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New treatment option for Metabolic Dysfunction-associated Steatohepatitis (MASH)
Official title A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT06937749
What this study is testing
What is IBI362?
IBI362 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis (mash).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- people 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)
See the full eligibility criteria
- 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...
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.