Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-09 @ 6:30 AM
Study NCT ID:
NCT06579105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
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The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults ≥ 18 years of age.\n\nDiagnosed with T2DM for at least 6 months.\n\nHbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening.\n\nBody mass index of ≥ 23 kg/m2.\n\nStable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).\n\nExclusion Criteria:\n\nType 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.\n\nHistory of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.\n\nHave had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n\nReceived medication for weight loss within the last 3 months prior to screening.\n\nClinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.\n\nPrevious or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).\n\nHistory of acute or chronic pancreatitis.'}, 'identificationModule': {'nctId': 'NCT06579105', 'acronym': 'SOLSTICE', 'briefTitle': 'Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults With Type 2 Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'D7261C00001'}, 'secondaryIdInfos': [{'id': '2024-512562-34-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Participants will receive xx mg once daily dose of AZD5004', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Participants will receive xx mg once daily dose of AZD5004', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Participants will receive xx mg once daily dose of AZD5004', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Participants will receive xx mg once daily dose of AZD5004', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'Participants will receive xx mg once daily dose of AZD5004', 'interventionNames': ['Drug: AZD5004']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': 'Participants will receive xx mg once daily dose of AZD5004', 'interventionNames': ['Drug: AZD5004']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 7', 'description': 'Participants will receive once daily dose of Semaglutide as active comparator', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 8', 'description': 'Participants will receive matching placebo for each AZD5004 arm', 'interventionNames': ['Drug: Placebo (placebo matching AZD5004 film-coated tablet)']}], 'interventions': [{'name': 'Placebo (placebo matching AZD5004 film-coated tablet)', 'type': 'DRUG', 'description': 'Placebo film-coated tablet (matching AZD5004)', 'armGroupLabels': ['Arm 8']}, {'name': 'AZD5004', 'type': 'DRUG', 'description': 'AZD5004 film-coated tablet, once daily during 26 weeks', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6']}, {'name': 'Semaglutide', 'type': 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