A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan
T-RAM
A Phase 4, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Effectiveness and Safety of Tirzepatide Once Weekly in Adult Participants With Type 2 Diabetes During Ramadan
2 other identifiers
interventional
130
2 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Oct 2024
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedStudy Start
First participant enrolled
October 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJanuary 22, 2026
January 1, 2026
1.5 years
October 4, 2024
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)
Secondary Outcomes (5)
Percent Change from Baseline in Body Weight
Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Number of Hypoglycemic Events
Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Number of Self-Reported Gastrointestinal (GI) Adverse Events
Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Percentage of Participants Achieving HbA1c <7%
Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L)
SoR (Week 0), EoR (Week 4)
Study Arms (1)
Tirzepatide
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Al Moosa Specialist Hospital
Al Ahasa, 36342, Saudi Arabia
National Guard Hospital-King Abdulaziz Medical City
Alahsa, 36428, Saudi Arabia
King Abdulaziz Medical City-Jeddah
Jeddah, 21423, Saudi Arabia
King Fahad Armed Forces Hospital Jeddah
Jeddah, 21433, Saudi Arabia
King Faisal Specialist Hospital & Research Center
Jeddah, 21499, Saudi Arabia
Saudi Airlines Medical services
Jeddah, Saudi Arabia
King Faisal Specialist Hospital and Research Center Madina
Madinah, 42523, Saudi Arabia
King Saud University
Riyadh, 11472, Saudi Arabia
Osepdale Fatebenefratelli e Oftalmico
Riyadh, 11525, Saudi Arabia
Al Dallah Hospital
Riyadh, 11652, Saudi Arabia
Sulaiman Habib Olaya
Riyadh, 12214, Saudi Arabia
Specialized Medical Center Hospital
Riyadh, 12311, Saudi Arabia
Dallah Namar Hospital
Riyadh, 14963, Saudi Arabia
Dr. Sulaiman Al Habib Hospital As Suwaidi
Riyadh, 14963, Saudi Arabia
Dr. Sulaiman Al Habib Medical Complex Arrayan Saudi Arabia
Riyadh, Saudi Arabia
Lifecare Hospital
Abu Dhabi, 133500, United Arab Emirates
Tawam Hospital
Abu Dhabi, 34761, United Arab Emirates
Imperial College London Diabetes Center
Abu Dhabi, United Arab Emirates
NMC Abu Dhabi
Abu Dhabi, United Arab Emirates
Rashid Centre for Diabetes and Research
Ajman, United Arab Emirates
Thumbay University Hospital
Ajman, United Arab Emirates
Emirates Hospital Dubai
Dubai, 0000, United Arab Emirates
Aster Clinics
Dubai, United Arab Emirates
Dubai Diabetes Center
Dubai, United Arab Emirates
Dubai Hospital
Dubai, United Arab Emirates
Medcare Hospital
Dubai, United Arab Emirates
Mediclinic City Hospital
Dubai, United Arab Emirates
Rashid Hospital.
Dubai, United Arab Emirates
Medcare Hospital
Sharjah city, 0000, United Arab Emirates
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 10, 2024
Study Start
October 11, 2024
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.