A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Phase 3Not Yet RecruitingNCT07369011

Eli Lilly and Company800 enrolled

Overview

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

800

Conditions

Sleep Apnea, Obstructive Obesity Overweight

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed history of moderate-to-severe OSA * Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening * Have a BMI ≥27 kg/m2 at screening * Have a stable body weight (\<5% body weight change) for 90 days prior to screening * Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight For YSA1 Participants: * Are unable or unwilling to use PAP therapy For YSA2 Participants: * Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study Exclusion Criteria: * Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \>1 year before screening) * Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening) * Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening * Have type 1 diabetes, type 2 diabetes, or any other type of diabetes * Have had within 90 days prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * coronary artery revascularization * unstable angina, or * hospitalization due to congestive heart failure * Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure * Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Locations (122)

Cullman Clinical Trials

Cullman, Alabama, United States

Ark Clinical Research

Long Beach, California, United States

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Care Access - Aurora

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 64

Change from Baseline in Apnea-Hypopnea Index (AHI)

Time frame: Baseline, Week 64

Secondary Outcomes

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 64

Percent Change from Baseline in Triglycerides

Time frame: Baseline, Week 64

Percent Change from Baseline in High Sensitivity C-Reactive Protein (hsCRP)

Time frame: Baseline, Week 64

Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-Score

Time frame: Baseline, Week 64

Achievement of AHI <5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10

Time frame: Baseline, Week 64

Percent Change from Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)

Time frame: Baseline, Week 64

Number of Participants who Achieve ≥50% decrease in AHI

Time frame: Baseline, Week 64

Change from Baseline in Body Mass Index (BMI)

Time frame: Baseline, Week 64

Change from Baseline in Fasting Glucose

Time frame: Baseline, Week 64

Change from Baseline in ESS Score

Time frame: Baseline, Week 64

Change from Baseline in Short Form-36 (SF-36 v2) Scores

Time frame: Baseline, Week 64

Change from Baseline in EQ-5D-5L Scores

Time frame: Baseline, Week 64

Percent Change from Baseline in Fasting Insulin

Time frame: Baseline, Week 64

Change from Baseline in Waist Circumference

Time frame: Baseline, Week 64

Change in Medication Use

Time frame: Baseline, Week 64

Achievement of Improved Categorical Shift in Patient Global Impression of Severity-Obstructive Sleep Apnea (PGIS-OSA)

Time frame: Baseline, Week 64

Pharmacokinetics (PK): Maximum Concentration at Steady State (Cmax,ss)

Time frame: Baseline through Week 64

PK: Area Under the Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

Time frame: Baseline through Week 64

Central Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com