Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support

NCT03415594 | Completed Phase 1

• 1 other identifier: GLY-311-2017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Part A:once weekly dosing for 4 weeks in patients with short bowel syndrome who require total parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they will enter period 2 (active treatment and placebo); Part B: treatment period 3, is an open label extension to part A and starts after a washout of 6-10 weeks after the last dose in treatment period 2. patients are dosed once weekly for 4 weeks.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Adverse events (AEs) as assessed by CTCAE v4.03

  Day -28 to Day 29

Secondary Outcomes (10)

• Assessment of intestinal failure and gut absorption

  Day -3 - Day 28

• Assessment of intestinal failure and gut absorption

  Day -3 - Day 28

• Assessment of intestinal failure and gut absorption

  Day -3 - Day 29

• Assessment of intestinal failure and gut absorption

  Day -3 - Day 28

• Assessment of intestinal failure and gut absorption

  Day -3 and Day 29

Study Arms (3)

FE203799 5 mg

EXPERIMENTAL

FE203799 GLP-2 analogue, once weekly, subcutaneous administration

Drug: FE203799 GLP-2 analogue

Placebo

PLACEBO COMPARATOR

Placebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration

Drug: FE203799 Placebo GLP-2 analogue

FE203799 10 mg

OTHER

FE203799 GLP-2 analogue, once weekly, subcutaneous administration

Drug: FE203799 GLP-2 analogue

Interventions

FE203799 GLP-2 analogue DRUG

FE203799 5 mg subQ once weekly

FE203799 5 mg

FE203799 Placebo GLP-2 analogue DRUG

Placebo subQ once weekly

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females with SBS secondary to surgical resection of small intestine
• years of age
• Body Mass Index (BMI) between 16.0 and 32.0
• Patients with a jejuno- or ileostomy and a faecal wet weight excretion of at least 1500 g/day, as recorded within the last 18 months according to the patient's medical record
• Parenteral support ≥3 times/week for ≥12 months according to the patient's medical record
• At least 6 months since last surgical bowel resection
• Willing to adhere to a defined oral intake of fluids on certain days as required by the protocol (and based on the individual's routine daily consumption)
• Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 60 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea and confirmed with follicle-stimulating hormone \[FSH\] test)

You may not qualify if:

• Pregnancy or lactation
• Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests
• A history of clinically significant intestinal adhesions and/or chronic abdominal pain
• Require chronic systemic narcotics for treatment of pain that exceeds an amount corresponding to 80 mg of morphine per day
• History of cancer or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer
• History of gallstone within the past 3 years. Gallstones with subsequent cholecystectomy to resolve the issues is acceptable
• Inflammatory bowel disease (IBD) patients who have NOT been on a stable drug treatment regimen for at least the past 4 weeks
• Evidence of active IBD in the past 12 weeks
• Visible blood in the stool within the last 3 months
• Catheter sepsis experienced within the last 3 months
• Decompensated heart failure (New York Heart Association \[NYHA\] class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
• Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue
• History of alcohol and/or drug abuse within the last 12 months
• Inadequate hepatic function as defined by: bilirubin \>upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) \>2.0 × ULN; alkaline phosphatase (ALP) \>2.5 × ULN; or international normalised ratio (INR) \>1.5 × ULN
• Inadequate renal function as defined by serum creatinine or blood urea nitrogen \>2.5 × ULN

Sponsors & Collaborators

• GlyPharma Therapeutics: lead
• VectivBio AG: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Eliasson J, Hvistendahl MK, Freund N, Bolognani F, Meyer C, Jeppesen PB. Apraglutide, a novel glucagon-like peptide-2 analog, improves fluid absorption in patients with short bowel syndrome intestinal failure: Findings from a placebo-controlled, randomized phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):896-904. doi: 10.1002/jpen.2223. Epub 2021 Sep 7.

  PMID: 34287970 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

• Tomasz Masior

  VectivBio AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: January 30, 2018
• Study Start: May 8, 2018
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: October 26, 2024

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)