A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan (NCT06635057) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan
Saudi Arabia130 participantsStarted 2024-10-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Change from Baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)