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Trial · Interventional

CompletedPhase 2Registry data

A Phase 2 Trial Testing ZP1848 in Patients With SBS

Short name glepaglutide

NCTNCT02690025 (opens ClinicalTrials.gov in a new tab)Other idZP1848-15073
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
18 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Feb 2016
Primary completion
May 2017
Completion
May 2017
First posted
24 Feb 2016 (estimated)
Last update posted
21 Jun 2017
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    glepaglutide

    NCT02690025

    Feb 2016 to May 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.

Interventions

  • ZP1848Drug

Arms3

  • Experimental

    ZP1848 High dose

    s.c. administration of high dose

  • Experimental

    ZP1848 Medium dose

    s.c. administration of medium dose

  • Experimental

    ZP1848 Low dose

    s.c. administration of low dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.

    Time frame · 3 weeks

Secondary outcomes(14)

  1. Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods

    Time frame · 3 weeks

  2. Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods

    Time frame · 3 weeks

  3. Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods

    Time frame · 3 weeks

  4. Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods

    Time frame · 3 weeks

  5. Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods

    Time frame · 3 weeks

  6. Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods

    Time frame · 3 weeks

  7. Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods

    Time frame · 3 weeks

  8. Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods

    Time frame · 3 weeks

  9. Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods

    Time frame · 3 weeks

  10. Change in SF-36 score

    Time frame · 3 weeks

  11. Incidence of Adverse Events

    Time frame · 15 weeks

  12. Incidence of Anti Drug Antibodies

    Time frame · 15 weeks

  13. Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods

    Time frame · 3 weeks

  14. Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods

    Time frame · 3 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2022

4 results

Bile acid-farnesoid X receptor-fibroblast growth factor 19 axis in patients with short bowel syndrome: The randomized, glepaglutide phase 2 trial.

Hvistendahl et al. 2022JPEN. Journal of parenteral and enteral nutritioncited by 14

PMID 34287979DOI 10.1002/jpen.2224PUB-34287979

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2019

22 results

Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial.

Naimi et al. 2019The lancet. Gastroenterology & hepatologycited by 60

PMID 30880176DOI 10.1016/s2468-1253(19)30077-9PUB-30880176

Full text at the publisher22 results
Publisher pageSee results (22)

Indexing hint: Randomized controlled trial · 2019

9 results

Effects of glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, on markers of liver status in patients with short bowel syndrome: findings from a randomised phase 2 trial.

Naimi et al. 2019EBioMedicinecited by 25

PMID 31326433PMC6710908DOI 10.1016/j.ebiom.2019.07.016PUB-31326433

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out. * Age ≥ 18 years and ≤ 90 years * Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago * A stable PS volume ( \< 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS * Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study. * Stable body weight (\<5% weight deviance in the three months prior to screening) Exclusion Criteria: * Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator * Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator. * Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization * Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening * History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded) * eGFR (by the MDRD formula) \<30 mL/min/1.73 m2 * Clinically meaningful renal disease as judged by the Investigator

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