Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Purpose

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.

Condition

  • Short Bowel Syndrome

Eligibility

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

Inclusion Criteria

  • Signed informed consent; - Age of 18 to 90 years; - A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening); - Stable PS need of ≥3 days per week; - No restorative surgery planned during the trial period; - Having a stoma or colon in continuity.

Exclusion Criteria

  • More than 2 SBS- or PS-related hospitalizations within 6 months before screening; - Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial; - History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction; - BMI <18.5 kg/m^2.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants are randomly assigned to one of two groups (arms) in parallel: one group receives glepaglutide, and the other group receives a placebo. After this initial phase, both groups receive open-label treatment with glepaglutide.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Glepaglutide Group
  • Drug: Glepaglutide
    Subcutaneous (SC) injections twice weekly
    Other names:
    • ZP1848
Placebo Comparator
Placebo Group 		Placebo for glepaglutide
  • Other: Placebo
    SC injections twice weekly

Recruiting Locations

Washington University Center for Advanced Medicine
St Louis, Missouri 63110
Contact:
Matthew Ciorba, MD
314-273-4543
mciorba@wustl.edu

Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska 68105
Contact:
David Mercer
402-559-2556
dmercer@unmc.edu

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Dawn Adams
615-322-0128
dawn.w.adams@vanderbilt.edu

More Details

Status
Recruiting
Sponsor
Zealand Pharma

Study Contact

Detailed Description

The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).