A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Plain-language guide to NCT05822830: phase 3 randomized trial of Tirzepatide and Semaglutide, 751 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05822830
Phase: phase 3
Status: completed
Start: 2023-04-21
Completion (planned or actual): 2024-11-13
Participants: 751 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Obesity; Overweight
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Tirzepatide and Semaglutide.

The study will last around 74 weeks.

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

The registry classes the interventions as drug.

Who Took Part

751 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 history of at least 1 unsuccessful dietary effort to lose body weight.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: diabetes mellitus; change in body weight greater than 5 kg within 3 months prior to starting study; obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 2023-04-21 with completion listed for 2024-11-13.

It ran at 32 sites in United States (30) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change From Baseline in Body Weight (time frame: Baseline, Week 72).

It also tracked 8 secondary outcomes, for example Change From Baseline in Waist Circumference in Centimeter and Change From Baseline in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Semaglutide in 751 people.

With 751 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.