Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT04686994
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2020-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment 3:1 ratio'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Up to 28 days', 'description': 'Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days'}], 'secondaryOutcomes': [{'measure': 'AUC of ASC41', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.'}, {'measure': 'Cmax of ASC41', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.'}, {'measure': 't1/2 of ASC41', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.'}, {'measure': 'CL/F of ASC41', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.'}, {'measure': 'Vd/F of ASC41', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.'}, {'measure': 'Tmax of ASC41', 'timeFrame': 'Up to 28 days', 'description': 'Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.'}, {'measure': 'LDL-C and other lipid parameters', 'timeFrame': 'Up to 28 days', 'description': 'To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight and Obesity', 'NAFLD', 'Hyperlipidemia', 'LDL-C', 'NASH'], 'conditions': ['Overweight and Obesity', 'NAFLD', 'Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 23kg/m2 ≤ BMI \\<40kg/m2.\n\nKey Exclusion Criteria:\n\n* A history of thyroid disease.\n* A positive HBsAg, HCV Ab and/or HIV Ab.'}, 'identificationModule': {'nctId': 'NCT04686994', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': 'ASC41-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASC41', 'description': 'ASC41 two tablets, once daily, from Day 1 to Day 28.', 'interventionNames': ['Drug: ASC 41']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ASC41 placebo', 'description': 'ASC41 placebo two tablets, once daily, from Day 1 to Day 28.', 'interventionNames': ['Drug: ASC 41 Placebo']}], 'interventions': [{'name': 'ASC 41', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['ASC41']}, {'name': 'ASC 41 Placebo', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['ASC41 placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': "Hunan provincial people's hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gannex Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Hunan Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}