Status:
RECRUITING
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
Lead Sponsor:
Moon (Guangzhou) Biotechnology Co., Ltd.
Conditions:
Hypercholesterolaemia
Eligibility:
All Genders
40-60 years
Phase:
NA
Brief Summary
The purpose of this study was to assess the safety and efficacy of AKM Lab-01 in subjects with hypercholesterolemia. This study will be conducted as a randomized, double-blind, placebo-controlled tria...
Eligibility Criteria
Inclusion
- Aged 40-60 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
Exclusion
- 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.
- 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.
- Currently taking liver-affecting medications.
- Have a history of bariatric surgery.
- People with acute or chronic progressive/unstable diseases deemed unsuitable for enrollment by the investigator.
- 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.
- Patients with acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) within the past 3 months.
- Have a history of gastrointestinal surgery within the past year.
- People with allergic constitution or hypersensitivity to the investigational product.
- Have used antibiotics, probiotics, or prebiotics within 3 months prior to recruitment.
- 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.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06974266
Start Date
June 25 2025
End Date
December 30 2026
Last Update
December 30 2025
Active Locations (1)
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1
PKUCare Luzhong Hospital
Zibo, Shandong, China