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SBS - Short Bowel SyndromePhase 1/2NCT03408132

Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency

A Phase 1/2 study testing FE203799 in people with SBS - Short Bowel Syndrome, run by GlyPharma Therapeutics at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
SBS - Short Bowel Syndrome
What is being tested?
FE203799
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteDenmark
Study dates
2 May 2018to 28 Oct 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females with SBS secondary to surgical resection of the small intestine, with or without an intact colon.
  • 18-80 years of age
  • 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)

Who cannot join

  • 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.
Show all 23Show fewer
  • 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
  • Systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or other biologic therapy/immune modifiers within 30 days of screening
  • Any use of growth hormone, glutamine or growth factors such as native GLP-2 or GLP-2 analogue within the last 3 months
  • Any use of antibiotics within the last 30 days
  • Participation in another clinical trial within the last 3 months and during this trial
  • Previously been treated in this trial
  • Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening
  • Patient not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements
  • For any other reason judged not eligible by the investigator

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

Official title: A Phase Ib/IIa Open-label, Repeated Dose, Metabolic Balance Study of FE 203799 in Patients With Short Bowel Syndrome and Intestinal Insufficiency

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.

Read the detailed description

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.

The first two administrations of trial drug will be performed at the clinic, while the third dose can be either self-administered by the patient or administered at the clinic if the patient prefers to travel to the site or other considerations make a site visit preferable. The fourth administration of trial drug will be performed at the clinic just prior to assessment of efficacy parameters in the treatment balance study.

Prior to each administration of trial drug, liver function parameters will be analysed and assessed. During the entire trial, patients who develop extremely high or persistently elevated liver enzymes following trial drug administration will be discontinued from the trial.

The patients will complete a diary with data on trial drug administration performed at home, local tolerability and adverse events (AEs).

Being tested
FE203799
Medical subject headings
Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FE203799Drug

    Also called GLP 2 analogue

    FE203799 5 mg subcutaneous once weekly

Study groups in NCT03408132
Study groupRoleWhat they receive
FE203799 5 mgExperimentalFE203799 5 mg subcutaneous injection
Receives: Drug: FE203799

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events

    Adverse events as assessed by CTCAE v4.03

    Measured: Day -28 to Day 26 plus 6 weeks

Secondary outcomes (13)

  1. Assessment of intestinal insufficiency and gut absorption

    Changes in the wet weight (g) of faecal excretion

    Measured: Day -28 to day 26

  2. Assessment of intestinal insufficiency and gut absorption

    Changes from baseline in lean body mass by DEXA scan.

    Measured: Day -28 and day 26

  3. Assessment of intestinal insufficiency and gut absorption

    Changes from baseline in bone mineral content by DEXA scan.

    Measured: Day -28 and day 26

  4. Assessment of intestinal insufficiency and gut absorption

    Changes from baseline in fat mass by DEXA scan.

    Measured: Day -28 and day 26

  5. Assessment of intestinal insufficiency and gut absorption

    Measure of body weight (kg)

    Measured: Day -28 to day 26 plus 6 weeks

  6. Assessment of intestinal insufficiency and gut absorption

    Measurement of urinary output (ml)

    Measured: Baseline (Day -6) to end of treatment (Day 26)

  7. Assessment of intestinal insufficiency and gut absorption

    Measurement of urinary electrolytes (sodium, potassium, calcium, magnesium) (mmol/d)

    Measured: Baseline (Day -6) to end of treatment (Day 26)

  8. Assessment of gut regeneration

    Measurements of the plasma Citrulline (ng/ml)

    Measured: Baseline (Day -7) to end of treatment period (Day 26) plus 6 weeks

  9. Maximum observed plasma concentration (Cmax)

    Cmax (ng/ml)

    Measured: Day 1 to end of treatment period (Day 26)

  10. Cumulative area under the plasma concentration (AUC) of FE 203799 from time 0 to 168

    AUC0-168 (ng*hr/ml)

    Measured: Day 1 to end of treatment period (Day 26)

  11. Terminal elimination half-life (T1/2) of FE 203799

    T1/2 (h)

    Measured: Day 1 to end of treatment period (Day 26)

  12. Apparent total body clearance (CL) of FE 203799 from plasma

    CL (ml/hr)

    Measured: Day 1 to end of treatment period (Day 26)

  13. Apparent volume of distribution (Vd) of FE 203799 during terminal phase

    Vd (ml)

    Measured: Day 1 to end of treatment period (Day 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start2 May 2018
  3. Primary completion28 Oct 2019
  4. Study completion28 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03408132
Sponsor's protocol ID
GLY-321-2017
Status last verified
Feb 2020
First submitted
21 Nov 2017
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FE203799 in people with SBS - Short Bowel Syndrome, run by GlyPharma Therapeutics at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: Day -28 to Day 26 plus 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03408132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

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