Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

What Was Tested

The trial (phase 3) is built around Tirzepatide for sleep apnea (obstructive).

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.

It had four arms (groups): Tirzepatide MTD_GPI1 (experimental), Placebo_GPI1 (placebo comparator), Tirzepatide MTD_GPI2 (experimental) and Placebo_GPI2 (placebo comparator).

Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

469 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 an AHI ≥15 on PSG as part of the trial at screening. Have a body mass index (BMI) ≥30 kilogram/square meter (kg/m²). Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: are unwilling to stop pap therapy for 7 days prior to polysomnography (psg) testing during the course of the study; female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed; have type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm), history of ketoacidosis, or hyperosmolar state/coma.

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.

Groups ran in parallel: each of the sleep apnea (obstructive) participants stayed in one arm throughout.

Neither the sleep apnea (obstructive) participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2022-06-21 with completion listed for 2024-03-12.

It ran at 58 sites in United States (18), Mexico (8), Germany (7), Brazil (6), China (6) and Japan (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Apnea-Hypopnea Index (AHI) (time frame: Baseline, Week 52).

It also tracked 8 secondary outcomes, for example Percent Change From Baseline in Apnea-Hypopnea Index (AHI), Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10, Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour), Percent Change From Baseline in Body Weight, Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration and Change From Baseline in Systolic Blood Pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 469 people with sleep apnea (obstructive).

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page, Sleep apnea (obstructive) research.