Glepaglutide

Glepaglutide (ZP1848)

Evidence & Status

  • Strong

Overview

Glepaglutide (ZP1848) is an investigational long-acting GLP-2 analog studied for short bowel syndrome with intestinal failure. In a randomized Phase 3 trial, twice-weekly treatment significantly reduced parenteral-support requirements compared with placebo, while the once-weekly regimen did not show statistically significant differences from placebo on the primary or key secondary endpoints. Glepaglutide is not FDA-approved.

Research Summary

In a 106-patient randomized Phase 3 trial, glepaglutide 10 mg twice weekly significantly reduced weekly parenteral-support volume compared with placebo at 24 weeks and showed significant benefits on key secondary parenteral-support endpoints. The once-weekly group did not show statistically significant differences versus placebo for the primary or key secondary endpoints. The publication assessed glepaglutide as generally safe and well tolerated, but adverse events and treatment discontinuations occurred and the trial does not establish universal or indefinite long-term safety.

Research Areas

  • Short bowel syndrome
  • Intestinal failure
  • Parenteral-support reduction
  • GLP-2 biology

Safety & Risks

Reported Side Effects

  • Adverse events and treatment discontinuations occurred in the Phase 3 trial
United States
Investigational; not FDA-approved
United Kingdom
Current authorization status not established in this record.
Australia
Current authorization status not established in this record.
Canada
Current authorization status not established in this record.

Citations & Sources