Metabolic Dysfunction-Associated Steatohepatitis (MASH)Phase 2NCT07660848
A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis
A Phase 2 study testing HRS-4729 Injection and HRS9531 Injection in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- What is being tested?
- HRS-4729 Injection and HRS9531 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 14 Aug 2026to Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period
- Use of GLP-1 receptor agonists (including multi-target drugs or compound preparations containing GLP-1 receptor agonists) within 3 months prior to screening, or previous discontinuation of GLP-1 receptor agonists due to safety/tolerance reasons
- Known or suspected hypersensitivity to GLP-1 and/or GIP and/or GCG receptor agonists and/or their excipient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Lai Wei, +86-010-68322662, Weelai@163.com
Lai Wei
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zujiang Yu, +86-0371-6691694, johnyuem@zzu.edu.cn
Zujiang Yu
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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.
- Being tested
- HRS-4729 Injection, HRS9531 Injection, HRS-4729 Injection Placebo, HRS9531 Injection Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4729 InjectionDrug
HRS-4729 Injection; high dose, low dose
HRS9531 InjectionDrug
HRS9531 Injection; high dose, low dose
HRS-4729 Injection PlaceboDrug
HRS-4729 Injection Placebo
HRS9531 Injection PlaceboDrug
HRS9531 Injection Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-4729 Injection | Experimental | Not described Receives: Drug: HRS-4729 Injection |
| Treatment group B: HRS9531 Injection | Experimental | Not described Receives: Drug: HRS9531 Injection |
| Treatment group C: HRS-4729 Injection Placebo | Placebo comparator | Not described Receives: Drug: HRS-4729 Injection Placebo |
| Treatment group D: HRS9531 Injection Placebo | Placebo comparator | Not described Receives: Drug: HRS9531 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: Baseline, Week 32
Secondary outcomes (5)
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Measured: Baseline, Week 52
Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology
Measured: Baseline, Week 52
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Measured: Baseline, Week 52
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology
Measured: Baseline, Week 52
Treatment-Emergent Adverse Events (TEAEs)
Measured: Baseline, Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start14 Aug 2026
- Primary completionMar 2028 (estimated)
- Study completionJul 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 Fujian Shengdi 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660848
- Sponsor's protocol ID
- HRS-4729-201
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT07660848
- Acronym / sponsor ID
- HRS-4729-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-4729 Injection | Experimental | Drug: HRS-4729 Injection |
| Treatment group B: HRS9531 Injection | Experimental | Drug: HRS9531 Injection |
| Treatment group C: HRS-4729 Injection Placebo | Placebo comparator | Drug: HRS-4729 Injection Placebo |
| Treatment group D: HRS9531 Injection Placebo | Placebo comparator | Drug: HRS9531 Injection Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
- History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period
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 |
|---|---|---|
| HRS-4729 InjectionHRS-4729 Injection; high dose, low dose | Drug | Treatment group A: HRS-4729 Injection |
| HRS9531 InjectionHRS9531 Injection; high dose, low dose | Drug | Treatment group B: HRS9531 Injection |
| HRS-4729 Injection PlaceboHRS-4729 Injection Placebo | Drug | Treatment group C: HRS-4729 Injection Placebo |
| HRS9531 Injection PlaceboHRS9531 Injection Placebo | Drug | Treatment group D: HRS9531 Injection Placebo |
Primary outcome
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline, Week 32
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 (%).
5 secondary outcomes
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline, Week 52
Percentage of Participants With Absence of MASH With no Worsening of Fibrosis on Liver Histology
Time frame: Baseline, Week 52
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame: Baseline, Week 52
Percentage of Participants With ≥ 1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame: Baseline, Week 52
Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline, Week 56
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-4729 Injection and HRS9531 Injection in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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 Mengshan Ni (+86-0518-81220121, mengshan.ni.mn1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) (time frame: Baseline, Week 32). 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 26 Aug 2026.