NCT07331974招募中不适用
A Randomized, Double-blind, Placebo-controlled Trial to Access the Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 in Participents With Overweigh and Obesity
Moon (Guangzhou) Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年7月1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
- 200
- 试验地点
- 1
- 主要终点
- Changes in BMI
研究概览
简要总结
This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Age: 18-60 years old (inclusive); Gender: male or female.
- •2) Body Mass Index (24.0≤BMI≤40.0 kg/m²).
- •3) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month.
- •4) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening.
- •5) Processes adequate communication and cognitive abilities, is expected to be compliant with long-term medication, and has understood the nature, significance, potential benefits, inconveniences, and risks of the study prior to enrollment.
- •6) For participants of childbearing potential (male or female): Must agree to use at least one medically approved form of contraception (e.g., intrauterine device [IUD], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative serum pregnancy test at screening and must be non-lactating.
- •7) Voluntarily agrees to participate by signing the inform consent form and commits to follow the trial treatment plan and visit schedule.
排除标准
- •1) A clear history of neurological or psychiatric disorders (including epilepsy and dementia).
- •2) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure.
- •3) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease.
- •4) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness.
- •5) Participants with a family history of genetically inherited metabolic disorders.
- •6) Participants currently taking hepatotropic medications.
- •7) Participants with a history of prior bariatric surgery.
- •8) Presence of poorly controlled or unstable acute/chronic diseases, including but not limited to:
- •Cardiovascular diseases: Unstable angina, myocardial infarction within the past 6 months, symptomatic congestive heart failure (NYHA Class Ⅱ or higher), severe arrhythmia, ect.
- •Uncontrolled active infectious diseases, malignancies, ect.
- •9) Participants with hepatic or renal insufficiency, defined as:
- •Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2.5 × ULN (Upper Limit of Normal);
- •Serum total bilirubin > 2.5 × ULN;
- •Creatinine (Cr) > 1.5 × ULN.
- •10) Urine amylase ≥ 1.5 × ULN, or any other laboratory abnormality deemed by the investigator to be clinically significant and incompatible with study participation.
- •11) History of acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) within the past 3 months.
- •12) History of gastrointestinal surgery within the past year, or the presence of severe, active gastrointestinal disease that is not stabilized and may affect drug absorption, distribution, metabolism, or excretion.
- •13) Know hypersensitivity or allergy to any active ingredient or excipient of the investigational product.
- •14) Use of antibiotic therapy or intake of probiotics/prebiotic supplements within 3 month prior to screening.
- •15) Excessive alcohol consumption (defined as > 30 grams per day for men or > 20 gram, sraems) with the past 10 years.
- •16) pregnant or lactating women.
- •17) Any other medical condition that, in the judgement of the investigator, may put the participant at increased or be aggravated by participation in the study. The specific reason for exclusion based on this criterion must be documented.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants receive placebo
干预措施: Placebo (Drug)
Probiotics
Experimental
Subjects receive investigational product AKM Lab-01
干预措施: AKM Lab-01 (Drug)
结局指标
主要结局
Changes in BMI
时间窗: Baseline, Day 30, Day 60, Day 90
Changes in BMI from baseline will be assessed
Changes in body weight
时间窗: Baseline, Day 30, Day 60, Day 90
Changes in body weight from baseline will be assessed.
次要结局
- Changes in HbA1c(Baseline, Day 30, Day 90)
- Changes in Uric Acid(Baseline, Day30, Day90)
- Changes in Blood Pressure(Baseline, Day 30, Day 60, Day 90)
- Changes in TC(Baseline, Day 90)
- Changes in LDL-C(Baseline, Day 90)
研究者
研究点 (1)
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