GLP-1 Avexitide Continues To Current Promise In Lowering Hypoglycemia After Bariatric Surgical Process In Half II Trials

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

New Half II outcomes reveal very important reductions in excessive hypoglycemia

In a Half IIb analysis (NCT04652479), avexitide at a dose of 90 mg as quickly as every day demonstrated a 64% least-squares suggest low cost (p=0.0031) versus baseline inside the composite cost of Stage 2 and Stage 3 hypoglycemic events in PBH. Extra, higher than half of the people didn’t experience any events all through the treatment interval.

This trial moreover evaluated avexitide at 45 mg twice every day, which confirmed fixed reductions in composite cost of Stage 2 and Stage 3 hypoglycemic events.

PREVENT trial helps consistency all through lower doses

Within the meantime, new data from the Half II PREVENT trial (NCT03373435) moreover confirmed fixed reductions in composite cost of Stage 2 and Stage 3 hypoglycemic events, nonetheless at doses of 30 mg twice every day and 60 mg as quickly as every day.

LUCIDITY Half III trial to assemble on promising earlier data

Together with the model new Half II analyses of avexitide, Amylyx provided an exchange on its Half III LUCIDITY trial (NCT06747468) of avexitide. Primarily based on the company, LUCIDITY was educated by optimistic, fixed data stemming from 5 PBH analysis. Recruitment is predicted to be achieved this 12 months with the first data readout anticipated inside 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 Faculty, acknowledged: “Submit-bariatric hypoglycemia can profoundly disrupt every day life, requiring folks to fastidiously deal with meals, social interactions, and routines, sometimes whereas dwelling in fear of their subsequent hypoglycemic event. The model new analysis launched at ENDO 2025 continues to help that avexitide might significantly cut back the frequency of these events.”

Analysis design highlights for LUCIDITY trial

• LUCIDITY is a randomized, double-blind, placebo-controlled trial evaluating avexitide in victims with PBH after Roux-en-Y gastric bypass surgical process.
• The analysis will enroll roughly 75 people all through 20 US web sites.
• People could be randomized 3:2 to acquire each 90 mg avexitide subcutaneously as quickly as every day or placebo.
• The trial includes a screening interval of as a lot as six weeks, which features a three-week run-in, adopted by a 16-week double-blind treatment part.
• These ending the double-blind part might proceed in a 32-week open-label extension interval.
• The primary efficacy goal is to measure the low cost in Stage 2 and Stage 3 hypoglycemic events by 16 weeks, per FDA settlement.
• Additional assessments will embody safety and tolerability of avexitide.

Earlier Half II outcomes demonstrated strong efficacy and safety alerts

In July 2024, Amylyx acquired avexitide from Eiger BioPharmaceuticals. Furthermore, the treatment obtained Breakthrough Treatment Designation by the FDA for numerous indications along with PBH and congenital hyperinsulinism. On the time of the announcement, Amylyx shared earlier readouts from the Half II analysis of avexitide.²

Inside the Half II PREVENT analysis:

• Avexitide 30 mg and 60 mg twice every day elevated suggest glucose nadir by 21% and 26%, respectively, compared with placebo.
• Peak insulin ranges dropped by 23% inside the 30 mg group and 21% inside the 60 mg group, leading to 50% and 75% fewer people needing rescue treatment all through mixed meal tolerance checks.
• The treatment moreover resulted in notable reductions in hypoglycemia expenses all through all severity ranges (Ranges 1, 2, and three).

Inside the Half IIb trial of avexitide:

• The treatment hit its main endpoint, displaying a reduction in daytime Stage 2 hypoglycemia events (glucose
• Inside the 45 mg twice-daily group, hypoglycemia expenses decreased by:
  • 54% at Stage 1
  • 57% at Stage 2
  • 68% at Stage 3 (excessive events)
• Inside the 90 mg once-daily group, reductions have been:
  • 68% at Stage 1
  • 53% at Stage 2
  • 66% at Stage 3

References

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

2. Amylyx Pharmaceuticals Acquires Half III-Ready 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