Metabolic Dysfunction-associated Steatohepatitis (MASH)Phase 2NCT07620366
To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis
A Phase 2 study testing QL2401 25 mg, QL2401 50 mg and QL2401 100 mg in people with Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatohepatitis (MASH)
- What is being tested?
- QL2401 25 mg, QL2401 50 mg and QL2401 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Mar 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18 - 80 years of age inclusive, based on the date of signation of ICF.
- Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.
- Any one criterion as follow:
- Liver biopsy proved MASH (NAS ≥ 4 with steatosis, ballooning degeneration and lobular inflammation ≥ 1) with fibrosis stage 2 to 3 at screening or within 6 months; or
- VCTE measured liver stiffness 8.0 kPa ≤ LSM < 20.0 kPa, CAP>302 dB/m.
- Hepatic fat fraction > 10% measured by MRI-PDFF at screening.
- Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.
- Participants maintain a stable body weight (±5%) within 2 months prior screening.
Who cannot join
- Currently or prior history of hepatocellular carcinoma.
- Previous or planned liver transplant.
- History or evidence of any acute or chronic liver disease other than MASH.
- Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH) and Liver Fibrosis
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).
- Being tested
- QL2401 25 mg, QL2401 50 mg, QL2401 100 mg, QL2401 placebo 25 mg, QL2401 placebo 50 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2401 25 mgDrug
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks.
QL2401 50 mgDrug
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks.
QL2401 100 mgDrug
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks.
QL2401 placebo 25 mgDrug
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
QL2401 placebo 50 mgDrug
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
QL2401 placebo 100 mgDrug
Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| QL2401 25 mg | Experimental | Not described Receives: Drug: QL2401 25 mg |
| QL2401 50 mg | Experimental | Not described Receives: Drug: QL2401 50 mg |
| QL2401 100 mg | Experimental | Not described Receives: Drug: QL2401 100 mg |
| QL2401 placebo 25 mg | Placebo comparator | Not described Receives: Drug: QL2401 placebo 25 mg |
| QL2401 placebo 50 mg | Placebo comparator | Not described Receives: Drug: QL2401 placebo 50 mg |
| QL2401 placebo 100 mg | Placebo comparator | Not described Receives: Drug: QL2401 placebo 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 12 relative to baseline
Change from baseline in hepatic fat fraction, measured by MRI-PDFF
Measured: 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.
- First posted2 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Steatohepatitis (MASH)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620366
- Sponsor's protocol ID
- QL2401-201
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH) and Liver Fibrosis
- ClinicalTrials.gov ID
- NCT07620366
- Acronym / sponsor ID
- QL2401-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| QL2401 25 mg | Experimental | Drug: QL2401 25 mg |
| QL2401 50 mg | Experimental | Drug: QL2401 50 mg |
| QL2401 100 mg | Experimental | Drug: QL2401 100 mg |
| QL2401 placebo 25 mg | Placebo comparator | Drug: QL2401 placebo 25 mg |
| QL2401 placebo 50 mg | Placebo comparator | Drug: QL2401 placebo 50 mg |
| QL2401 placebo 100 mg | Placebo comparator | Drug: QL2401 placebo 100 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females between 18 - 80 years of age inclusive, based on the date of signation of ICF.
- Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.
- Any one criterion as follow:
- Hepatic fat fraction > 10% measured by MRI-PDFF at screening.
- Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.
Key exclusion criteria (5 listed)
- Currently or prior history of hepatocellular carcinoma.
- Previous or planned liver transplant.
- History or evidence of any acute or chronic liver disease other than MASH.
- Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).
- Other inclusion and exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL2401 25 mgQL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks. | Drug | QL2401 25 mg |
| QL2401 50 mgQL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks. | Drug | QL2401 50 mg |
| QL2401 100 mgQL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks. | Drug | QL2401 100 mg |
| QL2401 placebo 25 mgMatching placebo administered via subcutaneous injection, once-weekly for 48 weeks. | Drug | QL2401 placebo 25 mg |
| QL2401 placebo 50 mgMatching placebo administered via subcutaneous injection, once-weekly for 48 weeks. | Drug | QL2401 placebo 50 mg |
| QL2401 placebo 100 mgMatching placebo administered via subcutaneous injection, once-weekly for 48 weeks. | Drug | QL2401 placebo 100 mg |
Primary outcome
Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 12 relative to baseline
Time frame: Baseline to Week 12
Change from baseline in hepatic fat fraction, measured by MRI-PDFF
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL2401 25 mg, QL2401 50 mg and QL2401 100 mg in people with Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Qilu Pharmaceutical Co., Ltd..
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 5 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Dandan Guo, Master (+86-0531-55821372, dandan1.guo@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in liver fat content (%) measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at week 12 relative to baseline (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2026.