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

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

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

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