Health TrialsbyHealthPanel

A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis

ConditionMetabolic Dysfunction-Associated Steatohepatitis (MASH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent

Participants must have histologic diagnosis of MASH by liver biopsy

Have liver fat content ≥8%

Participants must have a body mass index (BMI) ≥24 kilograms per square meter (kg/m²) and ≤40 kg/m² with stable body weight for at least 3 months

Disqualifiers

Model for End-Stage Liver Disease (MELD) score > 12, or Child-Pugh (CTP) score > 6

Known or suspected history of excessive alcohol consumption or alcohol dependence within 12 months prior to screening

History of liver cirrhosis and/or liver decompensation, including but not limited to ascites, hepatic encephalopathy, esophageal or gastric variceal bleeding, etc.

Previous or current liver disease due to other causes, including but not limited to: alcoholic steatohepatitis (ASH), drug-induced liver injury (DILI), viral hepatitis, autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hereditary hepatobiliary diseases (e.g., hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, etc.), occupational toxic liver disease, known or suspected hepatocellular carcinoma (HCC), etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4729 Injection

    Drug

    HRS-4729 Injection; high dose, low dose

  • HRS9531 Injection

    Drug

    HRS9531 Injection; high dose, low dose

  • HRS-4729 Injection Placebo

    Drug

    HRS-4729 Injection Placebo

  • HRS9531 Injection Placebo

    Drug

    HRS9531 Injection Placebo

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Treatment group A: HRS-4729 InjectionExperimental treatment 1 intervention
Group B: Treatment group B: HRS9531 InjectionExperimental treatment 1 intervention
Group C: Treatment group C: HRS-4729 Injection PlaceboPlacebo comparator 1 intervention
Group D: Treatment group D: HRS9531 Injection PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%).

Time frame
Baseline, Week 32

Secondary outcomes

1

Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

Time frame
Baseline, Week 52
2

Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology

Time frame
Baseline, Week 52
3

Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology

Time frame
Baseline, Week 52
4

Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology

Time frame
Baseline, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now