Eloralintide

Selective amylin receptor agonist (long-acting) · Eli Lilly

Top dose

3/6/9 mg DE

Weight loss

-16.4%

at week 48 · efficacy

AE discontinuation

7.4%

Status

phase 2

Weight loss trajectory #

Pivotal trial #

Trial: Ph 2 (NCT06230523)
Indication: obesity (no T2D)
Duration: 48 weeks
ClinicalTrials.gov: NCT06230523
Sponsor: Eli Lilly

Dose-response: weight loss vs AE-led discontinuation #

Per-arm efficacy (bars, left axis) and AE-led discontinuation (dots, right axis) from Ph 2 (Billings Lancet 2025). Higher doses generally trade extra weight loss for worse tolerability.

Notes #

Phase shown reflects the DATA: the -16.4% is from the Phase 2 trial (NCT06230523, primary complete May 2025). The Ph3 ENLIGHTEN-1 (NCT07321886) is only recruiting. Lilly LY3841136, selective amylin (AMY1R) receptor agonist. Phase 2 Billings et al Lancet 2025 (efficacy estimand, wk 48). HEADLINE switched to the 3/6/9 mg dose-escalation regimen = -16.4% - the arm Lilly leads with in its ADA 2026 investor deck and advances to Phase 3 (the 5-trial ENLIGHTEN program). The 9 mg fixed arm gave -20.0% (95% CI -22.7 to -17.5, n=54) but with the worst GI burden (AE-disc 21% outlier at 6 mg; nausea up to 33%), so it over-flatters vs the developed regimen. Full dose-response (efficacy estimand): 1 mg -9%, 3 mg -12.4%, 6 mg -18%, 9 mg -20%, 3/6/9 DE -16.4%. All efficacy estimand (no ITT/treatment-policy reported). AE-led disc 4/54 (7.4%) vs placebo 7.7%. Adjacent Lilly use: Eloralintide as 'incretin add-on' to Mounjaro/Zepbound (separate Ph3).