Amylyx Pharmaceuticals reports successful Phase 3 trial of avexitide, potentially paving the way for the first approved treatment for post-bariatric hypoglycaemia, affecting around 160,000 patients in the US.
Amylyx Pharmaceuticals said its experimental drug avexitide met the main goal in a pivotal late-stage study of post-bariatric hypoglycaemia, a complication that can cause dangerous and repeated blood sugar crashes after weight-loss surgery. The company said the result supports plans to seek approval for the treatment, which it sees as a possible first medicine for the condition.
According to Amylyx, the Phase 3 LUCIDITY trial enrolled 78 adults who had developed the disorder after Roux-en-Y gastric bypass surgery. The study was designed to measure whether avexitide could reduce severe hypoglycaemic episodes over 16 weeks. Amylyx has previously said the trial was built to reflect earlier Phase 2 work and was intended to support a possible commercial launch in 2027 if the data were positive.
Post-bariatric hypoglycaemia is estimated by Amylyx to affect about 160,000 people in the United States. The company says the disorder is linked to an exaggerated GLP-1 response after surgery, which can trigger excessive insulin release and unstable blood glucose levels. Avexitide is designed as a GLP-1 receptor antagonist, meaning it blocks the hormone’s action rather than amplifying it, as many obesity drugs do.
The company has also moved to broaden access while it prepares for the next stage of development. Amylyx opened a US expanded access programme for adults with serious unmet need who cannot take part in the trial, and it has said its cash position should support operations through potential commercialisation and into 2028. Topline data from LUCIDITY had been expected in the third quarter of 2026, and the latest announcement suggests the company is now positioning avexitide for a regulatory filing if the full dataset holds up.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
