Obstructive sleep apnea MedDRA version: 25.0 Level: PT Classification code 10029983 Term: Obstructive sleep apnoea syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •BMI =30 kg/m2 •Previously diagnosed moderate-to-severe OSA with an AHI =15, as diagnosed with PSG, home sleep apnea test (HSAT), or other method that meets local guidelines prior to screening •AHI =15 on PSG as part of the trial at screening •=18 years old •Participants who are unwilling or unable to use PAP therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 82 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 124
Exclusion criteria
Exclusion criteria: •T1DM or T2DM, history of ketoacidosis, or hyperosmolar state/coma •Laboratory evidence diagnostic of diabetes mellitus during screening, including HbA1c =6.5% (=48 mmol/mol) •Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening) •Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months •Used GLP-1 <3 months prior to Screening •Use stimulants <3 months prior to Screening (e.g., monafinil, armodafinil, solriamfetol, pitolisant, amphetamine, dextroamphetamine, dexmethylphenidate, methylphnidate, lisdexampfetamine) •Current use or likely to require, in the opinion of the investigator, concurrent treatment with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular or inhaled preparations) in the next 12 months. •Current or history of (<3 months prior to screening) treatment with medications that may cause significant weight gain •Taken medications or alternative remedies intended to promote weight loss <3 months prior to Screening •Have history of use of marijuana within 3 months of enrollment and unwillingness to abstain from marijuana use during trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that QW (once weekly) tirzepatide at the MTD (maximum-tolerated dose) (10 mg or 15 mg) is superior to placebo for mean percent decrease in AHI (Apnea-Hypopnea Index). ;Secondary Objective: To demonstrate that QW (once weekly.) tirzepatide at the MTD (maximum-tolerated dose;) (10 mg or 15 mg) is superior to placebo fo •Change in AHI (Apnea-Hypopnea Index) •A hierarchical assessment of patient-reported outcomes •Clinically meaningful change in AHI (Apnea-Hypopnea Index) •Achieving OSA remission or mild nonsymptomatic OSA (Obstructive Sleep Apnea) •Change in body weight •Change in inflammatory status •Change in SBP (systolic blood pressure);Primary end point(s): Percent change in AHI from baseline to week 52;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): From baseline in Week 52 Change in AHI A hierarchical composite of the following: •Change in FOSQ (Functional Outcomes of Sleep Questionnaire)-10 score •Change in FOSQ (30 items) Vigilance domain score •Change in FOSQ (30 items) Activity Level domain score Percent of participants with =50% AHI reduction Percent of participants with •AHI <5 or •AHI 5-14 with ESS =10 Percent change in body weight Change in hsCRP concentration From baseline to Week 48 ( BP will be assessed at Week 48 because PAP suspension at Week 52 may compound BP assessment.) Change in SBP ;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Australia, Brazil, China, Czechia, Czech Republic, Germany, Japan, Mexico, Taiwan, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed