A Phase 2 Trial Testing ZP1848 in Patients With SBS

NCT02690025 | Completed Phase 2

• 1 other identifier: ZP1848-15073
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (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.

  3 weeks

Secondary Outcomes (14)

• 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

Study Arms (3)

ZP1848 High dose

EXPERIMENTAL

s.c. administration of high dose

Drug: ZP1848

ZP1848 Medium dose

EXPERIMENTAL

s.c. administration of medium dose

Drug: ZP1848

ZP1848 Low dose

EXPERIMENTAL

s.c. administration of low dose

Drug: ZP1848

Interventions

ZP1848 DRUG

ZP1848 High dose; ZP1848 Low dose; ZP1848 Medium dose

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead
• Larix A/S: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (3)

• 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.

  PMID: 34287979 DERIVED

• 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.

  PMID: 31326433 DERIVED

• 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.

  PMID: 30880176 DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gertrud Koefoed Rasmussen, MSc

  Zealand Pharma A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 24, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)