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

NCT ID: NCT06635057

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-11

Study Completion Date

2026-04-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tirzepatide

Participants will receive tirzepatide subcutaneously (SC)

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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NMC Abu Dhabi

Abu Dhabi, , United Arab Emirates

Site Status

Al Moosa Specialist Hospital

Al Ahasa, , Saudi Arabia

Site Status

National Guard Hospital-King Abdulaziz Medical City

Alahsa, , Saudi Arabia

Site Status

King Abdulaziz Medical City-Jeddah

Jeddah, , Saudi Arabia

Site Status

King Fahad Armed Forces Hospital Jeddah

Jeddah, , Saudi Arabia

Site Status

King Faisal Specialist Hospital & Research Center

Jeddah, , Saudi Arabia

Site Status

Saudi Airlines Medical services

Jeddah, , Saudi Arabia

Site Status

King Faisal Specialist Hospital and Research Center Madina

Madinah, , Saudi Arabia

Site Status

King Saud University

Riyadh, , Saudi Arabia

Site Status

Osepdale Fatebenefratelli e Oftalmico

Riyadh, , Saudi Arabia

Site Status

Al Dallah Hospital

Riyadh, , Saudi Arabia

Site Status

Sulaiman Habib Olaya

Riyadh, , Saudi Arabia

Site Status

Specialized Medical Center Hospital

Riyadh, , Saudi Arabia

Site Status

Dallah Namar Hospital

Riyadh, , Saudi Arabia

Site Status

Dr. Sulaiman Al Habib Hospital As Suwaidi

Riyadh, , Saudi Arabia

Site Status

Dr. Sulaiman Al Habib Medical Complex Arrayan Saudi Arabia

Riyadh, , Saudi Arabia

Site Status

Lifecare Hospital

Abu Dhabi, , United Arab Emirates

Site Status

Tawam Hospital

Abu Dhabi, , United Arab Emirates

Site Status

Imperial College London Diabetes Center

Abu Dhabi, , United Arab Emirates

Site Status

Rashid Centre for Diabetes and Research

Ajman, , United Arab Emirates

Site Status

Thumbay University Hospital

Ajman, , United Arab Emirates

Site Status

Emirates Hospital Dubai

Dubai, , United Arab Emirates

Site Status

Aster Clinics

Dubai, , United Arab Emirates

Site Status

Dubai Diabetes Center

Dubai, , United Arab Emirates

Site Status

Dubai Hospital

Dubai, , United Arab Emirates

Site Status

Medcare Hospital

Dubai, , United Arab Emirates

Site Status

Mediclinic City Hospital

Dubai, , United Arab Emirates

Site Status

Rashid Hospital.

Dubai, , United Arab Emirates

Site Status

Medcare Hospital

Sharjah city, , United Arab Emirates

Site Status

Countries

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Saudi Arabia United Arab Emirates

Other Identifiers

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I8F-MC-GPIY

Identifier Type: OTHER

Identifier Source: secondary_id

27195

Identifier Type: -

Identifier Source: org_study_id

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