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

Phase 3

Recruiting

• Conditions: Short Bowel Syndrome
• Interventions: Drug: glepaglutide

• Registration Number: NCT03905707
• Lead Sponsor: Zealand Pharma

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 Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-05
• Study Start: 2019-05-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 145

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glepaglutide SC injections twice weekly	glepaglutide	Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm.
Glepaglutide SC injections once weekly and placebo once weekly	glepaglutide	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.

Primary Outcome Measures

Name	Time	Method
Safety - Adverse Events	2 years	Incidence and type of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Safety - Changes in blood pressure from baseline	2 years	Changes in systolic and diastolic blood pressure will be reported
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)	2 years	Number of patients with clinically significant changes in ECG will be reported
Energy content (amino acids)	2 years	Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline
Number of patients with 40 percent change in PS volume per week	2 years	Achieving 40 percent in PS volume from baseline
Safety - Serious Adverse Events	2 years	Incidence and type of Serious Adverse Events
Immunogenicity - Occurrence of anti-drug antibodies	2 years	Occurrence of antibodies against glepaglutide
Change in weekly Parenteral Support (PS) volume	2 years	Change in weekly PS volume from baseline
Days off PS	2 years	Achieving 1 or more days per week off PS
Weaned off PS	2 years	Reduction in weekly PS volume of 100 percent (weaned off)
Energy content (lipids)	2 years	Change in lipids content (in kcal/L or kjoule/L) of PS from baseline
Days on PS	2 years	Change in number of days on PS per week from baseline
Safety - Adverse Events of Special Interest	2 years	Incidence and type of Adverse Events of Special Interest
Number of patients with 20 percent reduction in PS volume	2 years	Achieving at least 20 percent reduction in weekly PS volume from baseline
Changes in fluid composite effect	2 years	Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Energy content (glucose)	2 years	Change in glucose content (in kcal/L or kjoule/L) of PS from baseline

Trial Locations

Locations (27)

St Mark's Hospital; 🇬🇧 Harrow, United Kingdom

Mayo Clinic College of Medicine; 🇺🇸 Rochester, Minnesota, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University of Chicago Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Vanderbilt University Medical Center, Nashville; 🇺🇸 Nashville, Tennessee, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

The Royal Alexandra Hospital; 🇨🇦 Edmonton, Canada

Western University; 🇨🇦 London, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Canada

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Hôpital Beaujon; 🇫🇷 Clichy, France

Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite, France

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Universitätsklinikum Frankfurt - Med. Klinik I; 🇩🇪 Frankfurt, Germany

Asklepios Kliniken Hamburg GmbH; 🇩🇪 Hamburg, Germany

Universitätsmedizin Rostock; 🇩🇪 Rostock, Germany

UMC Radboud Nijmegen; 🇳🇱 Nijmegen, Netherlands

Solumed; 🇵🇱 Poznań, Poland

Szpital Skawina sp. z o.o. im. Stanley Dudricka; 🇵🇱 Skawina, Poland

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi; 🇵🇱 Łódź, Poland

UCLH Foundation NHS Trust; 🇬🇧 London, United Kingdom

University of East Anglia; 🇬🇧 Norwich, United Kingdom

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, United Kingdom