No phaseActive, not recruiting

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

Sponsor
Moon (Guangzhou) Biotechnology Co., Ltd. (Industry)
Enrolment
60 planned
Conditions
Hypercholesterolaemia
Interventions
Probiotic; Placebo
Ages
adults, older adults
Registry
NCT06974266

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Changes in TC and LDL-C
  • AE and SAE

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered