Amylyx Pharmaceuticals has dosed the first subject in the randomised Phase III LUCIDITY trial of glucagon-like peptide-1 (GLP-1) receptor antagonist avexitide for treating post-bariatric hypoglycaemia (PBH).
The double-blind, multicentre, placebo-controlled trial aims to assess the safety and efficacy of the therapy in these individuals who have undergone Roux-en-Y gastric bypass (RYGB) surgery.
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It involves nearly 75 such subjects across 20 sites in the US. The primary endpoint, agreed upon with the US Food and Drug Administration (FDA), focuses on the decrease in the composite of level 2 and level 3 hypoglycaemic events through week 16, with tolerability and safety also under evaluation.
This study has inclusion and exclusion criteria similar to previous Phase II studies of the therapy in PBH.
Subjects will be randomised in a 3:2 ratio and will be given either 90mg of the therapy once a day subcutaneously or a placebo.
Up to six weeks of screening duration will be included in the trial, alongside a three-week run-in period, and a double-blind treatment phase for 16 weeks.
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By GlobalDataThose completing the double-blind phase will be qualified for a 32-week open-label extension period.
The current trial was built upon the therapy’s five previous trials’ data in PBH, which demonstrated the consistent, dose-dependent effects, as well as minimisations in hypoglycaemic events.
The safety profile of the therapy is claimed to be favourable and replicated across these trials.
Amylyx Pharmaceuticals chief medical officer Camille Bedrosian said: “With robust data generated to date from five previous clinical trials in PBH, we are excited about the potential for avexitide to address the persistent, recurrent, and debilitating hypoglycaemic events associated with PBH.”
Amylyx anticipates that its current cash reserves will sustain operations through the end of 2026. This financial stability is expected to support the completion of recruitment for the LUCIDITY trial by this year, with results anticipated in the first half of 2026.
Avexitide has been assessed in five Phase I and II trials for PBH and has also been under investigation for congenital hyperinsulinism (HI).
Recently, Amylyx dosed the first subject in the randomised Phase I LUMINA trial, which is assessing AMX0114 as a potential treatment for amyotrophic lateral sclerosis (ALS).
