Amylyx drug cuts hypoglycemia events after bariatric surgery by 55% in Phase 3 trial
Key Facts
Amylyx Pharmaceuticals said on August 18, 2026, that its Phase 3 LUCIDITY trial of avexitide met its primary endpoint, with the composite rate of Level 2 and Level 3 hypoglycemia events falling 55% versus placebo, with a p-value of p=0.000003. The results concern hypoglycemia after bariatric surgery among participants who underwent Roux-en-Y surgery, not hyperinsulinemia generally. The company said the trial also met all secondary endpoints, with consistent, statistically significant reductions in Level 2 events measured by self-monitoring devices and continuous glucose monitoring, as well as Level 3 events. The company was scheduled to present the results orally at the ObesityWeek meeting in Washington on November 15, 2026. The scientific presentation therefore follows the results announcement in August; it is not a new announcement of the results in November.
LUCIDITY enrolled 78 participants at 21 sites in the United States and was designed as a randomized, double-blind, placebo-controlled trial. Researchers assigned participants in a 3:2 ratio to receive avexitide at 90 mg subcutaneously once daily or placebo. The double-blind treatment period lasted 16 weeks, followed by a 32-week open-label extension. The primary endpoint measured the change in the composite rate of Level 2 and Level 3 hypoglycemia events through week 16. The company said most adverse events were mild to moderate and that no serious treatment-related events were recorded during the double-blind study period. The most common adverse events included diarrhea, redness and bruising at the injection site. The trial observed no change in body weight in either group during that treatment period.
Avexitide is an investigational GLP-1 receptor antagonist. Amylyx says an excessive response to the hormone after bariatric surgery can lead to excess insulin secretion and recurrent hypoglycemia. The company estimates the condition may affect about 8% of people in the United States who have undergone the two most common types of bariatric surgery, or about 160,000 people. It added that there are currently no treatments for the condition approved by the U.S. Food and Drug Administration. Principal investigator Marilyn Tan said patients “want more than anything to reduce the number of hypoglycemic episodes so they can live independently and without fear.” The condition can cause cognitive impairment, loss of consciousness or seizures, according to Reuters. LUCIDITY’s design was based on data from five previous clinical trials of avexitide in people with hypoglycemia after bariatric surgery, which the company said showed consistent, statistically significant dose-related effects.
Amylyx shares moved 14.5% in after-hours trading on August 17, after the company announced a timetable for the trial readout; this revised an earlier timeline that had pointed to publication during the third quarter of 2026. On the day the results were announced, the stock rose more than 45%, according to Reuters. The agency quoted a Stifel analyst saying the size of the reduction was better than investors’ expectations and describing it as “the best possible scenario.” These moves provide context for the market’s response to the announcement, while the reported clinical result remains a reduction in the composite rate of hypoglycemia events versus placebo. In August, the company had completed a public stock offering with net proceeds of about $544.6 million. Amylyx said the funding strengthens its commercial readiness for a potential launch of the drug in 2027.
Amylyx said the U.S. Food and Drug Administration granted avexitide Breakthrough Therapy designation for hypoglycemia after bariatric surgery, but the drug remains investigational and cannot be launched commercially without regulatory approval. The company is targeting submission of a new drug application to the agency by the end of 2026. A potential commercial launch in 2027 remains contingent on approval. The company also said the LUCIDITY open-label extension and an expanded-access program for eligible adults are ongoing. The open-label extension lasts 32 weeks, according to the announced trial design. The oral presentation of the results was scheduled for November 15, 2026, at the ObesityWeek meeting in Washington, D.C.