poterepatide (HDM-1005) / Huadong Medicine - LARVOL DELTA

A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites (clinicaltrials.gov) - P1 | N=135 | Active, not recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

A phase 2 trial of HDM1005 in participants with type 2 diabetes not controlled with diet/exercise or metformin (EASD 2026) - P2 | "Chinese adults with T2D inadequately controlled by diet/exercise with or without metformin monotherapy (HbA1c 7.0-10.5%) were randomized to receive once-weekly subcutaneous HDM1005 (0.5, 1.0, 2.0, or 3.0 mg), placebo, or open-label Dulaglutide (1.5 mg) for 20 weeks. In patients with T2D, HDM1005 treatment for 20 weeks resulted in significant, dose-dependent improvements in glycemic control and body weight, with a favorable safety profile, supporting further development as a promising dual GLP-1/GIP receptor agonist for metabolic disease."

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

Phase Ib Clinical Study of HDM1005 Injection (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | N=40 ➔ 80

Enrollment change • Genetic Disorders • Obesity

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Preclinical Efficacy and Safety of HDM1014, a Novel GalNAc-siRNA Targeting INHBE, for Weight Management with Muscle Preservation (ADA 2026) - "Weight-loss efficacy was evaluated in DIO-hINHBE mice treated with HDM1014 alone or combined with HDM1005 (a GLP-1R/GIPR agonist developed by the company)... HDM1014 exhibits a potential best-in-class profile with robust and durable INHBE inhibition with significant fat-selective weight loss and full preservation of lean mass. Favorable safety margin was conformed based on available toxicity studies."

Preclinical • Metabolic Disorders • PPARG • TGFB1

Efficacy and Safety of Dual GLP-1/GIP Receptor Agonist HDM1005 in Obese Participants without Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial (ADA 2026) - P2 | "HDM1005 showed clinically meaningful dose-dependent weight loss, and improved blood pressure, blood glucose and lipid profiles, with excellent safety and tolerability in Chinese adults with obesity."

Clinical • P2 data • Diabetes • Metabolic Disorders • Obesity

Discovery of a High-Potency Balanced GLP-1/GIP Dual Agonist by Molecular Dynamics Evolution. (PubMed, J Med Chem) - "It exhibited a favorable safety profile with a NOAEL of 5 mg/kg. With enhanced receptor binding, extended pharmacodynamic activity, and superior efficacy, HDM1005 represents a potential best-in-class therapeutic agent for metabolic disorders."

Journal • Metabolic Disorders • Obesity

A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Obesity

Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes (clinicaltrials.gov) - P2 | N=372 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor (clinicaltrials.gov) - P3 | N=912 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes (clinicaltrials.gov) - P3 | N=825 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Significant weight reduction with improved body composition by HDM1005, a novel long-acting GLP-1R/GIPR dual agonist (EASD 2025) - "Supported by none Clinical Trial Registration Number: N/A Background and aims: HDM1005 is a dual GLP-1 and GIP receptor agonist, which potently activates GLP-1R and GIPR in vitro, and has demonstrated superior body weight reduction compared to Tirzepatide at equivalent doses in a diet-induced obesity (DIO) mouse model. Collectively, HDM1005 achieves significant weight loss primarily through fat mass reduction (contribution to total weight loss: 81.58%). Notably, HDM1005 also exhibits promising therapeutic potential for MASH, highlighting its dual benefit in metabolic disease management."

Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Phase 2 Trial of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin (clinicaltrials.gov) - P2 | N=216 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Huadong Medicine Achieves Key Progress in Global Patent Licensing for HDM1005, a Self-Developed Innovative GLP-1R/GIPR Dual-Target Agonist [Google translation] (Sina Corp) - "Recently, the patent licensing of HDM1005, an innovative peptide-based long-acting agonist targeting both the human GLP-1 (Glucagon-like peptide-1) receptor and the GIP (Glucose-dependent insulinotropic polypeptide) receptor, developed by Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd....The molecular patent for HDM1005 has been dually authorized by the China National Intellectual Property Administration (CNIPA) and the United States Patent and Trademark Office (USPTO), and intellectual property protection has been laid out for the synthesis process, formulation, indications and other generic uses."

Patent • Diabetes • Obesity

Phase Ib Clinical Study of HDM1005 Injection (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of a Dual GLP-1/GIP Receptor Agonist (HDM1005)—A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study (ADA 2025) - P1 | "HDM1005 was well tolerated, had favorable PK, and led to promising body weight reduction and improvements in OGTT AUC0-2h and lipid profiles. Phase II studies of HDM1005 in obesity and T2DM are currently ongoing."

Clinical • PK/PD data • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Phase II Clinical Study of HDM1005 Injection in Obese Adults Without Diabetes Mellitus (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Huadong Medicine HDM1005 Injection Approved to Conduct Clinical Trial on OSA and Obesity Patients [Google translation] (new.qq.com) - "According to the latest news from Radar Finance, Huadong Medicine (000963)'s wholly-owned subsidiary Sino-US Huadong received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration (NMPA) on February 24, 2025, approving the use of HDM1005 injection for clinical trials in obstructive sleep apnea (OSA) and obese or overweight adult patients."

New trial • Obesity • Obstructive Sleep Apnea