A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan

Launched by ELI LILLY AND COMPANY · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tirzepatide, which is being tested in people with Type 2 Diabetes who plan to fast during Ramadan. The main goal is to see if starting tirzepatide before Ramadan can help manage diabetes effectively throughout the fasting month. The study is currently active but not recruiting new participants, and it includes individuals aged 65 to 74 years old, regardless of gender.

To be eligible for this trial, participants need to have uncontrolled Type 2 Diabetes and have a specific blood sugar level (measured by HbA1c) of 7% or higher. They should also not have used certain diabetes medications before and must have a stable weight. However, people with Type 1 Diabetes, certain liver or pancreas problems, or severe heart issues are not allowed to participate. If someone joins the study, they can expect to use tirzepatide as part of their diabetes management during Ramadan, under the guidance of healthcare professionals. It's important to remember that this trial aims to find out how well the medication works in this specific situation, which could help improve diabetes care for those who fast.

Gender

ALL

Eligibility criteria

• 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