Type 2 DiabetesPhase 4T-RAMNCT06635057
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan
A Phase 4 study testing Tirzepatide in people with Type 2 Diabetes, run by Eli Lilly and Company at 29 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 11 Oct 2024to 15 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
Saudi Arabia15 sites
Al Moosa Specialist Hospital
Al Ahasa, 36342
National Guard Hospital-King Abdulaziz Medical City
Alahsa, 36428
King Abdulaziz Medical City-Jeddah
Jeddah, 21423
King Fahad Armed Forces Hospital Jeddah
Jeddah, 21433
King Faisal Specialist Hospital & Research Center
Jeddah, 21499
Saudi Airlines Medical services
Jeddah
King Faisal Specialist Hospital and Research Center Madina
Madinah, 42523
King Saud University
Riyadh, 11472
Osepdale Fatebenefratelli e Oftalmico
Riyadh, 11525
Al Dallah Hospital
Riyadh, 11652
Sulaiman Habib Olaya
Riyadh, 12214
Specialized Medical Center Hospital
Riyadh, 12311
Dallah Namar Hospital
Riyadh, 14963
Dr. Sulaiman Al Habib Hospital As Suwaidi
Riyadh, 14963
Dr. Sulaiman Al Habib Medical Complex Arrayan Saudi Arabia
Riyadh
United Arab Emirates14 sites
Lifecare Hospital
Abu Dhabi, 133500
Tawam Hospital
Abu Dhabi, 34761
Imperial College London Diabetes Center
Abu Dhabi
NMC Abu Dhabi
Abu Dhabi
Rashid Centre for Diabetes and Research
Ajman
Thumbay University Hospital
Ajman
Emirates Hospital Dubai
Dubai, 0000
Aster Clinics
Dubai
Dubai Diabetes Center
Dubai
Dubai Hospital
Dubai
Medcare Hospital
Dubai
Mediclinic City Hospital
Dubai
Rashid Hospital.
Dubai
Medcare Hospital
Sharjah city, 0000
About this study
Official title: 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Tirzepatide
- Keywords
- Ramadan, Fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC) Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: 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
Measured: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Number of Hypoglycemic Events
Measured: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Number of Self-Reported Gastrointestinal (GI) Adverse Events
Measured: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Percentage of Participants Achieving HbA1c <7%
Measured: 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)
Measured: SoR (Week 0), EoR (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start11 Oct 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635057
- Sponsor's protocol ID
- 27195
- Other IDs
- I8F-MC-GPIY
- Acronym
- T-RAM
- Status last verified
- May 2026
- First submitted
- 4 Oct 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06635057
- Acronym / sponsor ID
- T-RAM / 27195
- Conditions
- Type 2 Diabetes
- Keywords
- Ramadan, Fasting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants will receive tirzepatide subcutaneously (SC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide |
Primary outcome
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)
5 secondary outcomes
Percent Change from Baseline in Body Weight
Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Number of Hypoglycemic Events
Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Number of Self-Reported Gastrointestinal (GI) Adverse Events
Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
Percentage of Participants Achieving HbA1c <7%
Time frame: 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)
Time frame: SoR (Week 0), EoR (Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Type 2 Diabetes, run by Eli Lilly and Company at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Saudi Arabia, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.