Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-25 @ 4:19 PM
Study NCT ID:
NCT06635057
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR'}, {'measure': 'Number of Hypoglycemic Events', 'timeFrame': 'Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR'}, {'measure': 'Number of Self-Reported Gastrointestinal (GI) Adverse Events', 'timeFrame': 'Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR'}, {'measure': 'Percentage of Participants Achieving HbA1c <7%', 'timeFrame': 'Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR'}, {'measure': 'Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L)', 'timeFrame': 'SoR (Week 0), EoR (Week 4)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ramadan', 'Fasting'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to investigate whether tirzepatide can be effectively started before Ramadan and used per label in participants with Type 2 Diabetes during the fasting month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a clinical diagnosis of uncontrolled Type 2 Diabetes based on the World Health Organization classification or other locally applicable diagnostic standards, and who intend to fast during Ramadan\n* Have HbA1c ≥7% within 30 days prior to screening\n* Are glucagon-like peptide-1 receptor agonist (GLP-1 RA) naïve\n* Have had stable body weight self-reported change ≤5 kilograms (kg) during the 90 days prior to screening\n* Have body mass index ≥25 kilograms per square meter (kg/m2) at screening\n\nExclusion Criteria:\n\n* Have Type 1 Diabetes or gestational diabetes\n* Have a history of chronic or acute pancreatitis\n* Have acute or chronic hepatitis\n* Have evidence of a significant, uncontrolled endocrine abnormality\n* Have a history of an active or untreated malignancy\n* Have New York Heart Association Functional Classification IV congestive heart failure\n* Have been treated with insulin within two weeks prior to screening'}, 'identificationModule': {'nctId': 'NCT06635057', 'acronym': 'T-RAM', 'briefTitle': 'A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 4, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Effectiveness and Safety of Tirzepatide Once Weekly in Adult Participants With Type 2 Diabetes During Ramadan', 'orgStudyIdInfo': {'id': '27195'}, 'secondaryIdInfos': [{'id': 'I8F-MC-GPIY', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tirzepatide', 'description': 'Participants will receive tirzepatide subcutaneously (SC)', 'interventionNames': ['Drug: Tirzepatide']}], 'interventions': [{'name': 'Tirzepatide', 'type': 'DRUG', 'otherNames': ['LY3298176'], 'description': 'Administered SC', 'armGroupLabels': ['Tirzepatide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36342', 'city': 'Al Ahasa', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966135369999'}, {'name': 'Ibrahim Kadhim Al Kadhim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al Moosa Specialist Hospital'}, {'zip': '36428', 'city': 'Alahsa', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966135910000'}, {'name': 'Maram Alsubaie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Guard Hospital-King Abdulaziz Medical City'}, {'zip': '21423', 'city': 'Jeddah', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966126860897'}, {'name': 'Reem Alamoudy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Abdulaziz Medical City-Jeddah', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '21433', 'city': 'Jeddah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966505402105'}, {'name': 'Samia Bokhari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Fahad Armed Forces Hospital Jeddah', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '21499', 'city': 'Jeddah', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '96614647729'}, {'name': 'Areej Alkhairy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Faisal Specialist Hospital & Research Center', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'city': 'Jeddah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966503561850'}, {'name': 'Moahemd Daghestani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saudi Airlines Medical services', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'zip': '42523', 'city': 'Madinah', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966920012312'}, {'name': 'Fahad Wali', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Faisal Specialist Hospital and Research Center Madina', 'geoPoint': {'lat': 24.46861, 'lon': 39.61417}}, {'zip': '11472', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '96614670878'}, {'name': 'Mohammed Al Sofiani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Saud University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '11525', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966536448950'}, {'name': 'Mohammed Al Mehthel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Osepdale Fatebenefratelli e Oftalmico', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '11652', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '96614702777'}, {'name': 'Metib Alotaibi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al Dallah Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12214', 'city': 'Riyadh', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '96655285222'}, {'name': 'Said Khader', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sulaiman Habib Olaya', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '12311', 'city': 'Riyadh', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966502469148'}, {'name': 'Nader AlBalkhi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Specialized Medical Center Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '14963', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966118275555'}, {'name': 'Khaled Al Dossari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dallah Namar Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '14963', 'city': 'Riyadh', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966553335159'}, {'name': 'Khaled Al Dossari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr. Sulaiman Al Habib Hospital As Suwaidi', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Riyadh', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'role': 'CONTACT', 'phone': '966552233291'}, {'name': 'Ibrahim Alsadhan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr. Sulaiman Al Habib Medical Complex Arrayan Saudi Arabia', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '133500', 'city': 'Abu Dhabi', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97180055'}, {'name': 'Baiju Faizal Puthenkote', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lifecare Hospital', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'zip': '34761', 'city': 'Abu Dhabi', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97137677444'}, {'name': 'Asma Jabri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tawam Hospital', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97124040800'}, {'name': 'Nader Lessan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imperial College London Diabetes Center', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '971528916223'}, {'name': 'Dinesh Kumar Dhanwal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NMC Abu Dhabi', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Ajman', 'status': 'COMPLETED', 'country': 'United Arab Emirates', 'facility': 'Rashid Centre for Diabetes and Research', 'geoPoint': {'lat': 25.40177, 'lon': 55.47878}}, {'city': 'Ajman', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '971507879619'}, {'name': 'Mahir Khalil Ibrahim Jallo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thumbay University Hospital', 'geoPoint': {'lat': 25.40177, 'lon': 55.47878}}, {'zip': '0000', 'city': 'Dubai', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '971800444444'}, {'name': 'Jalal Nafach', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emirates Hospital Dubai', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Arab Emirates', 'facility': 'Aster Clinics', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97142193000'}, {'name': 'Jalal Nafach', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dubai Diabetes Center', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97142195000'}, {'name': 'Fatheya Al Awadi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dubai Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '9718006332273'}, {'name': 'Abduljabbar Haroon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medcare Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97144359999'}, {'name': 'Maryam Al Saeed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mediclinic City Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Dubai', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '97143371111'}, {'name': 'Khadija Hafidh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rashid Hospital.', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'zip': '0000', 'city': 'Sharjah city', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'phone': '9718006332273'}, {'name': 'Zeenat Naseeb', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medcare Hospital', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'centralContacts': [{'name': 'There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'ClinicalTrials.gov@lilly.com', 'phone': '1-317-615-4559'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}