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Studies

Interventional Active not recruiting Phase 2

NCT07024212 on ClinicalTrials.gov

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

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

  • Sponsor: Zhejiang Doer Biologics Co., Ltd.
  • Enrollment: 110 (Estimated)
  • Study start: 2025-04-22 (Actual)
  • Primary completion: 2026-06-18 (Actual)
  • Study completion: 2026-09-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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

Intervention / Treatment

  • Drug: DR10624 Injection
  • Drug: Placebo

Primary Outcome Measures

  • Changes of LFC (From baseline to Week 12)
    Relative percentage changes (%) of Liver Fat Content (LFC) from baseline to Week 12, assessed by MRI-PDFF.

Countries

China, Hong Kong

Locations and Investigators

  • The Affiliated Hospital of Hangzhou Normal University, Hangzhou, 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

Study Officials