A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan
- Registration Number
- NCT06635057
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- Have HbA1c ≥7% within 30 days prior to screening
- Are glucagon-like peptide-1 receptor agonist (GLP-1 RA) naïve
- Have had stable body weight self-reported change ≤5 kilograms (kg) during the 90 days prior to screening
- Have body mass index ≥25 kilograms per square meter (kg/m2) at screening
- Have Type 1 Diabetes or gestational diabetes
- Have a history of chronic or acute pancreatitis
- Have acute or chronic hepatitis
- Have evidence of a significant, uncontrolled endocrine abnormality
- Have a history of an active or untreated malignancy
- Have New York Heart Association Functional Classification IV congestive heart failure
- Have been treated with insulin within two weeks prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will receive tirzepatide subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR Number of Hypoglycemic Events Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR Number of Self-Reported Gastrointestinal (GI) Adverse Events Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR Percentage of Participants Achieving HbA1c <7% Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L) SoR (Week 0), EoR (Week 4)
Trial Locations
- Locations (20)
King Fahad Armed Forces
🇸🇦Jeddah, Al Andalus, Saudi Arabia
Saudi Airlines Medical services
🇸🇦Jeddah, AlKhalidiyyah, Saudi Arabia
Dr Sulaiman Al Habib Medical Group-Olaya
🇸🇦Riyadh, Alolaya, Saudi Arabia
Dr Sulaiman Al Habib Medical Group-Alsuwaidi
🇸🇦Riyadh, Alsuwaidi,Riyadh, Saudi Arabia
Dr Sulaiman Al Habib Medical Group-Arrayan
🇸🇦Riyadh, Ar Rayyan, Saudi Arabia
Dallah Hospitals
🇸🇦Riyadh, Nakheel, Riyadh, Saudi Arabia
King Abdulaziz Medical City-Alahsa
🇸🇦Alahsa, Saudi Arabia
King Abdulaziz Medical City-Jeddah
🇸🇦Jeddah, Saudi Arabia
King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
ICLDC
🇦🇪Abu Dhabi, United Arab Emirates
NMC Speciality Hospital
🇦🇪Abu Dhabi, United Arab Emirates
Rashid Center for Diabetes&Research
🇦🇪Ajman, United Arab Emirates
Thumbay University Hospital
🇦🇪Ajman, United Arab Emirates
Aster Clinics
🇦🇪Dubai, United Arab Emirates
Dubai Diabetes Center
🇦🇪Dubai, United Arab Emirates
Dubai Hospital
🇦🇪Dubai, United Arab Emirates
Medcare Hospital
🇦🇪Dubai, United Arab Emirates
Mediclinic City Hospital
🇦🇪Dubai, United Arab Emirates
Rashid Hospital
🇦🇪Dubai, United Arab Emirates
Al Moosa Hospital
🇸🇦Alahsa, Al Mubarraz, Saudi Arabia