), 12.1% (25 mg), and 12.1% (50 mg) from baseline, with no observed plateau in weight loss, compared to 2.3% with placebo. Based on the treatment policy estimand^II at Week 26, participants taking ribupatide oral achieved a mean weight loss of 6.7% (10 mg), 11.9% (25 mg), and 11.4% (50 mg) from baseline, with no observed plateau in weight loss, compared to 2.1% with placebo. At week 26, ribupatide oral outperformed placebo in the proportion of participants achieving ≥5%, ≥10% and ≥15% body weight reduction."

P2 data • Obesity

Ribupatide oral (KAI-9531-T), GLP-1/GIP receptor dual agonist (GlobeNewswire) - "The full data will be presented in a poster presentation at ADA 2026; Subject to discussions with the FDA and other regulatory agencies, Kailera plans to initiate Phase 3 global trials as early as the first half of 2027."

New P3 trial • P2 data • Obesity

A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hengrui Pharma and Kailera Therapeutics Announce Clinical Data Presentations at the American Diabetes Association 86th Scientific Sessions (GlobeNewswire) - "The presentations will feature clinical results for oral and injectable ribupatide, a GLP-1/GIP receptor dual agonist, highlighting the potential of the ribupatide franchise to deliver potentially differentiated options for people living with obesity and overweight. Hengrui will present data from their Phase 2 clinical trial of oral ribupatide in adults living with obesity, and Kailera will present data from their Phase 1 bridging study of ribupatide injection, which supported the initiation of Kailera’s ongoing global Phase 3 KaiNETIC clinical program."

P1 data • P2 data • Obesity

Kailera outlines plans for $528.5M IPO to support quartet of Chinese obesity assets (FierceBiotech) - "The filing also outlines how the proceeds will be used to develop Kailera’s obesity assets, including injectable ribupatide, oral ribupatide and KAI-7535...With IPO funding and existing cash, Kailera plans to allocate $625 million to support injectable ribupatide, funding three ongoing global phase 3 trials through the second quarter of 2028...The funds will be used for planned phase 3 trials beginning in the second quarter of 2028...KAI-7535, a once-daily injectable small-molecule GLP-1, will receive a $50 million boost following the IPO...Kailera’s fourth obesity asset, KAI-4729—a once-weekly injectable GLP-1—will also benefit from the funding and is currently in a phase 1 trial in China."

Financing • New P3 trial • Trial status • Obesity

Efficacy and Safety of HRS9531 Tablet in Obese Subjects (clinicaltrials.gov) - P2 | N=166 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Obesity

Kailera Plans IPO for Obesity Drug That Could Top Lilly’s Zepbound (MedCityNews) - "As is typical of such initial filings, there are no financial details yet about how many shares the company plans to offer and how much it aims to raise. Kailera has applied for a Nasdaq listing under the stock symbol 'KLRA'. Lead Kailera drug candidate ribupatide, formerly known as KAI-9531, is an injectable peptide engineered to activate GLP-1 and GIP receptors in the gastrointestinal tract....An oral version of the Kailera drug posted positive results from a Phase 2 test in China; a global mid-stage study is expected to begin later this year."

Commercial • New P2 trial • Obesity

Kailera Therapeutics and Hengrui Pharma Report Positive Topline Data from Phase 2 Obesity Trial of Oral Ribupatide (Kailera Press Release) - "Hengrui to rapidly advance oral ribupatide to Phase 3 trial in China; Kailera plans to initiate a global Phase 2 clinical trial in 2026...Participants receiving oral ribupatide demonstrated a mean weight reduction from baseline of up to 12.1% at 26 weeks based on the efficacy estimandI with no observed plateau in weight loss, and vomiting reported in no more than 11.4% of participants taking oral ribupatide...Additionally, at the 25 mg dose, 59.1% of participants achieved at least 10% weight loss, and 38.6% of participants achieved at least 15% weight loss at Week 26. At the 50 mg dose, 52.5% of participants achieved at least 10% weight loss....Hengrui intends to share the full oral ribupatide Phase 2 clinical trial data at an upcoming scientific conference."

New P2 trial • New P3 trial • P2 data • Obesity

Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Kailera Therapeutics Announces $600 Million Series B Financing to Further Advance Pipeline of Next-Generation Therapies for the Treatment of Obesity (GlobeNewswire) - "The financing will be fully funded at closing and will support the advancement of Kailera’s leading obesity portfolio, including a global Phase 3 clinical program of Kailera’s lead candidate KAI-9531, an injectable dual GLP-1/GIP receptor agonist with potentially best-in-category weight loss...The Phase 3 program will include two trials in adults living with obesity or overweight with comorbidities, with and without type 2 diabetes, and an additional trial in adults living with a BMI of 35 or higher...'We look forward to starting our global Phase 3 trials of KAI-9531 by the end of this year'....The financing will also advance KAI-7535..."

Financing • New P3 trial • Obesity • Type 2 Diabetes Mellitus

Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects (clinicaltrials.gov) - P1 | N=168 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 Tablet, an Oral Dual GLP-1/GIP Receptor Agonist, in Healthy Participants—A Phase 1 Study (ADA 2025) - "HRS9531 tablet showed a favorable safety and tolerability profile, with noticeable reductions in body weight and glucose levels. Results support further clinical development of HRS9531 tablet for metabolic disorders."

Clinical • P1 data • PK/PD data • Hypertriglyceridemia • Hypoglycemia • Metabolic Disorders

Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics Announce Clinical Data Presentations at the American Diabetes Association 85th Scientific Sessions (The Manila Times) - "Jiangsu Hengrui Pharmaceuticals Co., Ltd...and Kailera Therapeutics, Inc...announced the presentation of six abstracts at the 85th Scientific Sessions of the American Diabetes Association (ADA), taking place June 20-23, 2025, in Chicago, IL. The presentations will highlight the breadth of the companies' metabolic disease portfolio, including data from several clinical-stage injectable and oral therapies. Data presented will cover results from clinical trials sponsored and conducted by Hengrui for an injectable GLP-1/GIP receptor dual agonist HRS9531 (in development as KAI-9531 outside of Greater China), an oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535), and an oral formulation of HRS9531 (KAI-9531)."

Clinical data • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of HRS9531 Tablet in Obese Subjects (clinicaltrials.gov) - P2 | N=166 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Obesity

A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and Safety of HRS9531 Tablet in Obese Subjects (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Obesity

Efficacy and Safety of HRS9531 Tablet in Obese Subjects (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P2 trial • Obesity

Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus