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

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

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

New P2a trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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

New P2 trial • Genetic Disorders • Obesity

A Study of HS-20094 in Healthy Participants (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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