Eloralintide: Trials and FDA Status
Eloralintide is a amylin agonist. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated
Where it stands
- US status
- Investigational
- Phase
- Phase 3
- Sponsor
- Eli Lilly
- Expected FDA decision
- None announced
- no primary source states a date (checked 2 Oct 2026)
- Trial IDs (NCT)
- NCT06230523, NCT07321886, NCT07282600
Results
Reported results
- 2025Phase 2 (Lancet 2025): weight change at 48 weeks (efficacy estimand)“The mean percent change in bodyweight from baseline after 48 weeks (efficacy estimand) was -9% (1 mg, 95% CI -12·6 to -6·3), -12% (3 mg, -14·9 to -9·8), -18% (6 mg, -20·7 to -14·5), -20% (9 mg, -22·7 to -17·5), -20% (6-9 mg, -22·7 to -17·0), and -16% (3-9 mg, -18·6 to -14·1), compared with -0·4% (-2·2 to 1·4) in the placebo group”pubmed.ncbi.nlm.nih.gov
Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.
Timeline
Milestones
- NCT07321886 (ENLIGHTEN-1; Phase 3): primary completion (estimated)
- NCT07282600 (ENLIGHTEN-2; Phase 3): primary completion (estimated)
- NCT07321886 (ENLIGHTEN-1; Phase 3): study start
- NCT07321886 (ENLIGHTEN-1; Phase 3): first posted on ClinicalTrials.gov
- Published in Diabetes, obesity & metabolism (2026): Eloralintide, a selective, long-acting amylin receptor agonist for treatment of obesity: Phase 1 proof of concept.
- NCT07282600 (ENLIGHTEN-2; Phase 3): first posted on ClinicalTrials.gov
- NCT07282600 (ENLIGHTEN-2; Phase 3): study start
- NCT06230523 (A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight; Phase 2): primary completion
- Published in Lancet (London, England) (2025): Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial.
- NCT06230523 (A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight; Phase 2): study start
- NCT06230523 (A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight; Phase 2): first posted on ClinicalTrials.gov
Sources
- 1A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (NCT06230523)ClinicalTrials.gov (U.S. National Library of Medicine) · 2024clinicaltrials.govAccessed 2 Oct 2026
- 2ENLIGHTEN-1: A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes (NCT07321886)ClinicalTrials.gov (U.S. National Library of Medicine) · 2026clinicaltrials.govAccessed 2 Oct 2026
- 3ENLIGHTEN-2: A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes (NCT07282600)ClinicalTrials.gov (U.S. National Library of Medicine) · 2025clinicaltrials.govAccessed 2 Oct 2026
- 4Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial.Lancet (London, England) · 2025PMID 41207310Accessed 2 Oct 2026
- 5Eloralintide, a selective, long-acting amylin receptor agonist for treatment of obesity: Phase 1 proof of concept.Diabetes, obesity & metabolism · 2026PMID 41559929Accessed 2 Oct 2026
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