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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06635057

Acronym

T-RAM

Enrollment

166

Registered

2024-10-10

Start date

2024-10-11

Completion date

2026-04-15

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Ramadan, Fasting

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.

Interventions

DRUGTirzepatide

Administered SC

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)

Secondary

Measure	Time frame
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)

Countries

Saudi Arabia, United Arab Emirates

Contacts

STUDY_DIRECTORCall 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026