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

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

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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