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

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.