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

Part of paid clinical trials in Riverside, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05412004
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Jun 21, 2022
Status verified
Apr 2025
Primary completion
Mar 12, 2024
Completion
Mar 29, 2024

Study Design

Enrollment
469 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide MTD_GPI1
    Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks
  • Placebo Comparator: Placebo_GPI1
    Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
  • Experimental: Tirzepatide MTD_GPI2
    Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks
  • Placebo Comparator: Placebo_GPI2
    Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

Primary Outcome Measure

Change From Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline, Week 52 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Artemis Institute for Clinical ResearchRiversideCalifornia92503-
Teradan Clinical Trials, LLCBrandonFlorida33511-
Renstar Medical ResearchOcalaFlorida34470-
Palm Beach Research CenterWest Palm BeachFlorida33409-
NeuroTrials Research IncAtlantaGeorgia30328-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Brengle Family MedicineIndianapolisIndiana46260-
Lillestol ResearchFargoNorth Dakota58104-
NeuroScience Research CenterCantonOhio44718-
CTI-CRCCincinnatiOhio45212-
Office 18PittsburghPennsylvania15236-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
FutureSearch Trials of NeurologyAustinTexas78731-
Gadolin ResearchBeaumontTexas77702-
Advanced Neuro Research Center - ANRCEl PasoTexas79912-
Epic Medical ResearchRed OakTexas75154-
Sleep Therapy Research CenterSan AntonioTexas78229-
Rainier Clinical Research CenterRentonWashington98057-

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