A Phase 2 Trial Testing ZP1848 in Patients With SBS

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Trial Testing ZP1848 in Patients With SBS

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Drug: ZP1848


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZP1848 High dose<br>s.c. administration of high dose | Drug: ZP1848<br> <br> |
| Experimental: ZP1848 Medium dose<br>s.c. administration of medium dose | Drug: ZP1848<br> <br> |
| Experimental: ZP1848 Low dose<br>s.c. administration of low dose | Drug: ZP1848<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 3 weeks | 
| Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods |  | 3 weeks | 
| Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods |  | 3 weeks | 
| Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods |  | 3 weeks | 
| Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods |  | 3 weeks | 
| Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods |  | 3 weeks | 
| Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods |  | 3 weeks | 
| Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods |  | 3 weeks | 
| Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods |  | 3 weeks | 
| Change in SF-36 score |  | 3 weeks | 
| Incidence of Adverse Events |  | 15 weeks | 
| Incidence of Anti Drug Antibodies |  | 15 weeks | 
| Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods |  | 3 weeks | 
| Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods |  | 3 weeks |