MedTrace Logo

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

NCT07024212 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-29

No results posted yet for this study

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

DRUG

DR10624 Injection

Drug: DR10624 injection

DRUG

Placebo

Drug: Placebo

Sponsors & Collaborators

  • Zhejiang Doer Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Vincent Wai-Sun Wong, M.D. · Prince of Wales Hospital, The Chinese University of Hong Kong

  • Junping Shi, M.D. · The Affiliated Hospital of Hangzhou Normal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2026-05-30
Completion
2026-08-30

Countries

  • China
  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024212 on ClinicalTrials.gov