RecruitingNot ApplicableNCT07331974

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.

Enrollment

200 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AKM Lab-01 and a drug called Placebo for people with overweight/obesity. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAKM Lab-01

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

DRUGPlacebo

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


Locations(1)

Guangzhou Huangpu District People's Hospital

Guangzhou, Guangdong, China

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NCT07331974


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