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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Plain-language guide to NCT03131687: phase 2 randomized trial of Tirzepatide and Dulaglutide, 318 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03131687
- Phase
- phase 2
- Status
- completed
- Start
- 2017-05-24
- Completion (planned or actual)
- 2018-08-01
- Participants
- 318 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Tirzepatide and Dulaglutide.
It had six arms (groups): Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
The registry classes the interventions as drug.
Who Took Part
318 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 had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification. Have a body mass index (BMI) ≥23 and \<50 kilograms per square meter.
How the Study Was Run
Design: 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.
As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2017-05-24 with completion listed for 2018-08-01.
It ran at 49 sites in United States (35), Poland (6), Slovakia (5) and Puerto Rico (3).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 16 secondary outcomes, for example Change From Baseline to Week 26 in HbA1c, Change From Baseline to Week 12 in HbA1c, Change From Baseline in Body Weight, Change From Baseline in Fasting Blood Glucose, Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) and Change From Baseline in Total Cholesterol.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tirzepatide and Dulaglutide in 318 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 and the Dulaglutide compound page, all human trials.
Our Notes on the Compounds
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
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.