An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia

Prior treatment

• Currently taking liver-affecting medications.
• People with allergic constitution or hypersensitivity to the investigational product.
• Have used antibiotics, probiotics, or prebiotics within 3 months prior to recruitment.

Other illness

• Patients with secondary hyperlipidemia caused by conditions such as nephrotic syndrome, liver diseases, hypothyroidism, renal failure, etc..
• Have severe comorbidities requiring immediate treatment, including uncontrolled diabetes, hypertriglyceridemia, cerebrovascular diseases, etc., as determined by the investigator.
• Have severe primary diseases (e.g., hepatic, renal, or hematopoietic system disorders) or psychiatric conditions.
• Patients with a family history of genetically inherited metabolic disorders.
• Have a history of bariatric surgery.
• People with acute or chronic progressive/unstable diseases deemed unsuitable for enrollment by the investigator.
• Have a history of gastrointestinal surgery within the past year.

Lab values

• Have taken any metabolic control medications (e.g., lipid-lowering, blood glucose-regulating, or weight-loss drugs) within the past month or are currently taking such medications.
• Hepatic or renal dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5×upper limit of normal (ULN); Total bilirubin \>1.5×ULN; Serum creatinine (Cr) \>1.5×ULN.
• Serum amylase ≥1.5×ULN or other clinically significant laboratory abnormalities per investigator judgment.

Other

• Patients with acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) within the past 3 months.
• Excessive alcohol consumption in the past decade (\>30 g/day for males; \>20 g/day for females).
• Pregnant or breastfeeding subjects.
• Excluded for other reasons as determined by the investigator.

• Aged 35-75 years (inclusive), regardless of gender;
• Patients diagnosed with hypercholesterolemia (5.2 mmol/L ≤ TC \<6.2 mmol/L, or 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L), with or without hypertriglyceridemia (1.7 mmol/L ≤ TG \<4.5 mmol/L) or mixed hyperlipidemia (defined as: 1.7 mmol/L ≤ TG \<4.5 mmol/L and 5.2 mmol/L ≤ TC \<6.2 mmol/L; or 1.7 mmol/L ≤ TG \<4.5 mmol/L and 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L; or 1.7 mmol/L ≤ TG \<4.5 mmol/L, 5.2 mmol/L ≤ TC \<6.2 mmol/L and 3.4 mmol/L ≤ LDL-C \<5.0 mmol/L);
• Accompanied by overweight/obesity (24.0 ≤ BMI ≤40.0 kg/m²);
• Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;
• Have controlled of blood lipids solely through lifestyle interventions (diet and exercise) for at least 1 month prior to the screening period;
• People must possess communication and cognitive abilities to adhere to long-term medication, and fully understand the nature, significance, potential benefits, inconveniences, and risks of the study before participation;
• Fertile patients (male or female) must agree to use at least one medically approved contraceptive method (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during the trial. Female with childbearing potential must have a negative blood pregnancy test during screening and must not be lactating;
• Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule