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Tests treatment safety and results for Hypercholesterolaemia
Official title An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
ClinicalTrials.gov ID: NCT06974266
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- 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...
- 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;
You likely can't join if
- Have taken any metabolic control medications (e.g., lipid-lowering, blood glucose-regulating, or weight-loss drugs) within the past month or are...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule
What rules you out
- 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 people.
- Excluded for other reasons as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zibo, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zibo, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.