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

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.

NCT Number	NCT07024212
Lead Sponsor	Zhejiang Doer Biologics Co., Ltd.
Conditions	MASLD
Enrollment	110 participants
Start Date	2025-04-22
Primary Completion	2026-06-18 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-07