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

NCT03905707 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: ZP1848-17127
• Study Type: interventional
• Target: 145
• Locations: 9 countries
• Sites: 27

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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Safety - Adverse Events

  Incidence and type of Adverse Events

  2 years

Secondary Outcomes (15)

• Safety - Serious Adverse Events

  2 years

• Safety - Adverse Events of Special Interest

  2 years

• Safety - Changes in blood pressure from baseline

  2 years

• Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)

  2 years

• Immunogenicity - Occurrence of anti-drug antibodies

  2 years

Study Arms (2)

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.

Drug: glepaglutide

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.

Drug: glepaglutide

Interventions

glepaglutide DRUG

Glucagon-Like Peptide-2 (GLP-2) analog

Also known as: ZP1848

Glepaglutide SC injections once weekly and placebo once weekly; Glepaglutide SC injections twice weekly

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (27)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

University of Chicago Children's Hospital

Chicago, Illinois, 60637, United States

Location

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3285, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center, Nashville

Nashville, Tennessee, 68198-3285, United States

Location

UZ Leuven

Leuven, Belgium

Location

The Royal Alexandra Hospital

Edmonton, Canada

Location

Western University

London, N6A 4V2, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Canada

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Beaujon

Clichy, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Frankfurt - Med. Klinik I

Frankfurt, Germany

Location

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

UMC Radboud Nijmegen

Nijmegen, Netherlands

Location

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

Lodz, Poland

Location

Solumed

Poznan, Poland

Location

Szpital Skawina sp. z o.o. im. Stanley Dudricka

Skawina, Poland

Location

St Mark's Hospital

Harrow, United Kingdom

Location

UCLH Foundation NHS Trust

London, United Kingdom

Location

University of East Anglia

Norwich, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zealand Pharma

  Zealand Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 5, 2019
• Study Start: May 7, 2019
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CA (3); FR (2); PL (3); US (7); NL (1); DK (1); GB (4); DE (5); BE (1)