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NCT07369011: ENLIGHTEN-3
A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight
Phase 3 trial testing Eloralintide in Sleep Apnea, Obstructive in 800 participants. Currently enrolling.
1 March 2028
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 800 |
| Start date | 10 February 2026 |
| Primary completion | 1 March 2028 |
| Estimated completion | 1 April 2028 |
| Sites | 129 locations across United States, Argentina, Australia, Brazil, Canada, China, Germany, India |
Drugs / interventions tested
- Eloralintide — full drug profile →
- Placebo
Conditions studied
- Sleep Apnea, Obstructive — all drugs for Sleep Apnea, Obstructive →
- Obesity — all drugs for Obesity →
- Overweight — all drugs for Overweight →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
18 and older, any sex, with Sleep Apnea, Obstructive or Obesity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07369011
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eloralintide
Trials testing the same drug.
- NCT06916091 — A Study of Eloralintide (LY3841136) in Chinese Participants With Obesity or Overweight · Phase 1 · completed
- NCT06916065 — A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity · Phase 1 · completed
Other recruiting trials for Sleep Apnea, Obstructive
Currently open trials in the same condition.
- NCT06828835 — The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention · NA · recruiting
- NCT06915831 — Type 1 Diabetes and Obstructive Sleep Apnea · NA · recruiting
- NCT07176767 — The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents · recruiting
- NCT06573372 — Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea · recruiting
- NCT06848647 — Treatment of Sleep Apnea to Improve Metabolic Health · recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07369011 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 3 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07369011.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing