HypercholesterolaemiaAKM Lab-01NCT06974266
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
A study testing Probiotic in people with Hypercholesterolaemia, run by Moon (Guangzhou) Biotechnology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Hypercholesterolaemia
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.
PlaceboDietary supplement
Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Subjects receive AKM Lab-01 Enteric-coated Capsule Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Subjects receive placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in TC and LDL-C
The changes in serum TC and LDL-C of participants from baseline
Measured: Baseline, Day30，Day90
AE and SAE
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.
Measured: Up to 4months
Secondary outcomes (8)
Changes in Blood Lipids
Changes of participants from baseline in HDL-C and Triglyceride
Measured: Baseline, Day30, Day90
Changes in FBG
Changes of participants from baseline in Fasting blood glucose (FBG)
Measured: Baseline, Day30, Day90
Changes in Blood Pressure
Changes of participants from baseline in blood pressure
Measured: Baseline, Day30, Day90
Changes in Uric Acid
Changes of participants from baseline in Uric Acid
Measured: Baseline, Day30, Day90
Changes in Weight
Changes of participants from baseline in weight
Measured: Baseline, Day30, Day90
Changes in HbA1c
Changes of participants from baseline in HbA1c
Measured: Baseline, Day30, Day90
Changes in Waist Circumference and Hip Circumference
Changes of participants from baseline in waist circumference and hip circumference
Measured: Baseline, Day30, Day90
Changes in Body Fat Percentage
Changes of participants from baseline in body fat percentage
Measured: Baseline, Day30, Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start25 Jun 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974266
- Sponsor's protocol ID
- MN-AKM-101
- Acronym
- AKM Lab-01
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided