A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
Recruiting · NCT07613307 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
40 locations listed.
- Burjeel Medical City - Abu Dhabi, United Arab Emirates
- NMC Royal hospital - Abu Dhabi, United Arab Emirates
- Sheikh Khalifa Medical City - Abu Dhabi, United Arab Emirates
- NMC Abu Dhabi - Abu Dhabi, United Arab Emirates
- Sarojini Naidu Medical College - Agra, India
- Tawam Hospital - Al Ain City, United Arab Emirates
- King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs - Al-Ahsa, Saudi Arabia
- JOSHA Research - Bloemfontein, South Africa
- TREAD Research - Cape Town, South Africa
- TASK Central - Cape Town, South Africa
- Tiervlei Trial Centre - Cape Town, South Africa
- Synopsis Research - Cape Town, South Africa
- King Fahad Specialist Hospital - Dammam, Saudi Arabia
- Imam Abdulrahman Bin Faisal University - Dammam, Saudi Arabia
- Emirates Hospital Dubai - Dubai, United Arab Emirates
- Dubai Hospital - Dubai, United Arab Emirates
- Synergy Biomed Research Institute (SBRI) - East London, South Africa
- Osmania General Hospital - Hyderabad, India
- National Guard Health Affairs: King Abdulaziz Medical City - Jeddah, Saudi Arabia
- King Abdulaziz University Hospital - Jeddah, Saudi Arabia
- King Fahad Armed Forces Hospital Jeddah - Jeddah, Saudi Arabia
- Dr. Soliman Fakeeh Hospital - Jeddah, Saudi Arabia
- Fola Health - Johannesburg, South Africa
- Brij Medical Centre Pvt. Ltd. - Kanpur, India
- Trident Clinical - Kimberley, South Africa
- Apollo Multispeciality Hospitals limited - Kolkata, India
- Ubuntu Clinical Research Krugersdorp - Krugersdorp, South Africa
- Drs H & V Makan Centre for Diabetes - Lenasia, South Africa
- KGN Diabetes and Endocrinology Centre - Mumbai, India
- Mysore Medical College and Research Institute - Mysore, India
- Supe Heart & Diabetes Hospital & Research Centre - Nashik, India
- Diabetes Clinic - Nellore, India
- Be Part Research (PTY) LTD - Paarl, South Africa
- Emmed Research - Pretoria, South Africa
- King Saud University Medical City - Riyadh, Saudi Arabia
- Dr. Soliman Fakeeh Hospital - Riyadh, Saudi Arabia
- Osepdale Fatebenefratelli e Oftalmico - Riyadh, Saudi Arabia
- Dr JM Engelbrecht Trial Site - Somerset West, South Africa
- Visakha Institute of Medical Sciences - Visakhapatna, India
- Aliwal Shoal Medical Centre - eMkhomazi, South Africa