Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-25 @ 4:45 PM
Study NCT ID:
NCT06972992
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2025-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'up to 71 days', 'description': 'Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'up to 71 days', 'description': 'Change from baseline (week 1) to week 10 in body weight was evaluated'}, {'measure': 'Cmax of ASC47', 'timeFrame': 'up to 71 days', 'description': 'Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide.'}, {'measure': 'AUC of ASC47', 'timeFrame': 'up to 71 days', 'description': 'Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide.'}, {'measure': 'T1/2 of ASC47', 'timeFrame': 'up to 71 days', 'description': 'Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide.'}, {'measure': 'CL/F of ASC47', 'timeFrame': 'up to 71 days', 'description': 'Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Weight Management']}, 'descriptionModule': {'briefSummary': 'This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject have provided informed consent before initiation of any study specific procedures\n* Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.\n* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).\n* Stable body weight (less than 5% self-reported change within the previous 3 months)\n\nExclusion Criteria:\n\n* Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.\n* Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n* Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.\n* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.\n* Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.'}, 'identificationModule': {'nctId': 'NCT06972992', 'briefTitle': 'A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascletis Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity', 'orgStudyIdInfo': {'id': 'ASC47-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combo Cohort 1 in participants with obesity', 'description': 'Cohort 1, dose 1', 'interventionNames': ['Drug: ASC47 +Semaglutide', 'Drug: Placebo+Semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Cohort 2 in participants with obesity', 'description': 'Cohort 2, dose 2', 'interventionNames': ['Drug: ASC47 +Semaglutide', 'Drug: Placebo+Semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Combo Cohort 3 in participants with obesity', 'description': 'Cohort 3, dose 3', 'interventionNames': ['Drug: ASC47 +Semaglutide', 'Drug: Placebo+Semaglutide']}], 'interventions': [{'name': 'ASC47 +Semaglutide', 'type': 'DRUG', 'description': 'ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks', 'armGroupLabels': ['Combo Cohort 1 in participants with obesity', 'Combo Cohort 2 in participants with obesity', 'Combo Cohort 3 in participants with obesity']}, {'name': 'Placebo+Semaglutide', 'type': 'DRUG', 'description': 'Placebo single subcutaneous injection + Semaglutide QW for 4 weeks', 'armGroupLabels': ['Combo Cohort 1 in participants with obesity', 'Combo Cohort 2 in participants with obesity', 'Combo Cohort 3 in participants with obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascletis Clinical Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascletis Pharma (China) Co., Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}