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.
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.
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.
Parallel
AKM Lab-01
DrugA specific dose of AKM Lab-01 will be administered orally once daily for a period of 3 months.
Placebo
DrugPlacebo will be administered orally once daily for a period of 3 months.
Changes in BMI
Changes in BMI from baseline will be assessed
Changes in body weight
Changes in body weight from baseline will be assessed.
Changes in TC
Changes in serum TC from baseline will be assessed.
Changes in HbA1c
Changes in HbA1c from baseline will be assessed.
Changes in Uric Acid
Changes in Uric Acid from baseline will be assessed.
Changes in Blood Pressure
Changes of systolic and diastolic blood pressure from baseline will be assessed.
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