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

Launched by MOON (GUANGZHOU) BIOTECHNOLOGY CO., LTD. · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called AKM Lab-01 to see if it can help people with high cholesterol, a condition known as hypercholesterolemia. The participants will be adults aged 40 to 60 who have been diagnosed with this condition and are either overweight or obese. They need to have been managing their cholesterol through diet and exercise for at least a month before joining the study. Participants will be randomly assigned to receive either AKM Lab-01 or a placebo (a harmless pill with no active ingredient) for a certain period of time.

During the trial, participants will provide blood and stool samples to help researchers understand how well the treatment works and if it is safe. To join, individuals should not have taken any medications for cholesterol or weight control in the past month and must be able to follow the study guidelines. It's important for interested individuals to discuss this opportunity with their healthcare provider to see if they meet the criteria and understand the commitment involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 40-60 years (inclusive), regardless of gender;
• • 2. 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);
• • 3. Accompanied by overweight/obesity (24.0 ≤ BMI ≤40.0 kg/m²);
• • 4. Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;
• • 5. Have controlled of blood lipids solely through lifestyle interventions (diet and exercise) for at least 1 month prior to the screening period;
• • 6. 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;
• • 7. 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;
• • 8. Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule
• Exclusion Criteria:
• • 1. 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.
• • 2. Patients with secondary hyperlipidemia caused by conditions such as nephrotic syndrome, liver diseases, hypothyroidism, renal failure, etc..
• • 3. Have severe comorbidities requiring immediate treatment, including uncontrolled diabetes, hypertriglyceridemia, cerebrovascular diseases, etc., as determined by the investigator.
• • 4. Have severe primary diseases (e.g., hepatic, renal, or hematopoietic system disorders) or psychiatric conditions.
• • 5. Patients with a family history of genetically inherited metabolic disorders.
• • 6. Currently taking liver-affecting medications.
• • 7. Have a history of bariatric surgery.
• • 8. People with acute or chronic progressive/unstable diseases deemed unsuitable for enrollment by the investigator.
• • 9. 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.
• • 10. Serum amylase ≥1.5×ULN or other clinically significant laboratory abnormalities per investigator judgment.
• • 11. Patients with acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) within the past 3 months.
• • 12. Have a history of gastrointestinal surgery within the past year.
• • 13. People with allergic constitution or hypersensitivity to the investigational product.
• • 14. Have used antibiotics, probiotics, or prebiotics within 3 months prior to recruitment.
• • 15. Excessive alcohol consumption in the past decade (\>30 g/day for males; \>20 g/day for females).
• • 16. Pregnant or breastfeeding subjects.
• • 17. Excluded for other reasons as determined by the investigator.