Metabolic Dysfunction-associated Steatohepatitis (MASH)Phase 2NCT06937749
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Phase 2 study testing IBI362 in people with Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-associated Steatohepatitis (MASH)
- What is being tested?
- IBI362
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 22 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be willing to participate in the study and provide written informed consent.
- Male or female, age 18 years or older at the time of signing informed consent
- Body mass Index (BMI) ≥25 kg/m²
- Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening
Who cannot join
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- HbA1c>10%
- History or current other forms of chronic liver disease other than MASH
- Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening
- patients with HCV antibody positive.
- Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)
- Model for End-stage Liver Disease(MELD) >12 or Child-Turcotte-Pugh(CTP) >6
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.
- Being tested
- Placebo, IBI362
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo administered subcutaneously (SC) once a week.
IBI362Drug
IBI362 administered subcutaneously (SC) once a week.
| Study group | Role | What they receive |
|---|---|---|
| IBI362 Low Dose | Experimental | Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for 52 weeks Receives: Drug: IBI362 |
| IBI362 High Dose | Experimental | Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for for 4 weeks; Dose level 4,SC,once a week for 48 weeks Receives: Drug: IBI362 |
| Placebo | Placebo comparator | Placebo,SC,once a week for 60 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Measured: Baseline, Week 60
Secondary outcomes (26)
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Measured: Baseline, Week 60
Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology
Measured: Baseline, Week 60
Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Measured: Baseline, Week 60
Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Measured: Baseline, Week 60
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Measured: Baseline, Week 60
Mean Absolute Change and Percentage Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Measured: Baseline, Week 4, Week 12, Week 36, Week 60
Percentage of participants with at least 30%, 50% and 70% relative reduction in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) From Baseline
Measured: Baseline, Week 4, Week 12, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]
Measured: Baseline, Week 36, Week 60
Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction
Measured: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in BMI [kg/m2]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Waist Circumference [cm]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L
Measured: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]
Measured: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]
Measured: Baseline, Week 36, Week 60
Change from Baseline in Homeostasis Model Assessment IR
Measured: Baseline, Week 36, Week 60
Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)
The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)
Measured: Baseline, Week 36, Week 60
Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)
NASH-CHECK scores range from 0 to 10, with higher scores indicating worse symptoms/HRQOL
Measured: Baseline, Week 36, Week 60
Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）
6-point Patient Global Impression of Severity of NASH symptoms (PGIS; 7-day recall period; responses ranging from "no symptoms" to "very severe").
Measured: Baseline, Week 36, Week 60
The proportion of subjects with at least a 25% improvement in liver stiffness measurement (LSM) relative to baseline based on FibroScan and FibroTouch measurements, and the proportion of subjects with at least a 30% improvement in controlled attenuation
Measured: Baseline, Week 36, Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 Jun 2025
- Primary completion23 Sep 2026
- Study completion22 Jul 2027 (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 Innovent Biologics (Suzhou) 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937749
- Sponsor's protocol ID
- CIBI362C201
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT06937749
- Acronym / sponsor ID
- CIBI362C201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 22 Apr 2025 (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 multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI362 Low Dose | Experimental | Drug: IBI362Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for 52 weeks |
| IBI362 High Dose | Experimental | Drug: IBI362Dose level 1,SC,once a week for 4 weeks; Dose level 2,SC,once a week for 4 weeks; Dose level 3,SC,once a week for for 4 weeks; Dose level 4,SC,once a week for 48 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo,SC,once a week for 60 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be willing to participate in the study and provide written informed consent.
- Male or female, age 18 years or older at the time of signing informed consent
- Body mass Index (BMI) ≥25 kg/m²
- Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening
Key exclusion criteria (7 listed)
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- HbA1c>10%
- History or current other forms of chronic liver disease other than MASH
- Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening
- patients with HCV antibody positive.
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 |
|---|---|---|
| PlaceboPlacebo administered subcutaneously (SC) once a week. | Drug | Placebo |
| IBI362IBI362 administered subcutaneously (SC) once a week. | Drug | IBI362 High Dose, IBI362 Low Dose |
Primary outcome
Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Time frame: Baseline, Week 60
26 secondary outcomes
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame: Baseline, Week 60
Percentage of Participants With MASH improvement With no Worsening of Fibrosis on Liver Histology
Time frame: Baseline, Week 60
Percentage of Participants With MASH improvement With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame: Baseline, Week 60
Percentage of Participants With MASH resolution With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame: Baseline, Week 60
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage on Liver Histology
Time frame: Baseline, Week 60
Mean Absolute Change and Percentage Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline, Week 4, Week 12, Week 36, Week 60
Percentage of participants with at least 30%, 50% and 70% relative reduction in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) From Baseline
Time frame: Baseline, Week 4, Week 12, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in aspartate aminotransferase[U/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in alanine aminotransferase[U/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in a γ-Glutamyl transferase[U/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]
Time frame: Baseline, Week 36, Week 60
Percentage of Participants who Achieve ≥5%, ≥10% and ≥15% Body Weight Reduction
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in BMI [kg/m2]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Waist Circumference [cm]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Plasma Glucose (FPG )[mmol/L
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in Fasting Blood Insulin[mlU/L]
Time frame: Baseline, Week 36, Week 60
Mean Absolute Change from Baseline in glycated hemoglobin A1c (HbA1c)[%]
Time frame: Baseline, Week 36, Week 60
Change from Baseline in Homeostasis Model Assessment IR
Time frame: Baseline, Week 36, Week 60
Changes from baseline in scores in 36-item Short-Form Health Survey version 2(SF-36v2)
Time frame: Baseline, Week 36, Week 60
Change from baseline in scores in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)
Time frame: Baseline, Week 36, Week 60
Change from baseline in scores in PGI-SPatient Global Impression of Severity（PGI-S）
Time frame: Baseline, Week 36, Week 60
The proportion of subjects with at least a 25% improvement in liver stiffness measurement (LSM) relative to baseline based on FibroScan and FibroTouch measurements, and the proportion of subjects with at least a 30% improvement in controlled attenuation
Time frame: Baseline, Week 36, Week 60
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 20 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI362 in people with Metabolic Dysfunction-associated Steatohepatitis (MASH), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology (time frame: Baseline, Week 60). 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 20 Oct 2026.