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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Plain-language guide to NCT03311724: phase 2 randomized trial of Tirzepatide, 111 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03311724
- Phase
- phase 2
- Status
- completed
- Start
- 2017-10-19
- Completion (planned or actual)
- 2018-04-24
- Participants
- 111 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Tirzepatide.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 111 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017). Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.
The Tirzepatide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.
Those kept unaware of assignments: participant and investigator.
It started in 2017-10-19 with completion listed for 2018-04-24.
It ran at 13 sites in United States (13).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Haemoglobin A1c (HbA1c) (time frame: Baseline, 3 Months).
It also tracked 7 secondary outcomes, for example Change From Baseline in Fasting Blood Glucose (FBG), Change From Baseline in Body Weight, Change From Baseline in Waist Circumference, Number of Participants With Anti Drug Antibodies and Number of Episodes of Total Hypoglycemia Episodes.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tirzepatide in 111 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.