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

Primary Purpose

Short Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

ZP1848

About this trial

This is an interventional treatment trial for Short Bowel Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

ZP1848 High dose

ZP1848 Medium dose

ZP1848 Low dose

Arm Description

s.c. administration of high dose

s.c. administration of medium dose

s.c. administration of low dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

Change in SF-36 score

Incidence of Adverse Events

Incidence of Anti Drug Antibodies

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

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

Full Information

NCT ID

NCT02690025

First Posted

February 12, 2016

Last Updated

June 20, 2017

Sponsor

Zealand Pharma

Collaborators

Larix A/S

1. Study Identification

Unique Protocol Identification Number

NCT02690025

Brief Title

A Phase 2 Trial Testing ZP1848 in Patients With SBS

Acronym

glepaglutide

Official Title

A Phase 2 Trial Testing ZP1848 in Patients With SBS

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zealand Pharma

Collaborators

Larix A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ZP1848 High dose

Arm Type

Experimental

Arm Description

s.c. administration of high dose

Arm Title

ZP1848 Medium dose

Arm Type

Experimental

Arm Description

s.c. administration of medium dose

Arm Title

ZP1848 Low dose

Arm Type

Experimental

Arm Description

s.c. administration of low dose

Intervention Type

Drug

Intervention Name(s)

ZP1848

Primary Outcome Measure Information:

Title

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

Change in SF-36 score

Time Frame

3 weeks

Title

Incidence of Adverse Events

Time Frame

15 weeks

Title

Incidence of Anti Drug Antibodies

Time Frame

15 weeks

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gertrud Koefoed Rasmussen, MSc

Organizational Affiliation

Zealand Pharma A/S

Official's Role

Study Director

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34287979

Citation

Hvistendahl MK, Naimi RM, Hansen SH, Rehfeld JF, Kissow H, Pedersen J, Dragsted LO, Sonne DP, Knop FK, Jeppesen PB. Bile acid-farnesoid X receptor-fibroblast growth factor 19 axis in patients with short bowel syndrome: The randomized, glepaglutide phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):923-935. doi: 10.1002/jpen.2224. Epub 2021 Sep 1.

Results Reference

derived

PubMed Identifier

31326433

Citation

Naimi RM, Hvistendahl M, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Gronbaek H, Moller HJ, Vilstrup H, Steensberg A, Jeppesen PB. 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. EBioMedicine. 2019 Aug;46:444-451. doi: 10.1016/j.ebiom.2019.07.016. Epub 2019 Jul 17.

Results Reference

derived

PubMed Identifier

30880176

Citation

Naimi RM, Hvistendahl M, Enevoldsen LH, Madsen JL, Fuglsang S, Poulsen SS, Kissow H, Pedersen J, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Holst JJ, Hartmann B, Hansen SH, Dragsted LO, Steensberg A, Mouritzen U, Hansen MB, Jeppesen PB. Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2019 May;4(5):354-363. doi: 10.1016/S2468-1253(19)30077-9. Epub 2019 Mar 15.

Results Reference

derived

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A Phase 2 Trial Testing ZP1848 in Patients With SBS

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