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NCT07620366Not yet recruitingPhase 2

To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
132 (estimated)
First submitted
27 May 2026
Start date
1 Dec 2026
Primary completion date
30 Jun 2027
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
NCT number
NCT07620366

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 132
  • From 1 Dec 2026 to the primary completion date, 30 Jun 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently or prior history of hepatocellular carcinoma.
  • Previous or planned liver transplant.
  • Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).
    • Other inclusion and exclusion criteria may apply.

Other illness

  • History or evidence of any acute or chronic liver disease other than MASH.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.