Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT06974266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in TC and LDL-C', 'timeFrame': 'Baseline, Day30，Day90', 'description': 'The changes in serum TC and LDL-C of participants from baseline'}, {'measure': 'AE and SAE', 'timeFrame': 'Up to 4months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in Blood Lipids', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in HDL-C and Triglyceride'}, {'measure': 'Changes in FBG', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in Fasting blood glucose (FBG)'}, {'measure': 'Changes in Blood Pressure', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in blood pressure'}, {'measure': 'Changes in Uric Acid', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in Uric Acid'}, {'measure': 'Changes in Weight', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in weight'}, {'measure': 'Changes in HbA1c', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in HbA1c'}, {'measure': 'Changes in Waist Circumference and Hip Circumference', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in waist circumference and hip circumference'}, {'measure': 'Changes in Body Fat Percentage', 'timeFrame': 'Baseline, Day30, Day90', 'description': 'Changes of participants from baseline in body fat percentage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolaemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 40-60 years (inclusive), regardless of gender;\n2. 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);\n3. Accompanied by overweight/obesity (24.0 ≤ BMI ≤40.0 kg/m²);\n4. Have not taken any metabolic control medications (for lipid, weight, or blood glucose) within the past month;\n5. Have controlled of blood lipids solely through lifestyle interventions (diet and exercise) for at least 1 month prior to the screening period;\n6. 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;\n7. 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;\n8. Voluntary enrollment with signed informed consent, and commitment to comply with the trial treatment regimen and visit schedule\n\nExclusion Criteria:\n\n1. 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.\n2. Patients with secondary hyperlipidemia caused by conditions such as nephrotic syndrome, liver diseases, hypothyroidism, renal failure, etc..\n3. Have severe comorbidities requiring immediate treatment, including uncontrolled diabetes, hypertriglyceridemia, cerebrovascular diseases, etc., as determined by the investigator.\n4. Have severe primary diseases (e.g., hepatic, renal, or hematopoietic system disorders) or psychiatric conditions.\n5. Patients with a family history of genetically inherited metabolic disorders.\n6. Currently taking liver-affecting medications.\n7. Have a history of bariatric surgery.\n8. People with acute or chronic progressive/unstable diseases deemed unsuitable for enrollment by the investigator.\n9. 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.\n10. Serum amylase ≥1.5×ULN or other clinically significant laboratory abnormalities per investigator judgment.\n11. Patients with acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) within the past 3 months.\n12. Have a history of gastrointestinal surgery within the past year.\n13. People with allergic constitution or hypersensitivity to the investigational product.\n14. Have used antibiotics, probiotics, or prebiotics within 3 months prior to recruitment.\n15. Excessive alcohol consumption in the past decade (\\>30 g/day for males; \\>20 g/day for females).\n16. Pregnant or breastfeeding subjects.\n17. Excluded for other reasons as determined by the investigator.'}, 'identificationModule': {'nctId': 'NCT06974266', 'acronym': 'AKM Lab-01', 'briefTitle': 'An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Moon (Guangzhou) Biotechnology Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Preliminary Efficacy of Akkermansia Muciniphila AKM Lab-01 in Subjects With Hypercholesterlemia', 'orgStudyIdInfo': {'id': 'MN-AKM-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Subjects receive AKM Lab-01 Enteric-coated Capsule', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects receive placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects receive AKM Lab-01 Enteric-coated once daily by oral, 34B TFU/day , within half an hour after breakfast for 3 months.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects receive placebo once daily by oral, one capsule/day, within half an hour after breakfast for 3 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Baojia Huang', 'role': 'CONTACT', 'email': 'huangbj@moonbio.com', 'phone': '+86-020-31603387'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moon (Guangzhou) Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}