T-RAM

CompletedPhase 4

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

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

166

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06635057

Org study ID27195

Secondary IDI8F-MC-GPIYEli Lilly and Company

Timeline

Milestones

Study first posted2024-10-10actual

Study start2024-10-11actual

Primary completion2026-04-15actual

Study completion2026-04-15actual

Last update posted2026-05-22actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7%

Time frame:Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

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)

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Hypoglycemic Events

Time frame:Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

event count, event

Secondary/protocol endpoint

Number of Self-Reported Gastrointestinal (GI) Adverse Events

Time frame:Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.