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Funnel graphic depicting the prevalence of PBH in the United States. ~160,000 people are currently living with the condition.

Please refer to the corporate presentation deck for detailed sources.

Approximately 160,000 people in the U.S. are living with post-bariatric hypoglycemia (PBH), which is roughly 8% of those who have undergone the two most common types of bariatric surgery, Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy, over the last decade.1

Disease pathology and potential intervention2-17

PBH occurs, on average, 1-3 years post-bariatric surgery. PBH can cause severe hypoglycemia associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living.

PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. There are no approved therapies for PBH. Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels.

Amylyx program status

Avexitide is an investigational, first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and Orphan Drug Designation in hyperinsulinemic hypoglycemia, a condition characteristic of PBH. Avexitide has demonstrated highly statistically significant and clinically meaningful data with a well-tolerated safety profile across multiple clinical trials, with no discontinuations. In the previous Phase 2 study of 18 people who had PBH after RYGB surgery and the Phase 2b study of 16 people who had PBH following a variety of GI surgeries (including RYGB, sleeve gastrectomy, esophagectomy, Nissen fundoplication, and gastrectomy), treatment with avexitide during a 28-day treatment period led to statistically significant reductions in hypoglycemic events with a well-tolerated safety profile, including no discontinuations.

Chart demonstrating that avexitide reduced daily rates of hypoglycemia by greater than 50% in 2 Phase 2 PBH clinical trials.

In April 2025, the first participant was dosed in the Phase 3 LUCIDITY clinical trial of avexitide in people with PBH following RYGB surgery. Completion of enrollment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027. LUCIDITY is evaluating the FDA-agreed-upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16 and has similar inclusion and exclusion criteria to previous Phase 2 trials of avexitide in PBH.

  1. American Society for Metabolic and Bariatric Surgery (ASMBS). Estimate of Bariatric Surgery Numbers, 2013-2023. Accessed May 8, 2025. ASMBS total bariatric procedure numbers are based on the best available estimates from the most recent 10-year data (2013–2023) sources, including BOLD, ACS/MBSAQIP, National Inpatient Sample, and outpatient procedure estimates.
  2. Athavale A, Ganipisetti VM. Postbariatric Surgery Hypoglycemia. Updated August 15, 2023. https://www.ncbi.nlm.nih.gov/books/NBK592417/.
  3. Sheehan A, Patti ME. Diabetes Metab Syndr Obes. 2020;13:4469-4482.
  4. Salehi M et al. J Clin Endocrinol Metab. 2018;103(8):2815–2826.
  5. Heller SR, Cryer PE. Diabetes. 1991;40(2):223-226.
  6. Dagogo-Jack SE, et al. J Clin Invest. 1993;91(3):819-828.
  7. Karimi M, Kohandel Gargari O. Front Surg. 2024;11:1449012.
  8. Hazlehurst J, et al. Endocr Connect. 2024;13(5), e230285.
  9. Hemmingsson JU, et al. BMJ Open Diabetes Res Care. 2022;10(5):e002572.
  10. Patti ME, Goldfine A. Gastroenterology. 2014;146(3):605-608.
  11. Craig CM, et al. Diabetes Obes Metab. 2017; 1-10.
  12. Thorens B, et al. Diabetes.1993;42(11):1678-1682.
  13. Craig CM, et al. Diabetes Obes Metab. 2018;20(2):352-361.
  14. Smith NK, et al. Neurochem Int. 2019;128:94-105.
  15. Meloni AR, et al. Diabetes Obes Metab. 2013;15(1):15-27.
  16. Craig CM, et al. Diabetologia. 2017;60(3):531-540.
  17. Craig CM, et al. J Endocr Soc. 2022;6(Suppl 1):A349.

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