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Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jan 31, 2027 → Mar 31, 2027
See other at-risk trials from Moon (Guangzhou) Biotechnology Co., Ltd.

Record History

  1. Primary completion pushed from Jan 31, 2027 to Mar 31, 2027 Completion pushed from May 31, 2027 to Jun 30, 2027 · Start date changed from estimate of Jul 1, 2026 to Jun 18, 2026 · Eligibility criteria expanded, about 29 words · 1 more Show 4 more changesShow less
    • Completion pushed from May 31, 2027 to Jun 30, 2027
    • Start date changed from estimate of Jul 1, 2026 to Jun 18, 2026
    • Eligibility criteria expanded, about 29 words
    • Site details revised
  2. Recruitment opened Start date: Feb 1, 2026 to Jul 1, 2026 · Study site revisedv3 Show 2 more changesShow less
    • Start date: Feb 1, 2026 to Jul 1, 2026
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Secondary endpoints: 4 to 5v2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.
Trial Details
NCT Number NCT07331974
Lead Sponsor Moon (Guangzhou) Biotechnology Co., Ltd.
Conditions Overweight , Obesity
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov