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ACTIVE NOT RECRUITING
NCT06974266
NA

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

Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-25

Completion Date

2026-12-30

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China