DR10624 / Huadong Medicine - LARVOL DELTA

Huadong Medicine: Doerr Biopharma's triple agonist DR10627 completes Phase 1 clinical trial [Google translation] (163.com) - "The product under development DR10627 of the company's holding subsidiary Doer Bio is a triple agonist targeting GLP-1R/GIPR/GCGR, and has completed Phase 1 clinical trials. In addition, Doer Bio's FGF21R/GCGR/GLP-1R triple-target agonist DR10624 is currently conducting a Phase II clinical study for the treatment of metabolic-related fatty liver disease with a high risk of liver fibrosis and metabolic-related alcohol-related fatty liver disease, and the first subject will be enrolled in April 2025. At the same time, another Phase II clinical study of DR10624 for the treatment of severe hypertriglyceridemia, which has been launched, has completed the enrollment of all patients."

Trial completion • Trial status • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Severe Hypertriglyceridemia

A Trial to Evaluate the Efficacy and Safety of DR10624 in Patients With Hypertriglyceridemia and Carotid Atherosclerotic Plaque (clinicaltrials.gov) - P=N/A | N=40 | Not yet recruiting | Sponsor: Junbo Ge

New trial • Atherosclerosis • Dyslipidemia • Hypertriglyceridemia

Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd.

New P2 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

DR10624, a first-in-class, FGF21 receptor (FGF21R)/glucagon receptor (GCGR)/GLP-1 receptor (GLP-1R) triple agonist rapidly and significantly reduced liver fat in obese subjects with modest hypertriglyceridemia: a 12-week randomized, placebo-controlled, double-blind, multi-center trial (EASL 2025) - "DR10624, administered weekly for 12 weeks, resulted in rapid and clinically significant reduction in liver fat, along with remarkable improvements in lipid profiles and insulin sensitivity. The Phase 2a data further underscore DR10624's strong potential as an innovative and promising treatment for MASLD/MASH."

Clinical • Late-breaking abstract • Dyslipidemia • Hepatology • Hypertriglyceridemia • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • FGF21

Doer Biologics Announces First Patient Dosed in Phase 2 Study of DR10624 for Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis (PRNewswire) - "Zhejiang Doer Biologics...today announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon receptor (GCGR), and Glucagon-like peptide-1 receptor (GLP-1R) has completed the dosing of the first patient in the Phase 2 study of DR10624 for the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH)....The primary endpoint of this study is relative percentage change from baseline in LFC, as measured by MRI-PDFF after 12 weeks of treatment."

Trial status • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

DR10624, a novel FGF21R, GCGR, and GLP-1R tri-agonist, demonstrated extraordinary efficacy in B6-Alms1-del mice, a spontaneous MASH model of mice with obesity, hyperglycemia, and dyslipidemia phenotype (EASL 2025) - "DR10624 significantly improved liver pathology in B6-Alms1-del mice, a spontaneous MASH model of mice. It also effectively reduced body weight, improved liver and blood lipid profiles, and ameliorated liver function, which all outperformed Semaglutide. DR10624's preclinical study demonstrated its great potential as a possible best-in-class biotherapy for the treatment of MASH patients."

Preclinical • Diabetes • Dyslipidemia • Fibrosis • Genetic Disorders • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Doer Biologics Completes Enrollment of the Phase 2 Clinical Study of DR10624 for Treatment of Severe Hypertriglyceridemia (PRNewswire) - "Zhejiang Doer Biologics...announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon receptor (GCGR), Glucagon-like peptide-1 receptor (GLP-1R) has completed the enrollment in the Phase 2 clinical study of DR10624 for the treatment of severe hypertriglyceridemia (SHTG) ('DR10624-201 study'). The DR10624-201 study is a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of three dose levels of DR10624 in adult SHTG patients, who have mean fasting triglycerides of greater than or equal to 5.65 mmol/L (500 mg/dL) at screening. A total of 79 SHTG patients have been enrolled in the 12 weeks study....'The topline data is expected in the third quarter of 2025'."

Enrollment closed • P2 data • Severe Hypertriglyceridemia

DR10624-101: A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624 (clinicaltrials.gov) - P1 | N=153 | Completed | Sponsor: Zhejiang Doer Biologics Co., Ltd. | Recruiting ➔ Completed | N=104 ➔ 153

Enrollment change • Trial completion • Genetic Disorders • Obesity

A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd.

New P2 trial • Dyslipidemia • Hypertriglyceridemia • Severe Hypertriglyceridemia

Zhejiang Doer Biologics Completes Enrollment of the Phase 1b/2a Trial Evaluating DR10624 in Obese Subjects with Modest Hypertriglyceridemia (PRNewswire) - "Zhejiang Doer Biologics...today announces that the company has completed the enrollment in the Phase 1b/2a trial evaluating DR10624 in obese subjects with modest hypertriglyceridemia in New Zealand. DR10624 is a first-in-class (FIC), long-acting tri-specific agonist targeting Fibroblast growth factor 21 receptor (FGF21R), Glucagon-like peptide-1 receptor (GLP-1R), and Glucagon receptor (GCGR)...We anticipate reporting the trial results in early 2025."

Enrollment closed • P1/2 data • Metabolic Disorders • Obesity

A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624 (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd.

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Huadong Medicine: Subsidiary completes dosing of first cohort of subjects in China Phase I clinical trial of DR10624 [Google translation] (Daily Economic News - NBD) - "...the company’s holding subsidiary Zhejiang Daoer Biotechnology Co., Ltd...announced its global. The first three-target multi-specific innovative drug DR10624 has completed the first cohort (12 subjects in total) of the Phase I single ascending dose (SAD) clinical trial in China for weight management indications in overweight or obese people. (or) administer medication."

Trial status • Metabolic Disorders • Obesity

Doer Biologics Announces First Subject Dosed in Phase I 12-Week Multiple-Ascending Dose (MAD) Clinical Trial of DR10624 and Received IND Approval From NMPA (PRNewswire) - "Zhejiang Doer Biologics Co., Ltd...announces that DR10624, its first-in-class (FIC), tri-specific agonist targeting Glucagon-like peptide-1 receptor (GLP-1R), Glucagon receptor (GCGR), and Fibroblast growth factor 21 receptor (FGF21R), has completed the dosing of the first subject in the Phase Ib 12-week Multiple-Ascending Dose (MAD) study of DR10624 for the treatment of obesity and hypertriglyceridemia in New Zealand....Doer Bio also announces that it has recently received the IND approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for DR10624 for the treatment of obesity in China."

New trial • Trial status • Metabolic Disorders • Obesity

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-and Multiple-Ascending Subcutaneous Doses of DR10624 (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-and Multiple-Ascending Subcutaneous Doses of DR10624 (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Zhejiang Doer Biologics Corporation

New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus