A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

Plain-language guide to NCT03987919: phase 3 randomized trial of Tirzepatide and Semaglutide, 1879 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03987919
Phase: phase 3
Status: completed
Start: 2019-07-30
Completion (planned or actual): 2021-01-28
Participants: 1879 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Tirzepatide and Semaglutide.

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes.

The study will last approximately 47 weeks and may include about 12 visits.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

1879 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 been diagnosed with type 2 diabetes mellitus (T2DM). Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to study entry; have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

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.

It started in 2019-07-30 with completion listed for 2021-01-28.

It ran at 127 sites in United States (51), United Kingdom (14), Argentina (13), Australia (13), Israel (9) and Canada (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) ([amount hidden]).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Semaglutide in 1879 people.

With 1879 participants it is a large trial for this field.

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 Semaglutide 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.

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

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.