August 18, 2026
2 min read
Key takeaways:
- Avexitide lowered composite rates of level 2 and level 3 hypoglycemia by 55% more than placebo at 16 weeks.
- Amylyx Pharmaceuticals plans to submit a new drug application to the FDA by the end of 2026.
A once-daily GLP-1 receptor agonist decreased events of level 2 and level 3 hypoglycemia for adults after Roux-en-Y gastric bypass, according to topline results from a phase 3 trial.
Avexitide (Amylyx Pharmaceuticals) is a first-in-class GLP-1 that is being assessed to treat post-bariatric hypoglycemia, a condition that is thought to be caused by exaggerated GLP-1 response. According to a press release from Amylyx Pharmaceuticals, there are no currently approved therapies for post-bariatric hypoglycemia.
An investigational GLP-1 may reduce rates of post-bariatric hypoglycemia among adults who underwent gastric bypass surgery. Image: Adobe Stock
In the phase 3 LUCIDITY trial, researchers enrolled 78 adults who underwent gastric bypass surgery. Adults were randomly assigned, 3:2, to once-daily subcutaneous avexitide 90 mg or placebo for 16 weeks following a 3-week run-in period. The primary outcome was composite level 2 and level 3 hypoglycemic events at 16 weeks.
Adults receiving avexitide had a 55% greater reduction in the composite rate of level 2 and level 3 hypoglycemia events at 16 weeks compared with placebo (P = .000003). Additionally, the medication was also linked to reductions in level 2 hypoglycemia events as measured by self-monitoring blood glucose, level 2 hypoglycemia as measured by continuous glucose monitoring and independently adjudicated level 3 hypoglycemia events compared with placebo.
The safety profile of avexitide was similar to what was observed in other post-bariatric hypoglycemia trials of the drug. Diarrhea, injection site erythema and injection site bruising were the most common adverse events with the medication. Most adverse events were mild to moderate with avexitide, and no serious adverse events occurred. No changes in body weight were observed in either group during the trial.
“Post-bariatric hypoglycemia is a chronic metabolic condition that causes recurrent and often debilitating hypoglycemia, which has a significant negative impact on patients’ safety and quality of life,” Marilyn Tan, MD, FACE, clinical professor at Stanford University School of Medicine and principal investigator on the trial, said in a press release. “Level 2 and level 3 hypoglycemic events can be medical emergencies that result in significant cognitive or physical impairment, loss of consciousness, seizures and the need for assistance from others, underscoring the need for an FDA-approved treatment option. Preventing even one level 2 or level 3 event is medically meaningful. I am excited by the LUCIDITY results announced today and the potential to have the first treatment for patients with post-bariatric hypoglycemia.”
A 32-week open-label extension of the LUCIDITY trial is currently taking place. More data from LUCIDITY will be presented at an upcoming medical meeting. In the press release, Amylyx said it plans to submit a new drug application to the FDA by the end of 2026.
Sources/Disclosures
Source:
Disclosures:
Tan reports serving as a principal investigator of the LUCIDITY trial.
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