No phaseRecruiting
Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity
A Randomized, Double-blind, Placebo-controlled Trial to Access the Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 in Participents With Overweigh and Obesity
- Sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd. (Industry)
- Enrolment
- 200 planned
- Conditions
- Overweight , Obesity
- Interventions
- AKM Lab-01; Placebo
- Ages
- adults
- Registry
- NCT07331974
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Changes in BMI
- Changes in body weight
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered