Study to Evaluate the Safety and Weight-Loss Effects of Akkermansia Muciniphila AKM Lab-01 in Adults Who Are Overweight or Obese

What this Trial Is About

Researchers are evaluating the weight-loss effects and safety of AKM Lab-01 in adults who are overweight or obese. This randomized, double-blind, placebo-controlled study aims to understand how AKM Lab-01 influences body weight, blood lipids, blood glucose, and gut bacteria profiles in this population. The study is conducted by Moon Guangzhou Biotechnology Co., Ltd. and focuses on treatment over a period of three months. Participants will be randomly assigned to receive either the investigational product AKM Lab-01 or a matching placebo. Both treatments are taken orally once daily for three months. Before and after the intervention, researchers will collect baseline metrics and samples of blood, urine, and stool to analyze changes in body weight, body mass index, blood lipids, blood glucose, and gut microbiome. Additional metabolomic analysis of these samples will explore how AKM Lab-01 may affect body weight. Throughout the study, participants will be monitored at multiple time points including baseline, day 30, day 60, and day 90 for changes in weight and body mass index. Blood pressure and blood test markers such as total cholesterol, LDL cholesterol, HbA1c, and uric acid will also be assessed. Participants are expected to comply with the treatment and visit schedule, with researchers tracking safety and treatment effects during the three-month trial period. The total study duration extends until May 2027.

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