An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia

NCT06974266 | Recruiting

• 1 other identifier: MN-AKM-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. Baseline clinical parameters, blood samples, and stool specimens were collected before and after the intervention for comparative analysis.

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (2)

• Changes in TC and LDL-C

  The changes in serum TC and LDL-C of participants from baseline

  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.

  Up to 4months

Secondary Outcomes (8)

• Changes in Blood Lipids

  Baseline, Day30, Day90

• Changes in FBG

  Baseline, Day30, Day90

• Changes in Blood Pressure

  Baseline, Day30, Day90

• Changes in Uric Acid

  Baseline, Day30, Day90

• Changes in Weight

  Baseline, Day30, Day90

Study Arms (2)

Probiotic

EXPERIMENTAL

Subjects receive AKM Lab-01 Enteric-coated Capsule

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Subjects receive placebo

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.

Placebo

Probiotic DIETARY_SUPPLEMENT

Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.

Probiotic

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 40-60 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Moon (Guangzhou) Biotechnology Co., Ltd.: lead

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Baojia Huang

CONTACT

+86-020-31603387; huangbj@moonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 15, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)