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

Study acronym: AKM Lab-01
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 30, 2026 → Oct 30, 2026
See other at-risk trials from Moon (Guangzhou) Biotechnology Co., Ltd.

Record History

  1. Enrollment closed, study ongoing Primary completion pushed from Jul 30, 2026 to Oct 30, 2026 · Eligibility criteria expanded, about 25 words · Site details revised Show 3 more changesShow less
    • Primary completion pushed from Jul 30, 2026 to Oct 30, 2026
    • Eligibility criteria expanded, about 25 words
    • Site details revised
  2. Eligibility criteria revisedv3 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 10, 2025 to Jun 25, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 10, 2025 to Jun 25, 2025
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06974266
Lead Sponsor Moon (Guangzhou) Biotechnology Co., Ltd.
Conditions Hypercholesterolaemia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov