Comparing IBI362 and Semaglutide for treating overweight adults with fatty liver disease

A Multicenter, Randomized, Open-label Phase III Study to Compare the Efficacy and Safety of IBI362 and Semaglutide in Chinese Overweight or Obese Subjects With Metabolic Dysfunction-associated Fatty Liver Disease (GLORY-3)

This study is testing whether a new drug called IBI362 can help overweight adults with fatty liver disease just as well as the existing treatment Semaglutide.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06884293 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical study is a multicenter, randomized, open-label trial that evaluates the efficacy and safety of IBI362 compared to Semaglutide in overweight or obese adults diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD). Participants will be randomly assigned to receive either IBI362 9 mg or Semaglutide 2.4 mg, both administered subcutaneously once a week. The study includes a 4-week screening period, a 48-week treatment phase, and a 12-week follow-up for safety assessment after drug withdrawal.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI of 27 kg/m2 or higher and diagnosed with MAFLD.

Not a fit: Patients with a history of type 1 diabetes or those who have used weight loss medications recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for overweight or obese adults suffering from MAFLD.

How similar studies have performed: Other studies have shown success with similar GLP-1 receptor agonist approaches, indicating potential for positive outcomes in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female, age 18 years or older at the time of signing informed consent
2. diagnosed as MAFLD according to the Chinese Guideline for the prevention and treatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (Version 2024)
3. liver fat content ≥8% measured by MRI-PDFF
4. BMI≥27 kg/m2
5. Weight change ≤5% within 3 months before screening
6. HbA1c≤10%

Exclusion Criteria:

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
2. Used drugs or alternative therapies with weight loss effects within 3 months before screening, including but not limited to: GLP-1 receptor agonists, orlistat, phenylpropanolamine, chlorpheniramine, phentermine etc.
3. Received chronic (\>2 weeks) systemic glucocorticoid treatment within 3 months before screening (excluding topical, intraocular, intranasal, and inhaled administration)
4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)
5. Active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period

Where this trial is running

Beijing, Beijing

• Beijing Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Lixin Guo, M.D — Beijing Hospital
• Study coordinator: lixin guo

Conditions Overweight; Metabolic Dysfunction-associated Fatty Liver Disease