AKM Lab-01 probiotic for high cholesterol in overweight adults

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia

This will see if taking a daily probiotic, AKM Lab-01, can lower cholesterol in adults aged 40–60 who are overweight and have high cholesterol.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years to 60 Years
• Sex: All
• Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Zibo, Shandong)
• Trial ID: NCT06974266 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial gave eligible participants daily oral doses of either the probiotic AKM Lab-01 or a matching placebo. Participants were adults 40–60 years old with mild to moderate hypercholesterolemia and BMI between 24.0 and 40.0 kg/m² who were not taking lipid or metabolic medications and had been managing lipids with lifestyle measures. Baseline and end-of-treatment clinical measures, blood samples, and stool specimens were collected to compare lipid levels and related biological markers. The design focuses on safety and whether the probiotic produces measurable changes compared with placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40–60 with mild to moderate hypercholesterolemia (specified TC/LDL-C ranges), BMI 24–40 kg/m², and who have been controlling lipids by diet and exercise without lipid or metabolic drugs for at least one month.

Not a fit: People currently taking statins or other lipid/metabolic medications, those with severe/uncontrolled hypercholesterolemia or outside the age/BMI ranges, or those unable to attend study visits are unlikely to benefit from or qualify for this protocol.

Why it matters

Potential benefit: If successful, AKM Lab-01 could offer a safe, daily probiotic option to help lower cholesterol and improve metabolic markers for overweight adults with mild to moderate hypercholesterolemia.

How similar studies have performed: Early human and animal research on Akkermansia muciniphila has shown promise for weight and glucose-related outcomes, but evidence specifically for cholesterol lowering is limited and this application remains relatively novel.

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.

Where this trial is running

Zibo, Shandong

• PKUCare Luzhong Hospital — Zibo, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Baojia Huang

Conditions Hypercholesterolaemia