Glepaglutide for Short Bowel Syndrome

(EASE SBS 3 Trial)

Recruiting at 19 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Zealand Pharma

Must not be taking: GLP-1, GLP-2, HGH, DPP-4

Disqualifiers: Pregnancy, Breast-feeding, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

129 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if glepaglutide is safe and effective for people with Short Bowel Syndrome (SBS) over a long period. Participants will receive regular injections under the skin to see if it helps their intestines absorb nutrients better. Glepaglutide is a new treatment being tested for its effectiveness in patients with short bowel syndrome.

Research Team

Zealand Pharma

Principal Investigator

Zealand Pharma

Eligibility Criteria

This trial is for individuals who have completed the EASE SBS 2 trial for Short Bowel Syndrome (SBS) and are not using certain other medications or treatments. Women must use effective contraception if of childbearing potential, and participants should not have any conditions that may interfere with the study.

Inclusion Criteria

Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)

Informed consent obtained before any trial-related activity

Exclusion Criteria

I haven't had a colonoscopy at the end of the EASE SBS 2 trial, or it was safe.

I haven't used GLP-1, GLP-2, HGH, DPP-4 inhibitors, or somatostatin in the last 3 months.

I am not pregnant, breastfeeding, planning to become pregnant, or using effective birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mg of glepaglutide as once-weekly injections under the skin for approximately 2 years

104 weeks

Once-weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Glepaglutide

Trial Overview The study tests the long-term safety and effectiveness of glepaglutide in treating SBS. Participants will receive weekly subcutaneous injections of glepaglutide over a period of approximately two years.

Participant Groups

Group I: once-weekly glepaglutide Experimental Treatment 1 Intervention

All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Who Is Running the Clinical Trial?

Zealand Pharma

Lead Sponsor

Trials

41

Recruited

3,400+