A Phase 2 Trial Testing ZP1848 in Patients With SBS (glepaglutide)

Zealand Pharma logo

Zealand Pharma

Status and phase

Completed
Phase 2

Conditions

Short Bowel Syndrome

Treatments

Drug: ZP1848

Study type

Interventional

Funder types

Industry

Identifiers

NCT02690025
ZP1848-15073

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

18 participants in 3 patient groups

ZP1848 High dose
Experimental group
Description:
s.c. administration of high dose
Treatment:
Drug: ZP1848
ZP1848 Medium dose
Experimental group
Description:
s.c. administration of medium dose
Treatment:
Drug: ZP1848
ZP1848 Low dose
Experimental group
Description:
s.c. administration of low dose
Treatment:
Drug: ZP1848

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems