Glepaglutide

Does Glepaglutide work?

Partly: one trial of 106 people with mixed results, so the FDA asked for another.

One randomised placebo-controlled phase 3 trial in 106 patients with short bowel syndrome met its primary endpoint in the more frequent dosing arm but not the less frequent one, and the FDA judged that insufficient for approval. That is one positive trial with a split result, so the grade is B. ¹²

EASE SBS 1 randomised 106 adults with short bowel syndrome. They needed parenteral support at least three days a week. They got glepaglutide at two dosing frequencies or placebo for 24 weeks. The group on the more frequent dosing cut its weekly parenteral support volume by 5.13 litres. The placebo group cut it by 2.85 litres. That gap was statistically significant. The group on less frequent dosing improved in number but not significantly. The FDA pointed to this gap. ¹

A separate phase 3b study took place at one center and was open-label. It gave 10 patients glepaglutide once weekly. It measured absorption directly with metabolic balance studies. At 24 weeks, energy absorption rose by about 1,038 kJ a day. The rise in wet-weight absorption, the main measure, narrowly missed significance. By week 52, parenteral support volume had fallen by about 800 mL a day. Body weight stayed stable. Most of the authors work for or consult for Zealand Pharma. ²

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Reference information only, not medical advice. Drawn from the Glepaglutide article, fact-checked against the cited sources. No dosing anywhere on this site.