Development of Microbial Therapeutics for Metabolic-associated Fatty Liver Disease: From Mechanistic Investigations to Clinical Trials

The goal of this clinical trial is to investigate the efficacy and safety of pasteurized Akkermansia muciniphila strain NTUH\_Amuc03 (pAKK NTUH\_Amuc03) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Patients. The main question it aims to answer is: Does pAKK NTUH\_Amuc03 trend to reduce the body weight, improve abnormal blood lipids , NASLD activity score, and HOMA-IR ? Researchers will compare pAKK NTUH\_Amuc03 to a placebo (a look-alike substance that contains no Akk) to see if pAKK NTUH\_Amuc03 works to MASLD. Participants will: 1. Take capsule with pAKK NTUH\_Amuc03 or a placebo every day for 3 months 2. Visit the clinic once every 4 weeks for checkups and tests

NCT Number	NCT06873165
Lead Sponsor	National Taiwan University Hospital
Conditions	Metabolic Dysfunction-Associated Steatotic Liver Disease
Enrollment	40 participants
Start Date	2025-01-22
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-12