Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 5:36 AM
Study NCT ID:
NCT07160400
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with adverse events (AEs)', 'timeFrame': 'Part A: Baseline up to Day 15', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.'}, {'measure': 'Number of Participants with adverse events (AEs)', 'timeFrame': 'Part B: Baseline up to Day 43', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.'}, {'measure': 'Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug', 'timeFrame': 'Part A: Baseline up to Day 15', 'description': 'A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.'}, {'measure': 'Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug', 'timeFrame': 'Part B: Baseline up to Day 43', 'description': 'A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.'}, {'measure': 'Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug', 'timeFrame': 'Part A: Baseline up to Day 15', 'description': 'A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.'}, {'measure': 'Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug', 'timeFrame': 'Part B: Baseline up to Day 43', 'description': 'A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Under the Serum Concentration-time Curve (AUC) of IBI3032', 'timeFrame': 'Part A: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.'}, {'measure': 'Under the Serum Concentration-time Curve (AUC) of IBI3032', 'timeFrame': 'Part B: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.'}, {'measure': 'maximum concentration (Cmax) of IBI3032', 'timeFrame': 'Part A: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.'}, {'measure': 'maximum concentration (Cmax) of IBI3032', 'timeFrame': 'Part B: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.'}, {'measure': 'time to maximum concentration (Tmax) of IBI3032', 'timeFrame': 'Part A: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.'}, {'measure': 'time to maximum concentration (Tmax) of IBI3032', 'timeFrame': 'Part B: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.'}, {'measure': 'clearance (CL) of IBI3032', 'timeFrame': 'Part A: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.'}, {'measure': 'clearance (CL) of IBI3032', 'timeFrame': 'Part B: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.'}, {'measure': 'apparent volume of distribution (V) of IBI3032', 'timeFrame': 'Part A: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.'}, {'measure': 'apparent volume of distribution (V) of IBI3032', 'timeFrame': 'Part B: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.'}, {'measure': 'elimination half-life (T1/2) of IBI3032', 'timeFrame': 'Part A: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.'}, {'measure': 'elimination half-life (T1/2) of IBI3032', 'timeFrame': 'Part B: Predose up to 168 hours postdose', 'description': 'To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Part A: Healthy Part B: Overweight or Obesity']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single ascending dose of IBI3032 in healthy participants and multiple ascending doses of IBI3032 in participants with overweight or obesity. It consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy participants, and Part B is a multiple ascending dose (MAD) study in participants with overweight or obesity during the 4-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 18-65 years (inclusive) at the time of informed consent.\n2. Participants must understand the procedures and methods of this study, be willing to complete the study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. The investigator suspects that the participant may be allergic to any component of the study drug or GLP-1 receptor agonists, or have used GLP-1 receptor agonists within 3 months prior to screening.\n2. History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose \\< 3.9 mmol/L or ≥ 7.0 mmol/Lat screening.\n3. Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.'}, 'identificationModule': {'nctId': 'NCT07160400', 'briefTitle': 'A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics Technology Limited (Shanghai R&D Center)'}, 'officialTitle': 'A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032 After a Single Ascending Dose in Healthy Participants and After Multiple Ascending Doses in Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'CIBI3032A101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose of IBI3032 administered orally.', 'description': 'Part A', 'interventionNames': ['Drug: IBI3032 tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single dose of placebo administered orally.', 'description': 'Part A', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple doses of IBI3032 administered orally.', 'description': 'Part B', 'interventionNames': ['Drug: IBI3032 tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Multiple doses of placebo administered orally.', 'description': 'Part B', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose placebo IBI3032 administered orally', 'armGroupLabels': ['Multiple doses of placebo administered orally.', 'Single dose of placebo administered orally.']}, {'name': 'IBI3032 tablets', 'type': 'DRUG', 'description': 'Single dose of IBI3032 administered orally', 'armGroupLabels': ['Multiple doses of IBI3032 administered orally.', 'Single dose of IBI3032 administered orally.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuening Li', 'role': 'CONTACT', 'email': 'li.xuening@zs-hospital.sh.cn', 'phone': '021-31587862'}], 'facility': 'Zhongshan Hospital affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Dee Li', 'role': 'CONTACT', 'email': 'dee.li@innoventbio.com', 'phone': '18017984650'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics Technology Limited (Shanghai R&D Center)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}