Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:37 AM
Study NCT ID:
NCT07324850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SGB-7342 in Subjects With Obesity or Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'up to approximately 6 months'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'up to approximately 3 days'}, {'measure': 'Area Under the Concentration-time Curve (AUC)', 'timeFrame': 'up to 3 days'}, {'measure': 'Weight change from baseline', 'timeFrame': 'up to approximately 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of subcutaneously administered SGB-7342 in adult subjects with obesity and overweight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body Mass Index (BMI) within the range of 26.0 to 35.0 kg/m²\n* Have a stable body weight within 3 months\n* Participants must agree to use adequate contraception from signing the informed consent until 6 months after completion of the follow-up visit.\n* Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.\n\nExclusion Criteria:\n\n* A history of or a current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.\n* Use of GLP-1R agonists for any indication within 6 months prior to administering the investigational drug.\n* Use of non-GLP1R medications for weight loss within 3 months prior to administering the investigational drug.\n* Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST)\\> 1.5 × ULN, and deemed clinically significant by the Investigators"}, 'identificationModule': {'nctId': 'NCT07324850', 'briefTitle': 'A Study of SGB-7342 in Subjects With Obesity or Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Sanegene Bio Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-7342 in Subjects With Obesity or Overweight', 'orgStudyIdInfo': {'id': 'SGB-7342-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGB-7342', 'interventionNames': ['Drug: SGB-7342']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SGB-7342-Matching placebo', 'interventionNames': ['Drug: SGB-7342-Matching placebo']}], 'interventions': [{'name': 'SGB-7342', 'type': 'DRUG', 'description': 'SC injection, single dose', 'armGroupLabels': ['SGB-7342']}, {'name': 'SGB-7342-Matching placebo', 'type': 'DRUG', 'description': 'Normal saline (0.9% NaCl) in a matching volume, SC injection, single dose', 'armGroupLabels': ['SGB-7342-Matching placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SGB.clinical', 'role': 'CONTACT', 'email': 'SGB.clinical@sanegenebio.com', 'phone': '+086 021-60209828'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Sanegene Bio Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}