Short Bowel SyndromePhase 3EASE SBS 2NCT03905707
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
A Phase 3 study testing glepaglutide in people with Short Bowel Syndrome, run by Zealand Pharma at 27 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- glepaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 7 May 2019to 30 Apr 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activity
- Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)
Who cannot join
- 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
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
United States7 sites
University of Chicago Children's Hospital
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Vanderbilt University Medical Center, Nashville
Nashville, Tennessee, 68198-3285
Mount Sinai Hospital
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3285
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Germany5 sites
Charité - Universitätsmedizin Berlin
Berlin
Universitätsklinikum Bonn
Bonn, 53127
Universitätsklinikum Frankfurt - Med. Klinik I
Frankfurt
Asklepios Kliniken Hamburg GmbH
Hamburg
Universitätsmedizin Rostock
Rostock
United Kingdom4 sites
St Mark's Hospital
Harrow
UCLH Foundation NHS Trust
London
University of East Anglia
Norwich
University Hospital Southampton NHS Foundation Trust
Southampton
Canada3 sites
The Royal Alexandra Hospital
Edmonton
Western University
London, N6A 4V2
University Health Network - Toronto General Hospital
Toronto
Poland3 sites
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Lodz
Solumed
Poznan
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Skawina
About this study
Official title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)
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.
Read the 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)
- Conditions
- Short Bowel Syndrome
- Being tested
- glepaglutide
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glepaglutideDrug
Also called ZP1848
Glucagon-Like Peptide-2 (GLP-2) analog
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: glepaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Events
Incidence and type of Adverse Events
Measured: 2 years
Secondary outcomes (15)
Safety - Serious Adverse Events
Incidence and type of Serious Adverse Events
Measured: 2 years
Safety - Adverse Events of Special Interest
Incidence and type of Adverse Events of Special Interest
Measured: 2 years
Safety - Changes in blood pressure from baseline
Changes in systolic and diastolic blood pressure will be reported
Measured: 2 years
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)
Number of patients with clinically significant changes in ECG will be reported
Measured: 2 years
Immunogenicity - Occurrence of anti-drug antibodies
Occurrence of antibodies against glepaglutide
Measured: 2 years
Change in weekly Parenteral Support (PS) volume
Change in weekly PS volume from baseline
Measured: 2 years
Number of patients with 20 percent reduction in PS volume
Achieving at least 20 percent reduction in weekly PS volume from baseline
Measured: 2 years
Days off PS
Achieving 1 or more days per week off PS
Measured: 2 years
Weaned off PS
Reduction in weekly PS volume of 100 percent (weaned off)
Measured: 2 years
Changes in fluid composite effect
Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Measured: 2 years
Energy content (lipids)
Change in lipids content (in kcal/L or kjoule/L) of PS from baseline
Measured: 2 years
Energy content (glucose)
Change in glucose content (in kcal/L or kjoule/L) of PS from baseline
Measured: 2 years
Energy content (amino acids)
Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline
Measured: 2 years
Days on PS
Change in number of days on PS per week from baseline
Measured: 2 years
Number of patients with 40 percent change in PS volume per week
Achieving 40 percent in PS volume from baseline
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start7 May 2019
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zealand Pharma, Study director, Zealand Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905707
- Sponsor's protocol ID
- ZP1848-17127
- Acronym
- EASE SBS 2
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2019
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided