Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPV | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron | Experimental | Administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1C (HbA1c) | Baseline, up to 8 Weeks after Start of Ramadan |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol)) | Baseline, Up to 8 Weeks after Start of Ramadan | |
| Change From Baseline in Fasting Serum Glucose (FSG) | Baseline, Up to 8 Weeks after Start of Ramadan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarojini Naidu Medical College | Agra | 282003 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent Change from Baseline in Body Weight | Baseline, Up to 8 Weeks after Start of Ramadan |
| Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index | Baseline, Up to 8 Weeks after Start of Ramadan |
| Percent Change in HbA1c | 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan] |
| Percent Change in Body Weight | 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan] |
| Osmania General Hospital | Hyderabad | 500012 | India |
|
| Brij Medical Centre Pvt. Ltd. | Kanpur | 208020 | India |
|
| Apollo Multispeciality Hospitals limited | Kolkata | 700054 | India |
|
| KGN Diabetes and Endocrinology Centre | Mumbai | 400008 | India |
|
| Mysore Medical College and Research Institute | Mysore | 570001 | India |
|
| Supe Heart & Diabetes Hospital & Research Centre | Nashik | 422002 | India |
|
| Diabetes Clinic | Nellore | 524001 | India |
|
| Visakha Institute of Medical Sciences | Visakhapatna | 530040 | India |
|
| King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs | Al-Ahsa | 31982 | Saudi Arabia |
|
| King Fahad Specialist Hospital | Dammam | 32253 | Saudi Arabia |
|
| National Guard Health Affairs: King Abdulaziz Medical City | Jeddah | 21423 | Saudi Arabia |
|
| Dr. Soliman Fakeeh Hospital | Jeddah | 21461 | Saudi Arabia |
|
| King Abdulaziz University Hospital | Jeddah | 22254 | Saudi Arabia |
|
| King Fahad Armed Forces Hospital Jeddah | Jeddah | 23311 | Saudi Arabia |
|
| King Saud University Medical City | Riyadh | 11472 | Saudi Arabia |
|
| Dr. Soliman Fakeeh Hospital | Riyadh | 11564 | Saudi Arabia |
|
| Osepdale Fatebenefratelli e Oftalmico | Riyadh | 12231 | Saudi Arabia |
|
| JOSHA Research | Bloemfontein | 9301 | South Africa |
|
| TREAD Research | Cape Town | 7500 | South Africa |
|
| TASK Central | Cape Town | 7530 | South Africa |
|
| Tiervlei Trial Centre | Cape Town | 7530 | South Africa |
|
| Synopsis Research | Cape Town | 7708 | South Africa |
|
| Synergy Biomed Research Institute (SBRI) | East London | 5201 | South Africa |
|
| Aliwal Shoal Medical Centre | eMkhomazi | 4170 | South Africa |
|
| Fola Health | Johannesburg | 2091 | South Africa |
|
| Trident Clinical | Kimberley | 8301 | South Africa |
|
| Ubuntu Clinical Research Krugersdorp | Krugersdorp | 1739 | South Africa |
|
| Drs H & V Makan Centre for Diabetes | Lenasia | 1827 | South Africa |
|
| Be Part Research (PTY) LTD | Paarl | 7626 | South Africa |
|
| Emmed Research | Pretoria | 0002 | South Africa |
|
| Dr JM Engelbrecht Trial Site | Somerset West | 7130 | South Africa |
|
| Sheikh Khalifa Medical City | Abu Dhabi | 0000 | United Arab Emirates |
|
| NMC Abu Dhabi | Abu Dhabi | 6222 | United Arab Emirates |
|
| Tawam Hospital | Al Ain City | 15258 | United Arab Emirates |
|
| Emirates Hospital Dubai | Dubai | 0000 | United Arab Emirates |
|
| Dubai Hospital | Dubai | 7272 | United Arab Emirates |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001522 | Behavior, Animal |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729680 | orforglipron |
Not provided
Not provided
Not provided