Pasteurized Akkermansia muciniphila therapy for fatty liver in MASLD

Development of Microbial Therapeutics for Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Investigations to Clinical Trials

This test gives pasteurized Akkermansia muciniphila to adults with MASLD to see if it reduces liver fat.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Leeuwenhoek Laboratories Co. Ltd. (industry)
• Locations: 1 site (Taipei)
• Trial ID: NCT07488975 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial gives adults with MASLD oral doses of inactivated (pasteurized) Akkermansia muciniphila LWHK0003 at low, medium, or high doses or placebo. The trial emphasizes safety and looks for changes in liver fat using FibroScan CAP and other metabolic markers. Key exclusions include recent use of antibiotics, probiotics, GLP-1 receptor agonists, or drugs that affect fat metabolism, as well as pregnancy or breastfeeding. The approach builds on preclinical and early human work linking gut microbiota modulation to metabolic liver disease and will provide initial clinical safety and efficacy signals.

Who should consider this trial

Good fit: Adults with MASLD who have hepatic steatosis shown by FibroScan CAP ≥260 dB/m and who have not recently used excluded medications or probiotics are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, have recent antibiotic or probiotic use, recent GLP-1 RA use, or are taking drugs that affect fat metabolism may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, this therapy could lower liver fat and improve metabolic measures using a non-live, microbiome-derived treatment.

How similar studies have performed: Small animal studies and early human trials of pasteurized Akkermansia muciniphila have shown metabolic benefits, but clinical evidence specifically in MASLD is limited.

Eligibility criteria

Inclusion Criteria:

* Fibroscan，CAP ≧ 260db/m

Exclusion Criteria:

A. Pregnant women or women who are breastfeeding. B. Use of probiotics and prebiotic-related products (including yogurt, yogurt, Yakult, etc.) within 14 days before the screening visit.

C. Patients who have used antibiotics (except skin lotions) or antifungal drugs within 30 days before the screening visit.

D. Use of glucagon-like peptide-1 receptor agonists (GLP1-RAs) within six months prior to the screening visit.

E. Use of drugs that may affect the evaluation index within 14 days before the screening visit, during the screening visit, or during the planned trial period, such as steroids, immunosuppressants, or anti-inflammatory drugs, or drugs containing ingredients for treating hepatitis or affecting fat metabolism, including HMG-CoA reductase inhibitors (statins), fibrates, silymarin, thiazolidinediones, metformin, cholestyramine, ezetimibe, orlistat, and sodium-glucose transporter type 2 inhibitors (SGLT2i). This restriction does not apply if the above-mentioned drugs have been used continuously for more than six months and the dosage is not changed during the trial.

F. Those who have had severe gastrointestinal infection diarrhea symptoms within 14 days before the screening visit (more than three watery stools in 24 hours).

G. Have the following medical history or laboratory abnormalities:

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD, MASH