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

Lilly

Status and phase

Active, not recruiting

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06635057

I8F-MC-GPIY (Other Identifier)

27195

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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