An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia (NCT06974266) | Clinical Trial Compass
RecruitingNot Applicable
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
China60 participantsStarted 2025-06-25
Plain-language 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 trial, eligible hypercholesterolemic participants were administered daily oral doses of either AKM Lab-01 or a placebo. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.
Who can participate
Age range40 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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
. 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.