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ACTIVE NOT RECRUITING
NCT07024212
PHASE2

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

Sponsor: Zhejiang Doer Biologics Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-04-22

Completion Date

2026-08-30

Last Updated

2026-01-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

DR10624 Injection

Drug: DR10624 injection

DRUG

Placebo

Drug: Placebo

Locations (4)

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

The First Hospital of Jilin University

Changchun, China

Nanjing Gulou Hospital

Nanjing, China

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong