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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-20

No results posted yet for this study

Summary

The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.

Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Glepaglutide

Subcutaneous (SC) injections twice weekly

OTHER

Placebo

SC injections twice weekly

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2028-10-23
Completion
2032-02-28
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07197944 on ClinicalTrials.gov