Weight loss with AKM Lab-01 probiotic versus placebo
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
Run by Moon (Guangzhou) Biotechnology Co., Ltd. · NCT07331974 · Data updated 2026-11-12
This study tests whether daily AKM Lab-01 can help people who are overweight or obese lose weight compared with a placebo over 3 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Moon (Guangzhou) Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 18, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07331974 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with BMI between 24.0 and 40.0 kg/m² who have not used metabolic medications in the past month and have been attempting lifestyle-based weight management.
✕Probably not a fit
Individuals outside the BMI range, with recent metabolic medication use, or those not adhering to study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled interventional trial in adults with overweight or obesity. Participants will receive either AKM Lab-01 or a matching placebo daily for three months, with baseline and end-of-study measurements including weight, blood lipids, glucose, and gut/metabolomic profiles. Researchers will analyze changes in body weight and metabolic markers to explore potential mechanisms linked to the probiotic. Stool samples will be used for metagenomic analysis, and blood and stool will be studied for metabolomics insights. The study aims to characterize safety and potential weight-loss efficacy of AKM Lab-01 and understand how it may influence metabolic pathways.
Why it matters
Potential benefit: If successful, participants could experience weight loss and improvements in metabolic markers related to obesity.
How similar studies have gone: Similar probiotic approaches in obesity have shown signals of weight change and metabolic effects in prior research, though results vary by strain.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 1\) A clear history of neurological or psychiatric disorders (including epilepsy and dementia). * 2\) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure. * 3\) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease. * 4\) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness. * 5\) Participants with a family history of genetically inherited metabolic disorders. * 6\) Participants currently taking hepatotropic medications. * 7\) Participants with a history of prior bariatric surgery. * 8\) Presence of poorly controlled or unstable acute/chronic diseases, including but not limited to: * Cardiovascular diseases: Unstable angina, myocardial infarction within the past 6 months, symptomatic congestive heart failure (NYHA Class Ⅱ or higher), severe arrhythmia, ect. * Uncontrolled active infectious diseases, malignancies, ect. * 9\) Participants with hepatic or renal insufficiency, defined as: * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 2.5 × ULN (Upper Limit of Normal); * Serum total bilirubin \> 2.5 × ULN; * Creatinine (Cr) \> 1.5 × ULN. * 10\) Urine amylase ≥ 1.5 × ULN, or any other laboratory abnormality deemed by the investigator to be clinically significant and incompatible with study participation. * 11\) History of acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) within the past 3 months. * 12\) History of gastrointestinal surgery within the past year, or the presence of severe, active gastrointestinal disease that is not stabilized and may affect drug absorption, distribution, metabolism, or excretion. * 13\) Know hypersensitivity or allergy to any active ingredient or excipient of the investigational product. * 14\) Use of antibiotic therapy or intake of probiotics/prebiotic supplements within 3 month prior to screening. * 15\) Excessive alcohol consumption (defined as \> 30 grams per day for men or \> 20 gram, sraems) with the past 10 years. * 16\) pregnant or lactating women. * 17\) Any other medical condition that, in the judgement of the investigator, may put the participant at increased or be aggravated by participation in the study. The specific reason for exclusion based on this criterion must be documented.
Where it's running
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Guangzhou Huangpu District People's Hospital
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Baojia Huang
- Email: huangbj@moonbio.com
- Phone: 86-020-31603387
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.