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 range
35 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 35-75 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 criteria
. 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.