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NOT YET RECRUITING
NCT07331974
NA

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

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-02-01

Completion Date

2027-05-31

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

AKM Lab-01

A specific dose of AKM Lab-01 will be administered orally once daily for a period of 3 months.

DRUG

Placebo

Placebo will be administered orally once daily for a period of 3 months.

Locations (1)

Guangzhou Huangpu District People Hospital

Guangzhou, Guangdong, China