Amylyx Pharmaceuticals (NASDAQ: AMLX) Is on Track for the Registrational Phase 3 LUCIDITY Trial Top-Line Data Readout in Late August or Early September 2026, Having Completed the Final Study Visit in the 16-Week Double-Blind Period of the Trial That Enrolled 78 Patients With Post-Bariatric Hypoglycemia (PBH) Across 21 US Sites and Randomized Them 3:2 to Avexitide 90 mg Subcutaneous Once Daily or Placebo; The FDA-Agreed-Upon Primary Endpoint Is Reduction in the Composite of Level 2 and Level 3 Hypoglycemic Events Through Week 16; The Trial Design Was Informed by Data From Five Prior Clinical Trials of Avexitide in PBH That Consistently Showed Statistically Significant Reductions in Level 2 and Level 3 Hypoglycemic Events; If Positive, Commercial Launch of Avexitide (Exendin 9-39, a Peptide GLP-1 Receptor Antagonist) Is Anticipated in 2027 for the Indication With No Currently Approved Drug Therapy
Amylyx Pharmaceuticals (NASDAQ: AMLX) is on track for the registrational Phase 3 LUCIDITY trial top-line data readout in late August or early September 2026. Trial status: the last participant completed the final study visit in the 16-week double-blind period. Trial design: 78 patients with post-bariatric hypoglycemia (PBH) enrolled across 21 US sites and randomized 3:2 to avexitide 90 mg subcutaneous once daily or placebo for 16 weeks. Primary endpoint (agreed with the FDA): reduction in the composite of Level 2 (blood glucose < 54 mg/dL) and Level 3 (severe cognitive impairment requiring external assistance) hypoglycemic events through Week 16. The trial design was informed by data from five prior clinical trials of avexitide in post-bariatric hypoglycemia that consistently showed statistically significant reductions in Level 2 and Level 3 hypoglycemic events. Avexitide is exendin (9-39), a peptide GLP-1 receptor antagonist that binds the GLP-1 receptor without activating it, blocking excessive endogenous GLP-1 signaling that drives postprandial hypoglycemia in patients following Roux-en-Y gastric bypass surgery. If positive, commercial launch of avexitide is anticipated in 2027 for the indication that has no currently approved drug therapy. LUCIDITY is one of the most-watched near-term peptide-specific clinical catalysts and one of very few Phase 3 programs targeting a GLP-1 receptor antagonist rather than agonist mechanism.