HRS9531 injection / Jiangsu Hengrui Pharma, Kailera Therapeutics - LARVOL DELTA

A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices (clinicaltrials.gov) - P1 | N=51 | Completed | Sponsor: Kailera | Active, not recruiting ➔ Completed

Trial completion

HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction (clinicaltrials.gov) - P2 | N=203 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2025 ➔ Jan 2026

Enrollment closed • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Obesity

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Phase 3 Trial of HRS9531, a GLP-1/GIP Receptor Agonist, in Chinese Adults With Overweight or Obesity (OBESITY WEEK 2025) - "In this 48-week trial in Chinese adults with overweight or obesity, HRS9531 substantially reduced body weight and provided comprehensive metabolic improvements, with a well-tolerated safety profile."

Clinical • P3 data • Cardiovascular • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

NDA submitted in China by Hengrui; Kailera plans to start global Phase 3 trials by year-end evaluating multiple maintenance doses including 8 mg (GlobeNewswire)

China filing • New P3 trial • Obesity

Hengrui Pharma and Kailera Therapeutics Announce Additional Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531 (GlobeNewswire) - "Based on the hypothetical strategy estimand, participants taking HRS9531 achieved a mean weight loss of 11.2% (2 mg), 17.4% (4 mg) and 19.2% (6 mg), compared to placebo (1.4%). Based on the treatment policy estimand, participants taking HRS9531 achieved a mean weight loss of 10.7% (2 mg), 16.4% (4 mg) and 17.7% (6 mg), compared to placebo (1.4%). Based on the treatment policy estimand, 68.1% (2 mg), 88.0% (4 mg) and 85.7% (6 mg) of HRS9531-treated participants achieved at least 5% weight loss...The trial results demonstrated a safety and tolerability profile consistent with GLP-1-based treatments....Most treatment-emergent adverse events (TEAEs) were mild to moderate and were gastrointestinal-related."

P3 data • Obesity

Hengrui Pharma and Kailera Therapeutics Announce Phase 3 HRS9531 Obesity Data Presentation at ObesityWeek 2025 (GlobeNewswire) - "The presentation will detail results from Hengrui’s Phase 3 clinical trial (GEMINI-1) conducted in China of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight."

P3 data • 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

Efficacy and safety of HRS9531, a novel dual GLP-1/GIP receptor agonist in Chinese overweight or obese adults without diabetes (EASD 2025) - P2 | "In overweight or obese adults without diabetes, once-weekly subcutaneous HRS9531 significantly reduced body weight at week 36 compared to placebo and demonstrated a manageable safety profile, primarily involving gastrointestinal disorders."

Clinical • Diabetes • Metabolic Disorders • Obesity

Hengrui Medicine: HRS9531 Injection's marketing application has been accepted by the National Medical Products Administration (NMPA). The high-dose group achieved an average weight loss of 19.2%. (Sina Corp)

China filing • Obesity

To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese (clinicaltrials.gov) - P3 | N=567 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Kailera | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

A Phase 1, single ascending dose study in healthy, overweight and obese participants to investigate safety, tolerability and pharmacokinetics of KAI-9531 subcutaneous injection (ANZCTR) - P1 | N=50 | Completed | Sponsor: Kailera Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Metabolic Disorders • Obesity

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hengrui Pharma and Kailera Therapeutics Report Positive Topline Data from Phase 3 Obesity Trial in China of Dual GLP-1/GIP Receptor Agonist HRS9531 (GlobeNewswire) - P3 | N=567 | NCT06396429 | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | "Hengrui...and Kailera...announced positive topline data from Hengrui’s Phase 3 clinical trial (HRS9531-301) of once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China (NCT06396429). The HRS9531-301 trial met both primary endpoints, including superior weight loss with HRS9531 (2 mg, 4 mg, and 6 mg) and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo at 48 weeks. Hengrui plans to submit a New Drug Application (NDA) for chronic weight management in China, and Kailera is advancing HRS9531 as KAI-9531 to global clinical trials...Based on the primary analysis (treatment policy estimand), participants taking HRS9531 achieved a mean weight loss of up to 17.7% (16.3% placebo-adjusted)...Hengrui intends to share....data at an upcoming scientific conference."

P3 data: top line • Obesity

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

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

A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices (clinicaltrials.gov) - P1 | N=51 | Not yet recruiting | Sponsor: Kailera

New P1 trial

Efficacy and Safety of a Novel Dual GLP-1/GLP Receptor Agonist in Chinese Overweight or Obese Adults without Diabetes (ADA 2025) - "In overweight or obese adults without diabetes, once-weekly subcutaneous HRS9531 significantly reduced BW at wk 36 compared to PBO and demonstrated a manageable safety profile, primarily involving gastrointestinal disorders."

Clinical • Diabetes • Metabolic Disorders • Obesity

Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist (HRS9531), in Obese Adults without Diabetes—Up to 52-Week Treatment (ADA 2025) - "HRS9531 treatment led to a notable reduction in BW compared to PBO over 32 wks in obese adults without diabetes. After 32 wks of treatment, Q2W dosing effectively maintained the achieved weight loss. Safety profile of HRS9531 was tolerable and manageable, consistent with other GLP-1/GIP RAs."

Clinical • Diabetes • Metabolic Disorders • Obesity

Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist in Participants with Type 2 Diabetes Mellitus Up to 32 Weeks (ADA 2025) - "This phase 2 study further evaluated the efficacy and safety of HRS9531 in Chinese T2DM participants with treatment to 32 weeks which consisted of a 20-week (W) core treatment followed by a 12W extension treatment. In this randomized, double-blind phase 2 trial, participants with T2DM, HbA1c 7.5%-10.5%, inadequately controlled with lifestyle or stable metformin, were randomized to receive QW subcutaneous HRS9531 (1, 2, 3 and 4.5 mg) and corresponding placebo. HRS9531 demonstrated improved and sustained glycemic control and weight loss over 32 weeks treatment, with a favorable safety and low risk of hypoglycemia."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects (clinicaltrials.gov) - P1 | N=57 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

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

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

HRS9531-302: the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone (clinicaltrials.gov) - P3 | N=218 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2026 ➔ May 2025

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

The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity