Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome

Conditions

• Short Bowel Syndrome (SBS)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Glepaglutide 10 mg — DRUG
  Administered twice weekly by subcutaneous injection for a maximum of 24 months

Study Details

The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.

Key Dates

Start date

Dec 11, 2025

Status verified

Jan 2026

Primary completion

Sep 18, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

35 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Open-label Glepaglutide

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline to the safety follow-up visit (A maximum of 25 months) ]

Locations (4)

Find similar trials in Rochester, MN

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