olatorepatide (HS-20094) / Jiangsu Hansoh Pharma, Regeneron - LARVOL DELTA

Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Dermatology • Genetic Disorders • Hidradenitis Suppurativa • Immunology • Obesity

Efficacy and safety of olatorepatide, a novel dual-biased GLP-1/GIP receptor agonist in Chinese adults with overweight or obesity: a randomised, double-blind, placebo-controlled, phase 3 study (EASD 2026) - P3 | "In Chinese adults with overweight or obesity, Olatorepatide demonstrated substantial BW reduction without observed plateau at week 48, indicating potential for further efficacy with extended treatment. Olatorepatide also brought meaningful improvements in metabolic health, along with an exemplary safety profile, supporting its potential as a novel therapy for weight management."

Clinical • Late-breaking abstract • P3 data • Metabolic Disorders • Obesity

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

HS-20094 (olatorepatide): A Dual Biased GLP-1 and GIP Receptor Agonist for Obesity (ENDO 2026) - P3 | "These characteristics conferred upon HS-20094 the potential to achieve robust body weight reduction efficacy while maintaining a low incidence of nausea and vomiting. Currently, HS-20094 has completed the Phase 3 clinical trial for the treatment of overweight or obesity (NCT06839664) in Chinese adults."

Late-breaking abstract • Genetic Disorders • Obesity • ARRB1

A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Study of HS-20094 in Chinese Adults With Overweight or Obesity (clinicaltrials.gov) - P3 | N=604 | Completed | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Hansoh Pharmaceutical…is pleased to announce that on June 3, 2026, the New Drug Application (NDA) of the Group’s innovative drug Olatorepatide Injection has been accepted by the National Medical Products Administration (NMPA) of China for chronic weight management in obese or overweight adult patients (HKEXnews)

China filing • Obesity

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Hansoh Pharmaceutical Group Company Limited…announced positive Phase 3 results for olatorepatide (HS-20094), an investigational once-weekly GLP-1/GIP receptor dual agonist, in adults with obesity or overweight (Hansoh Pharma Press Release) - "The randomized, double-blind, placebo-controlled study enrolled 604 adults across 33 clinical sites and evaluated once-weekly olatorepatide versus placebo over 48 weeks. The study met its co-primary endpoints, demonstrating a statistically significant reduction in body weight from baseline at Week 48 and a statistically significantly greater proportion of participants achieving at least 5% weight loss at Week 48 with olatorepatide versus placebo. Participants treated with olatorepatide achieved up to 19.3% mean weight loss from baseline at Week 48. Responder analyses showed that up to 97.2% of participants achieved ≥5% weight loss at Week 48.....Detailed results from this Phase 3 study are planned to be presented at an upcoming international medical conference and submitted for publication in a peer-reviewed scientific journal."

P3 data • Obesity

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Genetic Disorders • Obesity

A Phase 3 Study of HS-20094 in Patients With T2DM (clinicaltrials.gov) - P3 | N=546 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone (clinicaltrials.gov) - P3 | N=204 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

A Study of HS-20094 in Overweight or Obese Participants (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

A Study of HS-20094 in T2DM Participants (clinicaltrials.gov) - P2 | N=54 | Completed | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Phase classification: P2a ➔ P2 | N=96 ➔ 54

Enrollment change • Phase classification • Trial completion • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of HS-20094 in Patients With T2DM (clinicaltrials.gov) - P2 | N=275 | Completed | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Apr 2025 | Trial primary completion date: Aug 2025 ➔ Mar 2025

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

Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-Licensing of Novel Dual GLP-1/GIP Receptor Agonist (GlobeNewswire) - "Regeneron Pharmaceuticals, Inc...announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited ('Hansoh') to acquire exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. This novel therapeutic candidate (HS-20094) – studied in over 1,000 patients and administered as a weekly subcutaneous injection – has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist....Under the terms of the agreement, Regeneron will make an upfront payment to Hansoh of $80 million, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Future potential royalties for global net sales outside of the designated territories would be in the low double digits."

Licensing / partnership • Diabetes • Obesity

A Study of HS-20094 in Patients With T2DM (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

A Study of HS-20094 in Chinese Adults with Overweight or Obesity (clinicaltrials.gov) - P3 | N=610 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Obesity

Efficacy and safety of HS-20094 in patients with type 2 diabetes: a randomised double-blind, placebo-controlled, phase 2 trail (EASD 2024) - P2a | "Efficacy results between groups were compared using analysis of covariance (ANCOVA) with baseline value as a covariate and status of metformin use as a fixed effect... In patients with T2DM, HS-20094 was generally safe and showed meaningful HbA 1c , fasting blood glucose and body weight reductions."

Clinical • P2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Hansoh Pharmaceuticals released data from Phase II clinical study of GLP-1R/GIPR dual-target agonist at the American Diabetes Annual Meeting [Google translation] (China Economic Net (CE.cn)) - P2 | N=96 | NCT06118008 | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | "From June 21 to 24, the 2024 American Diabetes Annual Meeting...was held in Orlando, the United States. The Phase II clinical study data of Hansoh Pharmaceutical's HS-20094...was released at the conference in the form of a poster + electronic poster and live Q&A....The Phase II study results of HS-20094 published this time showed that HS-20094 has good safety and tolerability characteristics in subjects with type 2 diabetes, and exhibits excellent blood sugar-lowering and weight-reducing effects. Research data show that in diabetic patients, HS-20094 is safe and well tolerated within the dosage range of 5 to 15 mg, and is significantly superior to the placebo group in terms of blood sugar lowering and weight loss efficacy. Compared with semaglutide, the 15 mg dose of HS-20094 has significant advantages in terms of blood sugar lowering and weight loss efficacy."

P2 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of HS-20094 in Patients with Type 2 Diabetes—A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial (ADA 2024) - P2a | "Patients with T2DM poorly controlled with diet and exercise alone or with stable metformin (HbA1c ≥7.0 to ≤10.0%) were randomly (4:1:1) assigned within each cohort to receive HS-20094 (5mg, 10mg or 15mg), semaglutide (1.0mg), or placebo subcutaneously once-weekly... In patients with T2DM, HS-20094 was generally safe and showed meaningful HbA1c, fasting blood glucose and body weight reductions."

Clinical • P2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Efficacy and Safety of HS-20094 in Patients with Type 2 Diabetes—A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial (ADA 2024) - P2a | "Patients with T2DM poorly controlled with diet and exercise alone or with stable metformin (HbA1c ≥7.0 to ≤10.0%) were randomly (4:1:1) assigned within each cohort to receive HS-20094 (5mg, 10mg or 15mg), semaglutide (1.0mg), or placebo subcutaneously once-weekly... In patients with T2DM, HS-20094 was generally safe and showed meaningful HbA1c, fasting blood glucose and body weight reductions."

Clinical • P2 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Phase I clinical study data of Hansoh Pharma's GLP-1R/GIPR dual-target agonist were released at the International Diabetes Federation Congress [Google translation] (China Economic Net (CE.cn)) - P1 | N=NA | "The phase I clinical study data of Hansoh Pharmaceuticals HS-20094 (GLP-1R/GIPR dual target agonist) was presented in the form of poster and oral reports. Conference release. Research results show that HS-20094 has good safety and tolerability characteristics in healthy subjects, and shows significant signs of reducing blood sugar and weight.

P1 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus