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MASLDPhase 2NCT07024212

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

A Phase 2 study testing DR10624 Injection in people with MASLD, run by Zhejiang Doer Biologics Co., Ltd. at 4 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
MASLD
What is being tested?
DR10624 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
4 sitesin 2 countries
Study dates
22 Apr 2025to 30 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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;
Show all 21Show fewer
  • 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;
  • Known or suspected intolerance or hypersensitivity to the investigational medicinal product or any of its excipients; or known intolerance or hypersensitivity to drugs with the same target (e.g., FGF21 analogs, GLP-1 receptor agonists, GCGR agonists, etc.);
  • Subjects who have participated in clinical trials of other drugs and used investigational medicinal product within 12 weeks or 5 half-lives (whichever is longer) prior to screening, or those who have participated in medical device or vaccine clinical trials;
  • Alcohol consumption for at least 12 consecutive weeks within 1 year prior to screening, defined as any of the following: > 210 grams of ethanol per week for males on average, > 140 grams per week for females on average;
  • History of drug abuse or use of illicit drugs within 3 years prior to screening;
  • Pregnant or breastfeeding females, or females with a positive serum pregnancy test prior to randomization;
  • Subjects who, in the investigator's opinion, are otherwise not suitable for participation in this clinical trial.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

China3 sites

  • The First Hospital of Jilin University

    Changchun

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang

  • Nanjing Gulou Hospital

    Nanjing

Other trials in China

Hong Kong1 site

  • Prince of Wales Hospital, The Chinese University of Hong Kong

    Hong Kong, Hong Kong

Other trials in Hong Kong

About this study

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

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
Being tested
DR10624 Injection, Placebo
Keywords
NASH, MASH, NAFLD, MAFLD
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DR10624 InjectionDrug

    Drug: DR10624 injection

  • PlaceboDrug

    Drug: Placebo

Study groups in NCT07024212
Study groupRoleWhat they receive
Cohort 1：DR10624 injection/Placebo (SC, qw)ExperimentalDR10624 injection/Placebo (SC, qw)
Receives: Drug: DR10624 Injection; Drug: Placebo
Cohort 2：DR10624 injection/Placebo (SC, qw)ExperimentalDR10624 injection/Placebo (SC, qw)
Receives: Drug: DR10624 Injection; Drug: Placebo
Cohort 3：DR10624 injection/Placebo (SC, qw)ExperimentalDR10624 injection/Placebo (SC, qw)
Receives: Drug: DR10624 Injection; Drug: Placebo
Cohort 4：DR10624 injection/Placebo (SC, qw)ExperimentalDR10624 injection/Placebo (SC, qw)
Receives: Drug: DR10624 Injection; Drug: Placebo
Cohort 5：DR10624 injection/Placebo (SC, qw)ExperimentalDR10624 injection/Placebo (SC, qw)
Receives: Drug: DR10624 Injection; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of LFC

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

    Measured: From baseline to Week 12

Secondary outcomes (18)

  1. Changes of Controlled Attenuation Parameter (CAP)

    Changes of CAP from baseline to Week 12, assessed by FibroScan® VCTE.

    Measured: From baseline to Week 12

  2. Changes of Liver Stiffness Measurement (LSM)

    Changes of LSM from baseline assessed by FibroScan® VCTE.

    Measured: From baseline to Week 12

  3. Changes of LFC

    Changes of LFC from baseline to Week 12, assessed by MRI-PDFF.

    Measured: From baseline to Week 12

  4. Proportion of subjects achieving a relative reduction of LFC

    Proportion of subjects who achieve a relative reduction of LFC by ≥30%, ≥50%, or ≥70% from baseline to Week 12.

    Measured: From baseline to Week 12

  5. Proportion of subjects with LFC <5%

    Proportion of subjects with LFC <5% after 12 weeks of treatment.

    Measured: From baseline to Week 12

  6. Changes of liver enzymes

    Changes of liver enzymes from baseline to Week 16.

    Measured: From baseline to Week 16

  7. Proportion of subjects with ≥17 U/L reduction of ALT

    Proportion of subjects with ≥17 U/L reduction of ALT from baseline to Week 16.

    Measured: From baseline to week 16

  8. Changes of glucose metabolism-related parameters

    Changes of glucose metabolism-related parameters from baseline to Week 12.

    Measured: From baseline to Week 12

  9. Changes of lipid profiles

    Changes of lipid profiles from baseline to Week 16.

    Measured: From baseline to Week 16

  10. Changes of body weight

    Changes of body weight from baseline to Week 16

    Measured: From baseline to Week 16

  11. Changes of BMI

    Changes of BMI from baseline to Week 16, BMI = weight (kg)/height2 (m2), height is measured only at screening, while weight is measured at each corresponding visit.

    Measured: From baseline to Week 16

  12. Changes of hip circumference

    Changes of hip circumference from baseline to Week 16. The hip circumference should be recorded in cm, accurate to mm (e.g., 96.6 cm).

    Measured: From baseline to Week 16

  13. Changes of waist-to-hip ratio

    Changes of waist-to-hip ratio from baseline to Week 16 Waist-to-hip ratio = waist circumference (cm) / hip circumference (cm).

    Measured: From baseline to Week 16

  14. Changes of fibrosis biomarkers

    Changes from baseline in fibrosis biomarkers.

    Measured: From Baseline to Week 12

  15. Changes of hepatic inflammation markers

    Changes of hepatic inflammation markers from baseline to Week 12

    Measured: From baseline to week 12

  16. Analysis of Safety Endpoints

    Safety parameters from baseline to Week 16

    Measured: From baseline to week 16

  17. Immunogenicity analysis

    Assess the immunogenicity from baseline to Week 16

    Measured: From baseline to Week 16

  18. Pharmacokinetics profiles of DR10624 Injection

    Measurement of DR10624 plasma concentration and calculation of C trough.

    Measured: From baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start22 Apr 2025
  3. Primary completion18 Jun 2026
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024212
Sponsor's protocol ID
DR10624-202
Status last verified
Jul 2026
First submitted
24 Apr 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DR10624 Injection in people with MASLD, run by Zhejiang Doer Biologics Co., Ltd. at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of LFC (time frame: From baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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