NCT06974266

An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.

Conditions

• Hypercholesterolaemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.
DIETARY_SUPPLEMENT	Placebo	Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-07-30
• Completion: 2026-12-30
• First posted: 2025-05-15
• Last updated: 2025-12-30

Locations

1 site across 1 country: China