A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Plain-language guide to NCT02759107: phase 1 randomized trial of Tirzepatide and Dulaglutide, 142 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02759107
Phase: phase 1
Status: completed
Start: 2016-05-11
Completion (planned or actual): 2017-06-26
Participants: 142 (actual)
Design: randomized, double-blind, basic_science
Conditions studied: Healthy; Type 2 Diabetes Mellitus (T2DM)
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Tirzepatide and Dulaglutide.

This study includes 3 parts (A, B and C).

It had seven arms (groups): Tirzepatide (Part A) (experimental), Placebo (Part A) (placebo comparator), Tirzepatide (Part B) (experimental), Placebo (Part B) (placebo comparator) and Dulaglutide (Part B) (active comparator).

The registry classes the interventions as drug.

Who Took Part

142 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C). Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: have known allergies to tirzepatide, glucagon-like peptide (glp)-1 analogs, or related compounds; have known allergies to tirzepatide, glp-1 analogs, or related compounds, or acetaminophen.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2016-05-11 with completion listed for 2017-06-26.

It ran at 2 sites in United States (1) and Singapore (1).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of Participants With One or More Serious Adverse Event(s) (SAEs) (time frame: Baseline through Day 43 (Part A) and Day 57 (Part B and C)).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide and Dulaglutide in 142 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.

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.