Health Trials

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

ConditionsSleep Apnea, ObstructiveObesityOverweight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eloralintide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: Eloralintide (YSA1)Experimental treatment 1 intervention
Group B: Placebo (YSA1)Placebo comparator 1 intervention
Group C: Eloralintide (YSA2)Experimental treatment 1 intervention
Group D: Placebo (YSA2)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 64
2

Change from Baseline in Apnea-Hypopnea Index (AHI)

Time frame
Baseline, Week 64

Secondary outcomes

1

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame
Baseline, Week 64
2

Percent Change from Baseline in Triglycerides

Time frame
Baseline, Week 64
3

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

Time frame
Baseline, Week 64
4

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

Time frame
Baseline, Week 64

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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