Tirzepatide effectiveness and safety during Ramadan fasting to be investigated in Type 2 Diabetes

Type 2 Diabetes management is complex, especially during Ramadan fasting, where altered meal patterns and hydration can increase risks of hypoglycemia or hyperglycemia. Current treatments often require careful adjustment. GLP-1 receptor agonists (GLP-1 RA) and dual GIP/GLP-1 receptor agonists like tirzepatide offer significant HbA1c reduction and weight loss, but their safety and effectiveness when initiated before and used during Ramadan fasting, particularly regarding hypoglycemic risk and gastrointestinal adverse events, need specific investigation. This study addresses this critical gap for patients observing Ramadan.

This is a Phase 4, multicenter, multi-country, open-label, single-arm study. It will enroll an estimated 130 adult participants with Type 2 Diabetes who intend to fast during Ramadan and are GLP-1 RA naïve, with HbA1c ≥7%. Participants will receive tirzepatide subcutaneously (SC) once weekly per label. The primary endpoint is the change from baseline in Hemoglobin A1c (HbA1c) from baseline (20-8 weeks pre-Ramadan) to 4-8 weeks from the start of Ramadan. Secondary endpoints include body weight change, hypoglycemic events, and GI adverse events.

This is a study protocol, and as such, no results or findings are available yet. The study is currently active but not recruiting, with an estimated completion date of April 2026. The primary outcome will assess the change in HbA1c from baseline to 4-8 weeks post-Ramadan start. Secondary outcomes will track percent change in body weight, the number of hypoglycemic events, and self-reported gastrointestinal adverse events. The study also aims to determine the percentage of participants achieving HbA1c <7% and changes in quality of life (EQ-5D-5L). The core objective 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, with a focus on HbA1c control and safety.