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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.