Efficacy and safety of avexitide for treatment of hypoglycemia following bariatric and other upper gastrointestinal surgeries: a phase 2b study.
Colleen Craig, Marilyn Tan, Termeh Shamloo et al.
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In 30 seconds
This phase 2b randomised controlled study evaluated avexitide in adults with clinically important hypoglycemia after Roux-en-Y gastric bypass, sleeve gastrectomy, total gastrectomy, or Nissen fundoplication. Sixteen participants completed a 14-day baseline period and two 14-day treatment periods, receiving avexitide 45 mg twice daily and 90 mg once daily in random order. Compared with baseline, the regimens reduced diurnal Level 2 hypoglycemia events measured by continuous glucose monitoring by 47.7% and 59.0%, respectively (both p ≤ 0.0001). Treatment was well tolerated, with no serious adverse events or adverse-event-related discontinuations.
Key findings
- Diurnal Level 2 events by continuous glucose monitoring fell by 47.7% with 45 mg twice daily and 59.0% with 90 mg once daily (both p ≤ 0.0001).
- Level 3 events decreased by 67.5% and 66.1% with the two regimens, respectively (both p = 0.0003).
- Avexitide 90 mg once daily improved HFS-II Total Score (p = 0.0095) and EQ-5D-5L Index Score (p = 0.0067).
- No serious adverse events occurred, and no participants discontinued because of adverse events.
Why it matters
Hypoglycemia after bariatric and other upper gastrointestinal surgery can involve recurrent severe episodes and neuroglycopenic events. These findings suggest that GLP-1 receptor antagonism may reduce measured hypoglycemia across several surgical groups, with quality-of-life improvements also reported for one regimen. The results provide clinical evidence for further evaluation of a targeted approach in this population.
What to keep in mind
Only 16 participants completed the study, and each treatment period lasted 14 days; the abstract does not establish longer-term efficacy or safety.