Active — Not RecruitingPhase 2

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

China, Hong Kong110 participantsStarted 2025-04-22

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Subjects who have signed the informed consent form before the trial, and fully understood the trial content, process and possible adverse reactions;
✓. Males or females aged 18-75 years (inclusive) at the time of signing the informed consent form;
✓. LFC ≥ 10% assessed by MRI-PDFF (MRI-PDFF results that are obtained at the study site within 6 weeks prior to randomization are acceptable);
✓. Screening FibroScan® with liver stiffness (LSM): ≥ 8 Kpa, and \< 15 Kpa;
✓. Have a body mass index (BMI) between 25.0 and 40.0 kg/m2 (inclusive) at screening;
✓. Less than 5% change in body weight within 6 months prior to randomization;
✓. If there is a history of type 2 diabetes, a stable treatment regimen must be maintained for at least 12 weeks prior to screening;
✓. Females of childbearing potential and males must agree to use effective contraception during the study and for a specified period after the last dose of the investigational medicinal product (2 months for females, 3 months for males).

Exclusion criteria

What they're measuring

Changes of LFC

Timeframe: From baseline to Week 12

Trial details

NCT IDNCT07024212

SponsorZhejiang Doer Biologics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-30

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