Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects (NCT07024212) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Presence of cirrhosis on liver biopsy or imaging results, or have a history of cirrhosis;
. Other causes of liver disease based on medical history and/or laboratory tests;
. Previous (within 5 years before randomization) or planned (during the study period) obesity treatment with metabolic surgery or device-based therapy subjects with reversible weight-loss devices removed more than 12 months prior to randomization are eligible;
. Type 1 diabetes;
. History of malignancies within the last 5 years prior to screening, or malignancies that occurred more than 5 years ago but which are still currently active. Local squamous cell carcinoma of the skin or cervical intraepithelial neoplasia that has been cured without signs of recurrence is acceptable;
. Presence of severe or uncontrolled underlying disease that, in the opinion of the investigator, renders the subject unsuitable for treatment with the investigational medicinal product or unable to complete study, or is likely to interfere with the evaluation of study results;
. Subjects who have a history of bone trauma, fracture, or bone surgery within 2 months prior to screening, or concomitant bone disorders such as osteomalacia or known, untreated severe vitamin D deficiency (serum 25-hydroxyvitamin D ≤5 ng/mL); or a T-score ≤-2.5 for bone mineral density measured by DXA in the axial skeleton (lumbar vertebrae 1-4, femur neck, or total hip);
. Subjects who have a history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or a related family history;