NCT03408132

CompletedPhase 1/2

Metabolic Balance Study of FE203799 in Patients With SBS Wit...

GlyPharma Therapeutics Source

GlyPharma Therapeutics

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

GLY-321-2017

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

May 2, 2018

Actual (reported)

Primary Completion

October 28, 2019

Actual (reported)

Study Completion

October 28, 2019

Actual (reported)

Brief Summary

This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE 203799 in 8 patients with SBS. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed after the fourth dose. Safety follow up assessments will be performed 4-6 weeks after the last dose.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: October 28, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 21, 2017
Actual (reported)
First Posted
January 23, 2018
Actual (reported)
Study Start
May 2, 2018
Actual (reported)
Primary Completion
October 28, 2019
Actual (reported)
Study Completion
October 28, 2019
Actual (reported)

Last Updated: October 24, 2024
Status Verified: February 2020
Last Update Submitted: October 23, 2024

Conditions

SBS - Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

Incidence of treatment-emergent adverse events
Adverse events as assessed by CTCAE v4.03
Day -28 to Day 26 plus 6 weeks

Secondary Outcomes (13)

Assessment of intestinal insufficiency and gut absorption
Day -28 to day 26
Assessment of intestinal insufficiency and gut absorption
Day -28 and day 26
Assessment of intestinal insufficiency and gut absorption
Day -28 and day 26
Assessment of intestinal insufficiency and gut absorption
Day -28 and day 26
Assessment of intestinal insufficiency and gut absorption
Day -28 to day 26 plus 6 weeks
+8 more secondary outcomes

Study Arms (1)

FE203799 5 mg

EXPERIMENTAL

FE203799 5 mg subcutaneous injection

Drug: FE203799

Interventions

FE203799Drug

FE203799 5 mg subcutaneous once weekly

Also known as: GLP 2 analogue

FE203799 5 mg

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females with SBS secondary to surgical resection of the small intestine, with or without an intact colon.
years of age

Sponsors & Collaborators

GlyPharma Therapeutics
Industrylead
VectivBio AG
Industrycollaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Tomasz Masior
VectivBio AG
STUDY DIRECTOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

January 23, 2018

Study Start

May 2, 2018

Actual (reported)

Average faecal wet weight excretion of ≥1500 g/day during the baseline balance study

Average urine production \<2000 mL/day during the baseline balance study

Body Mass Index (BMI) between 16.0 and 32.0 (both inclusive)

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. Gallstone with subsequent cholecystectomy to resolve the issues is acceptable.
Inflammatory bowel disease patients (IBD) 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
Decompensated heart failure (New York Heart Association \[NYHA\] class III-IV, see Appendix 12.2) 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 x ULN
Unplanned hospitalisation of \>24 hours duration within 1 month before the screening visit
+8 more criteria

Contact the study team to confirm eligibility.

Primary Completion

October 28, 2019

Actual (reported)

Study Completion

October 28, 2019

Actual (reported)

Last Updated

October 24, 2024

Record last verified: 2020-02

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03408132
Data provider: ClinicalTrials.gov
Source updated: 2024-10-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:34 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

FE203799 5 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations