Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-28 @ 6:40 AM
Study NCT ID:
NCT06679959
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of AEs, SAEs (Safety and tolerability) of ASC30', 'timeFrame': 'Up to Day169', 'description': 'A summary of AEs, SAEs and other non-serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Cmax of ASC30', 'timeFrame': 'Up to Day169', 'description': 'PK parameters of ASC30'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Up to Day169', 'description': 'Change From Baseline in Body Weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Weight Management']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have provided informed consent before initiation of any study-specific procedures.\n2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).\n3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.\n\nExclusion Criteria:\n\n1. Have evidence of any clinically significant active or chronic disease.\n2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.\n3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.\n4. Have a history of acute or chronic pancreatitis.\n5. Participants with a known clinically significant gastric emptying abnormality.\n6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.\n7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.'}, 'identificationModule': {'nctId': 'NCT06679959', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'A Phase I/IIa, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection, for Subcutaneous Use in Participants With Obesity', 'orgStudyIdInfo': {'id': 'ASC30-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 1', 'description': 'SAD Dose 1', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 2', 'description': 'SAD Dose 2', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 3', 'description': 'SAD Dose 3', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 4', 'description': 'SAD Dose 4', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 5', 'description': 'SAD Dose 5', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 6', 'description': 'SAD Dose 6', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 7', 'description': 'SAD Dose 7', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAD Cohort 8', 'description': 'SAD Dose 8', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Cohort 1', 'description': 'MAD Dose 1', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Cohort 2', 'description': 'MAD Dose 2', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MAD Cohort 3', 'description': 'MAD Dose 3', 'interventionNames': ['Drug: ASC30 Injection, for subcutaneous use or placebo']}], 'interventions': [{'name': 'ASC30 Injection, for subcutaneous use or placebo', 'type': 'DRUG', 'description': 'Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use', 'armGroupLabels': ['MAD Cohort 1', 'MAD Cohort 2', 'MAD Cohort 3', 'SAD Cohort 1', 'SAD Cohort 2', 'SAD Cohort 3', 'SAD Cohort 4', 'SAD Cohort 5', 'SAD Cohort 6', 'SAD Cohort 7', 'SAD Cohort 8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascletis clinical site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascletis Pharma (China) Co., Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}