conveglipron (HDM1002) / Huadong Medicine - LARVOL DELTA

Pharmacokinetics and Food Effect of HDM1002, a Novel Oral Small-Molecule GLP-1 Receptor Agonist, in Healthy Chinese Volunteers: A Bioequivalence Study. (PubMed, Diabetes Obes Metab) - P1 | "HDM1002 was well-tolerated and safe. The two tablet strengths (100 and 200 mg) were bioequivalent under fasting conditions. A high-fat meal modestly reduced the Cmax of the 200-mg tablet but did not significantly affect its overall exposure (AUC)."

Journal • PK/PD data

Significant Synergistic Effects in Diabetic Kidney Disease by HDM1010 (ADA 2026) - "Here, we investigated the potential synergistic renoprotective effects of HDM1010, which is a combination product of HDM1002 and SGLT2i in a type 2 diabetes mellitus kidney disease (T2DKD) mouse model. After a 12-week induction of T2DKD with a high-fat diet followed with an i.p. injection of streptozotocin, mice were treated with daily oral gavage of HDM1002 (20 or 40 mg/kg), and SGLT2i (10 mg/kg), or their combinations for 10 weeks... Collectively, HDM1010 exhibited more potent effect on blood glucose control, and demonstrated a synergistic improvement in renal function comparing with either monotherapy. Investigational new drug application has been prepared for further clinical development."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of a Novel Oral Small Molecule GLP-1 Receptor Agonist HDM1002 in Chinese Overweight and Obese Adults: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial (ADA 2026) - P2 | "In obese adults without diabetes, HDM1002 showed statistically significant reductions in BW at wk 12 compared with PBO, and exhibited an acceptable safety profile consistent with other GLP-1 RAs."

Clinical • P2 data • Diabetes • Metabolic Disorders • Obesity

Significant Synergistic Hypoglycemic Effects in Type 2 Diabetes Mellitus by HDM1010 (ADA 2026) - "Here, we investigated the potential synergistic hypoglycemic effects of HDM1010, which is a combination product of HDM1002 and SGLT-2i in a T2DM mouse model. After the induction of T2DM with a high-fat diet followed with i.p. injection of streptozotocin, the humanized GLP-1R (C57BL/6J) transgenic mice were treated with daily oral gavage of HDM1002 (20 or 40 mg/kg), and SGLT-2i (1 or 5 mg/kg), or their combinations for 28 days... Collectively, HDM1010 exhibits a faster, more optimal, and more stable effect on blood glucose control, which indicates its superiority. Investigational new drug application has been approved by FDA."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of a Novel Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist (HDM1002) in Type 2 Diabetes Mellitus Patients Inadequately Controlled on Diet and Exercise or Metformin (ADA 2026) - "HDM1002 significantly reduced HbA1c in Chinese pts with T2DM inadequately controlled on D&E or Met. The safety profile supported further development of HDM1002 as an oral treatment option for T2DM."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial

HDM1002 in Chinese Adults With Overweight/Obesity: A Randomized, Placebo-Controlled, Ascending-Dose Phase 1b Study. (PubMed, Obesity (Silver Spring)) - "HDM1002 demonstrated a manageable safety/tolerability profile."

Journal • P1 data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A single-center, randomized, open, cross-sectional clinical study evaluating pharmacokinetic characteristics, relative bioavailability, and food effects of HDM1002 tablets of different specifications (ChiCTR) - P1 | N=33 | Completed | Sponsor: Hangzhou First People's Hospital; Hangzhou Sino-American East China Pharmaceutical Co., LTD

New P1 trial • Diabetes • Metabolic Disorders

A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P1 trial • Obesity

Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

New P3 trial • 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

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

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

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

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