A Study in Patients with Obesity and Obstructive Sleep Apnea

Phase 1

• Conditions: Obstructive sleep apnea; MedDRA version: 25.0Level: PTClassification code 10029983Term: Obstructive sleep apnoea syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-004551-16-CZ
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 206

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified