An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia

Official title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia

Overview

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.

Interventions

• Dietary supplement Probiotic
  Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.
• Dietary supplement Placebo
  Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.

Primary outcome measures

• Changes in TC and LDL-C [Time frame: Baseline, Day30，Day90]
• AE and SAE [Time frame: Up to 4months]

Secondary outcome measures (8)

• Changes in Blood Lipids [Time frame: Baseline, Day30, Day90]
• Changes in FBG [Time frame: Baseline, Day30, Day90]
• Changes in Blood Pressure [Time frame: Baseline, Day30, Day90]
• Changes in Uric Acid [Time frame: Baseline, Day30, Day90]
• Changes in Weight [Time frame: Baseline, Day30, Day90]
• Changes in HbA1c [Time frame: Baseline, Day30, Day90]
• Changes in Waist Circumference and Hip Circumference [Time frame: Baseline, Day30, Day90]
• Changes in Body Fat Percentage [Time frame: Baseline, Day30, Day90]

Eligibility criteria

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;
• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• PKUCare Luzhong Hospital — Zibo

Identifiers

NCT: NCT06974266 · MN-AKM-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗