Clinical Trials in India / NCT07613307
Recruiting
Phase 3
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
NCT07613307 · tracked via the Priya Life Science India tracker
Condition(s) studied
Diabetes Mellitus, Type 2Diabetes MelletusGlucose Metabolism DisordersMetabolic DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehaviorFastingGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsReceptors, Peptide
Study summary
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.
Eligibility
Inclusion Criteria:
* Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.
* Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening.
* Intend to be compliant with the fast during the Ramadan period.
* Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.
* Have body mass index (BMI) of 25 kilograms per meter square (kg/m2) or higher at screening.
Exclusion Criteria:
* Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes
* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
* Have a history of chronic or acute pancreatitis any time prior to screening
* Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
* Have a history of cholecystectomy (surgically removed gallbladder)
* Have New York Heart Association Functional Classification IV congestive heart-failure.
Primary outcome measure(s)
- Change from Baseline in Hemoglobin A1C (HbA1c) — Baseline, up to 8 Weeks after Start of Ramadan
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarojini Naidu Medical College | Agra | India | Recruiting |
| Osmania General Hospital | Hyderabad | India | Recruiting |
| Brij Medical Centre Pvt. Ltd. | Kanpur | India | Recruiting |
| Apollo Multispeciality Hospitals limited | Kolkata | India | Recruiting |
| KGN Diabetes and Endocrinology Centre | Mumbai | India | Recruiting |
| Mysore Medical College and Research Institute | Mysore | India | Recruiting |
| Supe Heart & Diabetes Hospital & Research Centre | Nashik | India | Recruiting |
| Diabetes Clinic | Nellore | India | Recruiting |
| Visakha Institute of Medical Sciences | Visakhapatna | India | Recruiting |
| King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs | Al-Ahsa | Saudi Arabia | Not Yet Recruiting |
| King Fahad Specialist Hospital | Dammam | Saudi Arabia | Recruiting |
| Imam Abdulrahman Bin Faisal University | Dammam | Saudi Arabia | Recruiting |
| National Guard Health Affairs: King Abdulaziz Medical City | Jeddah | Saudi Arabia | Not Yet Recruiting |
| King Abdulaziz University Hospital | Jeddah | Saudi Arabia | Recruiting |
| King Fahad Armed Forces Hospital Jeddah | Jeddah | Saudi Arabia | Not Yet Recruiting |
| Dr. Soliman Fakeeh Hospital | Jeddah | Saudi Arabia | Recruiting |
| King Saud University Medical City | Riyadh | Saudi Arabia | Recruiting |
| Dr. Soliman Fakeeh Hospital | Riyadh | Saudi Arabia | Not Yet Recruiting |
| Osepdale Fatebenefratelli e Oftalmico | Riyadh | Saudi Arabia | Not Yet Recruiting |
| JOSHA Research | Bloemfontein | South Africa | Recruiting |
| TREAD Research | Cape Town | South Africa | Recruiting |
| TASK Central | Cape Town | South Africa | Recruiting |
| Tiervlei Trial Centre | Cape Town | South Africa | Recruiting |
| Synopsis Research | Cape Town | South Africa | Recruiting |
| Synergy Biomed Research Institute (SBRI) | East London | South Africa | Recruiting |
| Aliwal Shoal Medical Centre | eMkhomazi | South Africa | Recruiting |
| Fola Health | Johannesburg | South Africa | Recruiting |
| Trident Clinical | Kimberley | South Africa | Recruiting |
| Ubuntu Clinical Research Krugersdorp | Krugersdorp | South Africa | Recruiting |
| Drs H & V Makan Centre for Diabetes | Lenasia | South Africa | Recruiting |
| Be Part Research (PTY) LTD | Paarl | South Africa | Recruiting |
| Emmed Research | Pretoria | South Africa | Recruiting |
| Dr JM Engelbrecht Trial Site | Somerset West | South Africa | Recruiting |
| Burjeel Medical City | Abu Dhabi | United Arab Emirates | Not Yet Recruiting |
| NMC Royal hospital | Abu Dhabi | United Arab Emirates | Recruiting |
| Sheikh Khalifa Medical City | Abu Dhabi | United Arab Emirates | Recruiting |
| NMC Abu Dhabi | Abu Dhabi | United Arab Emirates | Recruiting |
| Tawam Hospital | Al Ain City | United Arab Emirates | Recruiting |
| Emirates Hospital Dubai | Dubai | United Arab Emirates | Not Yet Recruiting |
| Dubai Hospital | Dubai | United Arab Emirates | Recruiting |
More Eli Lilly and Company trials in India
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07613307 on ClinicalTrials.gov ↗ ← All trials in India