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Trial · Interventional

CompletedPhase 4Registry data

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

Short name T-RAM

NCTNCT06635057 (opens ClinicalTrials.gov in a new tab)Other id27195Other idI8F-MC-GPIY
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
166 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

Saudi Arabia, United Arab Emirates

Start
11 Oct 2024
Primary completion
15 Apr 2026
Completion
15 Apr 2026
First posted
10 Oct 2024
Last update posted
22 May 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 4

    T-RAM

    NCT06635057

    11 Oct 2024 to 15 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • TirzepatideDrug

Arms1

  • Experimental

    Tirzepatide

    Participants will receive tirzepatide subcutaneously (SC)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

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

Secondary outcomes(5)

  1. Percent Change from Baseline in Body Weight

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

  2. Number of Hypoglycemic Events

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

  3. Number of Self-Reported Gastrointestinal (GI) Adverse Events

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

  4. Percentage of Participants Achieving HbA1c <7%

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

  5. 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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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