Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT06579092
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in body weight from baseline', 'timeFrame': '26 weeks', 'description': 'To determine whether AZD5004 is superior to placebo for weight loss'}, {'measure': 'Achieved Weight Loss ≥ 5% From Baseline', 'timeFrame': '26 weeks', 'description': 'To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline'}], 'secondaryOutcomes': [{'measure': 'Percent change in body weight from baseline', 'timeFrame': '36 weeks', 'description': 'To determine whether AZD5004 is superior to placebo for weight loss'}, {'measure': 'Achieved weight loss ≥ 5% from baseline', 'timeFrame': '36 weeks', 'description': 'To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline'}, {'measure': 'Absolute change from baseline in body weight', 'timeFrame': 'Week 26 and Week 36', 'description': 'To determine whether AZD5004 is superior to placebo for absolute weight loss'}, {'measure': 'Achieved weight loss ≥ 10% as well as ≥ 15% from baseline', 'timeFrame': 'Week 26 and Week 36', 'description': 'To assess the effect of AZD5004 versus placebo on achieving weight loss ≥ 10% as well as ≥ 15% from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity or Overweight']}, 'descriptionModule': {'briefSummary': 'A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \\[BMI\\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity', 'detailedDescription': 'This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):\n\n (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea\n* A stable body weight for 3 months prior to Screening (± 5% body weight change).\n\nExclusion Criteria:\n\n* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.\n* Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.\n* Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).\n* History of type 1 diabetes mellitus or type 2 diabetes mellitus.\n* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.\n* History of acute or chronic pancreatitis."}, 'identificationModule': {'nctId': 'NCT06579092', 'acronym': 'VISTA', 'briefTitle': 'Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity', 'orgStudyIdInfo': {'id': 'D7260C00001'}, 'secondaryIdInfos': [{'id': '2024-513691-18-00', 'type': 'REGISTRY', 'domain': 'EU CT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Active IMP', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Active IMP', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Active IMP', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Active IMP', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'Active IMP', 'interventionNames': ['Drug: AZD5004']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 6', 'description': 'Matching placebo for each of the 5 active arms', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD5004', 'type': 'DRUG', 'otherNames': ['Active IMP'], 'description': 'AZD5004 film-coated tablet once daily during 36 weeks', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching AZD5004 film-coated tablet once daily during 36 weeks', 'armGroupLabels': ['Arm 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 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Centre Leicester Diabetes Centre - Bloom University of Leicester'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. 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All requests will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.\n\nSigned Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}