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A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Plain-language guide to NCT06047548: phase 3 randomized trial of Tirzepatide, 441 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06047548
- Phase
- phase 3
- Status
- completed
- Start
- 2023-09-20
- Completion (planned or actual)
- 2026-01-20
- Participants
- 441 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Overweight; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Tirzepatide.
Participants will receive tirzepatide subcutaneously (SC).
Participants will receive tirzepatide SC.
Participants will receive placebo.
The registry classes the interventions as drug.
Who Took Part
441 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 Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:. Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW).
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: have type 1 diabetes (t1d) or type 2 diabetes (t2d), a history of ketoacidosis, or hyperosmolar state or coma; have a self-reported change in bw\>5 kilogram (kg) within 3 months prior to screening; have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed \>1 year prior to screening.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind 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.
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 2023-09-20 with completion listed for 2026-01-20.
It ran at 20 sites in United States (20).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 7 secondary outcomes, for example Percent Change from Baseline in Body Weight, Change from Randomization in Body Weight, Percent Change from Randomization in Body Weight and Change from Randomization in Waist Circumference.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Tirzepatide in 441 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.