DR10624 / Huadong Medicine, Zhejiang Doer Biologics - LARVOL DELTA

Terminus-specific antibody development and bioanalytical assay validation to quantify active DR10624 in pharmacokinetic studies. (PubMed, Front Pharmacol) - "The validated dual-monoclonal ECL method provides a robust and specific approach for quantifying intact, bioactive DR10624 in human serum. This assay supports reliable PK assessment in ongoing and future clinical trials, facilitating the continued development of DR10624 for the treatment of MASLD/MASH, severe hypertriglyceridemia (SHTG), and related metabolic diseases."

Journal • PK/PD data • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Severe Hypertriglyceridemia • FGF21 • GCG

A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia (clinicaltrials.gov) - P3 | N=480 | Not yet recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd.

New P3 trial • Dyslipidemia • Hypertriglyceridemia • Severe Hypertriglyceridemia

A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia (clinicaltrials.gov) - P3 | N=378 | Not yet recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd.

New P3 trial • Dyslipidemia • Hypertriglyceridemia • 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 | Enrolling by invitation | Sponsor: Junbo Ge | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: May 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Atherosclerosis • Dyslipidemia • Hypertriglyceridemia

DR10624, a novel FGF21R/GCGR/GLP-1R triple agonist, significantly reduced liver fat and improved hepatic and metabolic biomarkers in a phase 2 study of patients with severe hypertriglyceridemia (EASL 2026) - "In patients with SHTG, treatment with DR10624 produced robust reductions in triglyceride levels and was associated with significant improvements in liver steatosis, hepatic function, and metabolic biomarkers. Collectively, these findings support DR10624 as a promising therapy for MASLD."

Biomarker • Clinical • P2 data • Dyslipidemia • Fibrosis • Hepatology • Hypertriglyceridemia • Immunology • Metabolic Dysfunction-Associated Steatotic Liver Disease • 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 | Enrolling by invitation | Sponsor: Junbo Ge | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Atherosclerosis • Dyslipidemia • Hypertriglyceridemia

Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: Zhejiang Doer Biologics Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia (clinicaltrials.gov) - P2 | N=79 | Completed | Sponsor: Zhejiang Doer Biologics Co., Ltd. | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Hypertriglyceridemia • Severe Hypertriglyceridemia

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2025 American Heart Association Scientific Sessions. (PubMed, Curr Atheroscler Rep) - "In a phase 2 trial, DR10624, a novel triple agonist, rapidly led to significant reductions in triglycerides and liver fat in patients with severe hypertriglyceridemia (sHTG). The CORE-TIMI 72a and CORE2-TIMI 72b trials showed that olezarsen markedly lowered triglycerides and reduced the risk of acute pancreatitis in patients with severe hypertriglyceridemia. The VESALIUS-CV trial demonstrated that evolocumab significantly lowered first major cardiovascular events in high-risk adults without prior myocardial infarction or stroke...Trials presented at the 2025 AHA Scientific Sessions emphasized new therapeutic, behavioral, and community-based strategies for cardiovascular disease risk reduction. These findings underscore a growing shift toward more effective and accessible approaches to improving cardiovascular health."

Journal • Review • Atrial Fibrillation • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Hypertriglyceridemia • Metabolic Disorders • Myocardial Infarction • Pancreatitis • Severe Hypertriglyceridemia

MTT.01: Meet the Trialists The CORE-TIMI 72a and CORE2-TIMI 72b Trials and DR10624, a First-In-Class, FGF21 Receptor/Glucagon Receptor/GLP-1 Receptor Triple Agonist (AHA 2025) - "Description: Meet the Trialists of Olezarsen in Patients with Severe Hypertriglyceridemia: The CORE-TIMI 72a and CORE2-TIMI 72b Trials and DR10624, a First-In-Class, FGF21 Receptor/Glucagon Receptor/GLP-1 Receptor Triple Agonist, Rapidly and Significantly Reduced Triglycerides, Atherogenic Lipids, and Liver Fat in Patients With Severe Hypertriglyceridemia: Primary Results From a Randomized Phase 2 Trial. This is not a CE accredited session. Panelist: Nicholas A Marston (Brigham And Womens Hospital)"

Dyslipidemia • Hypertriglyceridemia • Severe Hypertriglyceridemia • FGF21

New Drug Demonstrates Major Triglyceride Reductions and Liver Fat Improvements in Phase 2 Trial (Pharmacy Times) - "Preliminary data from a phase 2 clinical trial presented at the American Heart Association Scientific Sessions 2025....After 12 weeks, the results were striking: The 12.5 mg dose group showed a 74.5% reduction in triglycerides; The 25 mg dose group saw a 66.2% reduction, and the 50 mg titration group had a 68.9% reduction; The placebo group experienced only an 8% reduction. About 90% of patients that were given DR10624 managed to get their triglyceride levels down to less than 500 mg/dL, while only 25% of those who received a placebo showed such levels."

P2 data • Severe Hypertriglyceridemia

DR10624, a First-In-Class, FGF21 Receptor/Glucagon Receptor/GLP-1 Receptor Triple Agonist, Rapidly and Significantly Reduced Triglycerides, Atherogenic Lipids, and Liver Fat in Patients With Severe Hypertriglyceridemia: Primary Results From a Randomized Phase 2 Trial. (AHA 2025) - P2 | "DR10624 treatment significantly reduced TGs, atherogenic lipids, and liver fat in patients with STHG. This profound Phase 2 data underscore DR10624's strong potential as an innovative and promising treatment for SHTG."

Clinical • Late-breaking abstract • P2 data • Dyslipidemia • Hypertriglyceridemia • Obesity • Severe Hypertriglyceridemia • FGF21

Meet the Trialists of DR10624, a First-In-Class, FGF21 Receptor/Glucagon Receptor/GLP-1 Receptor Triple Agonist, Rapidly and Significantly Reduced Triglycerides, Atherogenic Lipids, and Liver Fat in Patients With Severe Hypertriglyceridemia: Primary Results From a Randomized Phase 2 Trial (AHA 2025) - No abstract available

Clinical • P2 data • Dyslipidemia • Hypertriglyceridemia • Severe Hypertriglyceridemia • FGF21

Huadong Medicine Secures FDA Approval for DR10624, First‑In‑Class Trispecific Agonist for Severe Hypertriglyceridemia (flcube.com) - "First step toward advancing DR10624 into U.S. phase‑I/II studies."

IND • New P1/2 trial • Severe Hypertriglyceridemia

Huadong Medicine will soon release the Phase II clinical data of DR10624 [Google translation] (Sina Corp) - "It is worth mentioning that the DR10624-201 study will be presented as the opening report at the main venue of 'AHA 2025.'"

P2 data • Severe Hypertriglyceridemia

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