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

NCT07024212 | Active Not Recruiting Phase 2

• 1 other identifier: DR10624-202
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 4

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

Keywords

NASH; MASH; NAFLD; MAFLD

Outcome Measures

Primary Outcomes (1)

• Changes of LFC

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

  From baseline to Week 12

Secondary Outcomes (18)

• Changes of Controlled Attenuation Parameter (CAP)

  From baseline to Week 12

• Changes of Liver Stiffness Measurement (LSM)

  From baseline to Week 12

• Changes of LFC

  From baseline to Week 12

• Proportion of subjects achieving a relative reduction of LFC

  From baseline to Week 12

• Proportion of subjects with LFC <5%

  From baseline to Week 12

Study Arms (5)

Cohort 1：DR10624 injection/Placebo (SC, qw)

EXPERIMENTAL

DR10624 injection/Placebo (SC, qw)

Drug: DR10624 Injection; Drug: Placebo

Cohort 2：DR10624 injection/Placebo (SC, qw)

EXPERIMENTAL

DR10624 injection/Placebo (SC, qw)

Drug: DR10624 Injection; Drug: Placebo

Cohort 3：DR10624 injection/Placebo (SC, qw)

EXPERIMENTAL

DR10624 injection/Placebo (SC, qw)

Drug: DR10624 Injection; Drug: Placebo

Cohort 4：DR10624 injection/Placebo (SC, qw)

EXPERIMENTAL

DR10624 injection/Placebo (SC, qw)

Drug: DR10624 Injection; Drug: Placebo

Cohort 5：DR10624 injection/Placebo (SC, qw)

EXPERIMENTAL

DR10624 injection/Placebo (SC, qw)

Drug: DR10624 Injection; Drug: Placebo

Interventions

DR10624 Injection DRUG

Drug: DR10624 injection

Cohort 1：DR10624 injection/Placebo (SC, qw); Cohort 2：DR10624 injection/Placebo (SC, qw); Cohort 3：DR10624 injection/Placebo (SC, qw); Cohort 4：DR10624 injection/Placebo (SC, qw); Cohort 5：DR10624 injection/Placebo (SC, qw)

Placebo DRUG

Drug: Placebo

Cohort 1：DR10624 injection/Placebo (SC, qw); Cohort 2：DR10624 injection/Placebo (SC, qw); Cohort 3：DR10624 injection/Placebo (SC, qw); Cohort 4：DR10624 injection/Placebo (SC, qw); Cohort 5：DR10624 injection/Placebo (SC, qw)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• Any significant abnormal laboratory findings from screening to randomization;
• Subjects who have used or plan to use the following medications that may cause steatosis/steatohepatitis cumulatively for ≥4 weeks within 24 weeks prior to randomization or during the study: amiodarone, methotrexate, systemic corticosteroids (dose \>5 mg/day prednisone equivalent), estrogens (dose greater than that used for hormone replacement therapy or contraception), tetracyclines, tamoxifen, anabolic steroids, valproic acid, or other drugs known to have hepatotoxicity, etc.;
• Use of any of the following medications cumulatively for ≥4 weeks within 24 weeks prior to randomization or planned during the study: high-dose vitamin E (daily dose \>400 IU), obeticholic acid, pioglitazone, berberine, or thyroid hormones (subjects with hypothyroidism who have received stable replacement therapy for at least 3 months prior to randomization are acceptable), etc.;
• Use of antidiabetic drugs other than metformin, sulfonylureas, alpha-glucosidase inhibitors, glucokinase activators (GKA), or sodium-glucose cotransporter 2 (SGLT-2) inhibitors within 12 weeks prior to screening or planned during the study;
• Use of Schisandra preparations (e.g., bifendate, bicyclol) within 6 weeks prior to randomization, or use of the following hepatoprotective drugs (including but not limited to reduced glutathione, glucuronolactone, glycyrrhizic acid preparations, polyene phosphatidylcholine, ursodeoxycholic acid, nicotinamide, liver-protecting tablets, silymarin, etc.) or other hepatoprotective Chinese proprietary medicines or health products within 2 weeks prior to randomization; or planned use of such drugs during the study;
• Use of weight-loss drugs such as orlistat or GLP-1 receptor agonists, or other drugs with the same target as the investigational medicinal product \[e.g., fibroblast growth factor-21 (FGF21) analogs, glucagon receptor (GCGR) agonists, etc.\], within 6 weeks prior to screening or planned during the study;
• Use of anti-tumor necrosis factor α (TNF-α) drugs, such as adalimumab or etanercept, etc., within 6 weeks prior to screening or planned during the study;

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (4)

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Location

The First Hospital of Jilin University

Changchun, China

Location

Nanjing Gulou Hospital

Nanjing, China

Location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Vincent Wai-Sun Wong, M.D.

  Prince of Wales Hospital, The Chinese University of Hong Kong

  STUDY CHAIR

• Junping Shi, M.D.

  The Affiliated Hospital of Hangzhou Normal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: June 17, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (3); HK (1)