An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
NCT ID: NCT06974266
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-06-25
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic
Subjects receive AKM Lab-01 Enteric-coated Capsule
Probiotic
Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.
Placebo
Subjects receive placebo
Placebo
Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.
Interventions
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Probiotic
Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.
Placebo
Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
60 Years
ALL
No
Sponsors
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Moon (Guangzhou) Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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PKUCare Luzhong Hospital
Zibo, Shandong, China
Countries
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Central Contacts
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Other Identifiers
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MN-AKM-101
Identifier Type: -
Identifier Source: org_study_id