Actively Recruiting
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
Led by Moon (Guangzhou) Biotechnology Co., Ltd. · Updated on 2025-12-30
60
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 40-60 years, any gender
- Diagnosed with hypercholesterolemia within specified cholesterol and lipid ranges
- Overweight or obese with BMI between 24.0 and 40.0 kg/m²
- No metabolic control medications taken in the past month
- Blood lipids controlled by diet and exercise alone for at least 1 month before screening
- Able to understand and comply with study requirements
- Fertile participants agree to use approved contraception; females must have a negative pregnancy test and not be breastfeeding
- Voluntarily consent and agree to follow study procedures and visits
You will not qualify if you...
- Taking metabolic control medications currently or within past month
- Secondary hyperlipidemia from other medical conditions
- Severe diseases needing immediate treatment or severe primary diseases or psychiatric conditions
- Family history of inherited metabolic disorders
- Taking medications affecting the liver
- History of bariatric surgery
- Acute or unstable diseases unsuitable for study
- Significant liver or kidney dysfunction based on lab tests
- Elevated serum amylase or other lab abnormalities
- Recent acute diabetic complications
- History of gastrointestinal surgery within past year
- Allergies or hypersensitivity to the study product
- Use of antibiotics, probiotics, or prebiotics within 3 months
- Excessive alcohol use in past 10 years
- Pregnant or breastfeeding
- Other investigator-determined exclusions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
PKUCare Luzhong Hospital
Zibo, Shandong, China
Actively Recruiting
Research Team
B
Baojia Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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