Amylyx to reveal Phase 3 avexitide results for post-bariatric hypoglycaemia amid regulatory launch plans

Amylyx Pharmaceuticals is set to announce the topline results of its pivotal Phase 3 LUCIDITY trial testing avexitide, a potential treatment for post-bariatric hypoglycaemia, on 18 August, as the company prepares for a possible market launch in 2027.

Amylyx Pharmaceuticals is set to publish topline results from its Phase 3 LUCIDITY trial of avexitide on 18 August, the company said, marking a key moment for its effort to develop a treatment for post-bariatric hypoglycaemia. Senior executives plan to discuss the data on an investor call the same morning.

The late-stage study is testing avexitide in adults who continue to experience dangerous drops in blood sugar after Roux-en-Y gastric bypass surgery. Amylyx has described the trial as randomised, double-blind and placebo-controlled, with 78 participants enrolled, and has said it is assessing whether the drug can cut the number of clinically significant hypoglycaemic events over 16 weeks.

The upcoming readout follows a year of steady trial progress. Amylyx previously said the first participant was dosed in the first quarter of 2025 and later reported that enrolment had been completed in March 2026. The company has also said it is preparing for a possible launch in 2027, subject to regulatory approval.

Avexitide is being studied as an investigational GLP-1 receptor antagonist, a class of drug designed to block the activity of a hormone involved in insulin release and glucose control. Amylyx has also opened a US expanded-access programme for patients with serious unmet need, underscoring the limited treatment options currently available for the condition.

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