GLP-1 Avexitide Continues to Present Promise in Decreasing Hypoglycemia After Bariatric Surgical procedure in Part II Trials

Amylyx has introduced new exploratory analyses from two Part II medical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the remedy of post-bariatric hypoglycemia (PBH). These knowledge have been introduced on the Endocrine Society’s annual assembly (ENDO 2025).¹

New Part II outcomes reveal vital reductions in extreme hypoglycemia

In a Part IIb research (NCT04652479), avexitide at a dose of 90 mg as soon as each day demonstrated a 64% least-squares imply discount (p=0.0031) versus baseline within the composite charge of Stage 2 and Stage 3 hypoglycemic occasions in PBH. Additional, greater than half of the individuals didn’t expertise any occasions throughout the remedy interval.

This trial additionally evaluated avexitide at 45 mg twice each day, which confirmed constant reductions in composite charge of Stage 2 and Stage 3 hypoglycemic occasions.

PREVENT trial helps consistency throughout decrease doses

In the meantime, new knowledge from the Part II PREVENT trial (NCT03373435) additionally confirmed constant reductions in composite charge of Stage 2 and Stage 3 hypoglycemic occasions, however at doses of 30 mg twice each day and 60 mg as soon as each day.

LUCIDITY Part III trial to construct on promising earlier knowledge

Along with the brand new Part II analyses of avexitide, Amylyx supplied an replace on its Part III LUCIDITY trial (NCT06747468) of avexitide. Based on the corporate, LUCIDITY was knowledgeable by optimistic, constant knowledge stemming from 5 PBH research. Recruitment is predicted to be accomplished this 12 months with the primary knowledge readout anticipated within the first half of 2026. If avexitide is permitted, Amylyx expects industrial launch in 2027.

In a press launch, Marilyn Tan, MD, FACE, principal investigator of the LUCIDITY trial and medical affiliate professor at Stanford College, stated: “Submit-bariatric hypoglycemia can profoundly disrupt each day life, requiring people to fastidiously handle meals, social interactions, and routines, typically whereas dwelling in worry of their subsequent hypoglycemic occasion. The brand new evaluation introduced at ENDO 2025 continues to assist that avexitide could considerably scale back the frequency of those occasions.”

Research design highlights for LUCIDITY trial

• LUCIDITY is a randomized, double-blind, placebo-controlled trial evaluating avexitide in sufferers with PBH after Roux-en-Y gastric bypass surgical procedure.
• The research will enroll roughly 75 individuals throughout 20 US websites.
• Individuals might be randomized 3:2 to obtain both 90 mg avexitide subcutaneously as soon as each day or placebo.
• The trial features a screening interval of as much as six weeks, which includes a three-week run-in, adopted by a 16-week double-blind remedy section.
• These finishing the double-blind section could proceed in a 32-week open-label extension interval.
• The first efficacy objective is to measure the discount in Stage 2 and Stage 3 hypoglycemic occasions by 16 weeks, per FDA settlement.
• Further assessments will embody security and tolerability of avexitide.

Earlier Part II outcomes demonstrated robust efficacy and security alerts

In July 2024, Amylyx acquired avexitide from Eiger BioPharmaceuticals. Moreover, the remedy obtained Breakthrough Remedy Designation by the FDA for various indications together with PBH and congenital hyperinsulinism. On the time of the announcement, Amylyx shared earlier readouts from the Part II research of avexitide.²

Within the Part II PREVENT research:

• Avexitide 30 mg and 60 mg twice each day elevated imply glucose nadir by 21% and 26%, respectively, in comparison with placebo.
• Peak insulin ranges dropped by 23% within the 30 mg group and 21% within the 60 mg group, resulting in 50% and 75% fewer individuals needing rescue remedy throughout combined meal tolerance checks.
• The remedy additionally resulted in notable reductions in hypoglycemia charges throughout all severity ranges (Ranges 1, 2, and three).

Within the Part IIb trial of avexitide:

• The remedy hit its major endpoint, displaying a discount in daytime Stage 2 hypoglycemia occasions (glucose
• Within the 45 mg twice-daily group, hypoglycemia charges decreased by:
  • 54% at Stage 1
  • 57% at Stage 2
  • 68% at Stage 3 (extreme occasions)
• Within the 90 mg once-daily group, reductions have been:
  • 68% at Stage 1
  • 53% at Stage 2
  • 66% at Stage 3

References

1. Amylyx Prescribed drugs Presents New Exploratory Analyses from Part 2 and Part 2b Scientific Trials of Avexitide in Submit-Bariatric Hypoglycemia at ENDO 2025. Information launch. Amylyx Prescribed drugs. July 13, 2025. Accessed July 15, 2025. https://www.businesswire.com/information/residence/20250713408050/en/Amylyx-Prescribed drugs-Presents-New-Exploratory-Analyses-from-Part-2-and-Part-2b-Scientific-Trials-of-Avexitide-in-Submit-Bariatric-Hypoglycemia-at-ENDO-2025

2. Amylyx Prescribed drugs Acquires Part III-Prepared GLP-1 Receptor Agonist Avexitide for Hyperinsulinemic Hypoglycemia from Eiger BioPharmaceuticals. Pharmaceutical Govt. July 12, 2024. Accessed July 15, 2025. https://www.pharmexec.com/view/amylyx-pharmaceuticals-acquires-phase-iii-ready-glp-1-receptor-agonist-avexitide-hyperinsulinemic-hypoglycemia-eiger-biopharmaceuticals