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
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.
• 1\) Age: 18-60 years old (inclusive); Gender: male or female.
• 2\) Body Mass Index (24.0≤BMI≤40.0 kg/m²).
• 3\) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month.
• 4\) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening.
• 5\) Processes adequate communication and cognitive abilities, is expected to be compliant with long-term medication, and has understood the nature, significance, potential benefits, inconveniences, and risks of the study prior to enrollment.
• 6\) For participants of childbearing potential (male or female): Must agree to use at least one medically approved form of contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative serum pregnancy test at screening and must be non-lactating.
• 7\) Voluntarily agrees to participate by signing the inform consent form and commits to follow the trial treatment plan and visit schedule.