Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT07291232
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 145 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.'}, {'measure': 'Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements', 'timeFrame': 'Up to approximately 145 days', 'description': 'Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.'}, {'measure': 'Number of Participants with Change from Baseline in Electrocardiogram (ECG)', 'timeFrame': 'Up to approximately 145 days', 'description': '12-lead resting ECG will be recorded.'}, {'measure': 'Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed', 'timeFrame': 'Up to approximately 145 days', 'description': 'Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'Cmax of ABBV-295'}, {'measure': 'Time to Cmax (Tmax) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'Tmax of ABBV-295'}, {'measure': 'Trough plasma concentration (Ctrough) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'Ctrough of ABBV-295'}, {'measure': 'Apparent terminal phase elimination rate constant (BETA) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'BETA of ABBV-295'}, {'measure': 'Terminal phase elimination half-life (t1/2) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 't1/2 of ABBV-295'}, {'measure': 'Area under the plasma concentration-time curve (AUC) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'AUC of ABBV-295'}, {'measure': 'Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'AUCtau of ABBV-295'}, {'measure': 'Dose Normalized Cmax of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'Dose normalized Cmax of ABBV-295 will be assessed.'}, {'measure': 'Dose Normalized AUC of ABBV-295', 'timeFrame': 'Up to approximately 145 days', 'description': 'Dose normalized AUC of ABBV-295 will be assessed.'}, {'measure': 'Incidence of Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Up to approximately 145 days', 'description': 'Incidence of ADAs will be assessed.'}, {'measure': 'Percent Change in Body Weight From Baseline', 'timeFrame': 'Up to approximately 145 days', 'description': 'Percent change in body weight (kg) will be assessed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'ABBV-295'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M26-089', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 30.0 to ≤ 45.0 kg/m2 after rounding to the tenths decimal at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).\n* A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.\n* HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.\n* Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 180 days prior to study treatment administration.'}, 'identificationModule': {'nctId': 'NCT07291232', 'briefTitle': 'A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Subcutaneous Doses of ABBV-295 in Adult Subjects With Obesity', 'orgStudyIdInfo': {'id': 'M26-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-295 or Placebo-Group 1', 'description': 'Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.', 'interventionNames': ['Drug: ABBV-295', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-295 or Placebo-Group 2', 'description': 'Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.', 'interventionNames': ['Drug: ABBV-295', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-295 or Placebo-Group 3', 'description': 'Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.', 'interventionNames': ['Drug: ABBV-295', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-295 or Placebo-Group 4', 'description': 'Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.', 'interventionNames': ['Drug: ABBV-295', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-295 or Placebo-Group 5-Optional', 'description': 'Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.', 'interventionNames': ['Drug: ABBV-295', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-295 or Placebo-Group 6', 'description': 'Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.', 'interventionNames': ['Drug: ABBV-295', 'Drug: Placebo']}], 'interventions': [{'name': 'ABBV-295', 'type': 'DRUG', 'description': 'Subcutaneous Injections', 'armGroupLabels': ['ABBV-295 or Placebo-Group 1', 'ABBV-295 or Placebo-Group 2', 'ABBV-295 or Placebo-Group 3', 'ABBV-295 or Placebo-Group 4', 'ABBV-295 or Placebo-Group 5-Optional', 'ABBV-295 or Placebo-Group 6']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous Injections', 'armGroupLabels': ['ABBV-295 or Placebo-Group 1', 'ABBV-295 or Placebo-Group 2', 'ABBV-295 or Placebo-Group 3', 'ABBV-295 or Placebo-Group 4', 'ABBV-295 or Placebo-Group 5-Optional', 'ABBV-295 or Placebo-Group 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Acpru /Id# 278624', 'geoPoint': {'lat': 42.34447, 'lon': -88.04175}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}