NCT07331974

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight , Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-31
• Completion: 2027-05-31
• First posted: 2026-01-12
• Last updated: 2026-01-15

Locations

1 site across 1 country: China