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Clinical Trials/NCT03905707
NCT03905707CompletedPhase 3

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

Zealand Pharma27 sites in 9 countries150 target enrollmentStarted: May 7, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
150
Locations
27
Primary Endpoint
Safety - Adverse Events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

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)

Study Design

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

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Glepaglutide SC injections twice weekly

Experimental

Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.

In this long term safety study, there is no placebo arm.

Intervention: glepaglutide (Drug)

Glepaglutide SC injections once weekly and placebo once weekly

Experimental

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.

Intervention: glepaglutide (Drug)

Outcomes

Primary Outcomes

Safety - Adverse Events

Time Frame: 2 years

Incidence and type of Adverse Events

Secondary Outcomes

  • Safety - Changes in blood pressure from baseline(2 years)
  • Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)(2 years)
  • Energy content (amino acids)(2 years)
  • Safety - Serious Adverse Events(2 years)
  • Immunogenicity - Occurrence of anti-drug antibodies(2 years)
  • Number of patients with 40 percent change in PS volume per week(2 years)
  • Change in weekly Parenteral Support (PS) volume(2 years)
  • Days off PS(2 years)
  • Weaned off PS(2 years)
  • Energy content (lipids)(2 years)
  • Days on PS(2 years)
  • Safety - Adverse Events of Special Interest(2 years)
  • Number of patients with 20 percent reduction in PS volume(2 years)
  • Changes in fluid composite effect(2 years)
  • Energy content (glucose)(2 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (27)

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