NCT07024212

Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of DR10624 Injection in Subjects at High Risk of Liver Fibrosis With Metabolic Dysfunction-associated Steatotic Liver Disease and Metabolic Dysfunction and Alcohol Associated Steatotic Liver Disease

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Zhejiang Doer Biologics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II clinical trial that consists of two parts. The primary objective of Part 1 is to assess the preliminary efficacy of DR10624 Injection in MASLD subjects at high risk of liver fibrosis. The secondary objectives are to assess the safety and tolerability, PK profiles, and immunogenicity of DR10624 Injection in these subjects. The exploratory objectives are to assess the efficacy of DR10624 Injection in these subjects using LSM assessed by MRE, and its impact on Lp(a) and body composition.The primary objective of Part 2 is to assess the safety and tolerability of DR10624 Injection in MetALD subjects at high risk of liver fibrosis. This clinical trial is currently only conducting Part 1 of the study.

Conditions

• MASLD

Interventions

Type	Name	Description
DRUG	DR10624 Injection	Drug: DR10624 injection
DRUG	Placebo	Drug: Placebo

Timeline

• Start date: 2025-04-22
• Primary completion: 2026-05-30
• Completion: 2026-08-30
• First posted: 2025-06-17
• Last updated: 2026-01-29

Locations

4 sites across 2 countries: China, Hong Kong