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

Plain-language guide to NCT06635057: phase 4 interventional trial of Tirzepatide, 166 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06635057
Phase
phase 4
Status
completed
Start
2024-10-11
Completion (planned or actual)
2026-04-15
Participants
166 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Type 2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Tirzepatide.

It had 1 arm (groups): Tirzepatide (experimental).

Participants will receive tirzepatide subcutaneously (SC).

The registry classes the interventions as drug.

Who Took Part

The registry lists 166 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. 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.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: have type 1 diabetes or gestational diabetes; have a history of chronic or acute pancreatitis; have acute or chronic hepatitis.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-10-11 with completion listed for 2026-04-15.

It ran at 29 sites in Saudi Arabia (15) and United Arab Emirates (14).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main 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 also tracked 5 secondary outcomes, for example Percent Change from Baseline in Body Weight, Number of Hypoglycemic Events, Number of Self-Reported Gastrointestinal (GI) Adverse Events and Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Tirzepatide in 166 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.