Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Eli Lilly and Company
Registry number NCT07369011
Started 10 February 2026 Today 16 October 2026 Estimated completion 1 March 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Nightingale Research Adelaide SA Recruiting
Flinders University Bedford Park SA Recruiting
Box Hill Hospital Box Hill VIC Recruiting
Core Research Group Brisbane QLD Recruiting
Austin Health - Repatriation Hospital Heidelberg West VIC Recruiting
CDH Research Institute Pty Ltd Maroochydore QLD Recruiting
Gold Coast University Hospital Southport QLD Recruiting
TrialsWest - Spearwood Spearwood WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 800

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 10 February 2026
Estimated completion 1 March 2028
Registry last updated 8 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 8 October 2026.
  • This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.