NCT06974266招募中不适用
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia
Moon (Guangzhou) Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月25日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in TC and LDL-C
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects receive placebo
干预措施: Placebo (Dietary Supplement)
Probiotic
Experimental
Subjects receive AKM Lab-01 Enteric-coated Capsule
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Changes in TC and LDL-C
时间窗: Baseline, Day30，Day90
The changes in serum TC and LDL-C of participants from baseline
AE and SAE
时间窗: Up to 4months
During the trial, all subjects are observed and recorded for any adverse events (AEs) that occur during the study period, the incidence, type and severity of serious adverse events (SAEs), including clinical symptoms and abnormalities in vital signs, and abnormalities in lab tests, with determination of the correlation between them and the investigational drug.
次要结局
- Changes in Blood Pressure(Baseline, Day30, Day90)
- Changes in Blood Lipids(Baseline, Day30, Day90)
- Changes in Uric Acid(Baseline, Day30, Day90)
- Changes in Weight(Baseline, Day30, Day90)
- Changes in Waist Circumference and Hip Circumference(Baseline, Day30, Day90)
- Changes in Body Fat Percentage(Baseline, Day30, Day90)
- Changes in FBG(Baseline, Day30, Day90)
- Changes in HbA1c(Baseline, Day30, Day90)
研究者
研究点 (1)
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