Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Purpose

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Condition

  • Short Bowel Syndrome

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Informed consent obtained before any trial-related activity - Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

Exclusion Criteria

  • Withdrawal of consent from the lead-in trial - Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results - Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening - Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Glepaglutide SC injections twice weekly 		Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm.
  • Drug: glepaglutide
    Glucagon-Like Peptide-2 (GLP-2) analog
    Other names:
    • ZP1848
Experimental
Glepaglutide SC injections once weekly and placebo once weekly 		Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly. In this long term safety study, there is no placebo arm.
  • Drug: glepaglutide
    Glucagon-Like Peptide-2 (GLP-2) analog
    Other names:
    • ZP1848

Recruiting Locations

Georgetown University Medical Center
Washington, District of Columbia 20007
Contact:
Medical Director
lbg@zealandpharma.com

More Details

Status
Recruiting
Sponsor
Zealand Pharma

Study Contact

Medical Director
+4588773600
lbg@zealandpharma.com

Detailed Description

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)