conveglipron (HDM1002) / Huadong Medicine - LARVOL DELTA

To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=324 | Completed | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

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

A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

The clinical trial application of HDM1002 tablets of Huadong Medicine (000963.SZ) subsidiary was approved by the US FDA [Google translation] (Sina Corp) - "Huadong Medicine...issued an announcement that on July 22, 2025, the company's wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd...received a notice from the U.S. Food and Drug Administration (hereinafter referred to as 'U.S. FDA') that the clinical trial application for HDM1002 tablets submitted by Sino-US Huadong has been approved by the U.S. FDA."

IND • Obesity • Type 2 Diabetes Mellitus

First-in-human study of HDM1002, a GLP-1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers. (PubMed, Diabetes Obes Metab) - "HDM1002 was safe and well tolerated at 10-600 mg. HDM1002 showed linear pharmacokinetics, and a standardized high-fat meal did not impact systemic exposure. These results provide preliminary evidence supporting further clinical development of HDM1002 in individuals with type 2 diabetes."

Clinical • Journal • P1 data • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Significant weight reduction with improved body composition and serum TG/TC by HDM1002, a novel oral small molecule GLP-1R agonist (EASD 2025) - "HDM1002 is a potent, orally bioavailable, and cAMP-biased GLP-1R small molecule full agonist. Preclinical studies demonstrate that HDM1002 effectively promotes weight loss by reducing fat body mass while preserving lean body mass, and significantly improves serum cholesterol and triglyceride levels. These findings suggest that HDM1002 may serve as a promising therapeutic option for obesity."

Metabolic Disorders • Obesity • LEP

Innovation and breakthrough, three major GLP-1 drugs shine at ADA conference [Google translation] (Sohu.com) - P1 | N=72 | NCT06520540 | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | "HDM1002 is a novel, oral non-peptide GLP-1 receptor agonist. In this Phase 1b double-blind, placebo-controlled, multiple-dose escalation study, 60 Chinese overweight or obese subjects were included. The study showed that HDM1002 has good safety and tolerability, and doses of 200 mg and above have a significant weight loss effect. This study supports the further clinical development of HDM1002 in overweight or obesity indications. It is worth mentioning that the results of the study showed that most adverse events (AEs) of HDM1002 were mild or moderate, no serious TEAEs were reported, and no AEs related to elevated liver enzymes were reported in all dose groups."

P1 data • Obesity

HDM1002 in Chinese Adults with Overweight or Obesity—A Randomized, Placebo-Controlled, Four-Week, Phase 1b Study (ADA 2025) - "HDM1002 demonstrated an acceptable safety profile and favorable PK profiles. Significant body weight reduction from placebo has been observed for 28 days treatment, which supports further clinical development of HDM1002 in overweight or obesity indication."

Clinical • P1 data • Metabolic Disorders • Obesity

A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Hepatology

Huadong Medicine: HDM1002 is expected to start Phase III clinical study for weight management indication in the country this month [Google translation] (Eastmoney.com) - "Huadong Medicine(000963.SZ) stated on the investor interaction platform on March 12 that HDM1002 is expected to start Phase III clinical research for weight management indications in China this month."

New P3 trial • Obesity

Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults (clinicaltrials.gov) - P3 | N=780 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Obesity

A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects. (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Obesity

A Relative Bioavailability and Food Effect Study of HDM1002 in Healthy Subjects (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial

A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial

A Drug-Drug Interaction (DDI) Study of HDM1002 With Rifampicin and Itraconazole in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial

HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Obesity

Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=318 | Not yet recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Discovery of HDM1002, a selective, potent, oral small-molecule GLP-1R agonist for treatment of type 2 diabetes and obesity (EASD 2023) - "In summary, we roport the preclinical data of HDM1002, a selective, potent, oral small-molecule GLP-1R agonist administered in participants with T2D. HDM1002 had a favorable safety and tolerability profile, which was generally consistent with the peptidic GLP-1R agonist class. The results of this study support further clinical development of HDM1002 for the treatment of T2D and obesity."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

The “magic drug for weight loss” has become the king of European market capitalization, competition among Chinese pharmaceutical companies has accelerated, and 8 generic drugs have been clinically accepted during the year [Google translation] (36Kr) - "...Huadong Medicine...announced that the clinical trial application for HDM1002 tablets submitted by its wholly-owned subsidiary Sino-American Huadong was approved by the National Medical Products Administration (NMPA). According to the announcement, the drug is an oral small molecule GLP-1 receptor agonist, and its indication is for weight management in overweight or obese people."

New trial • Metabolic Disorders • Obesity