Short Bowel SyndromePhase 1/2NCT03415594
Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support
A Phase 1/2 study testing FE203799 GLP-2 analogue in people with Short Bowel Syndrome, run by GlyPharma Therapeutics at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- FE203799 GLP-2 analogue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 8 May 2018to 21 Nov 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 small intestine
- 18-80 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)
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. Gallstones with subsequent cholecystectomy to resolve the issues is acceptable
Show all 24Show fewer
- 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
- 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 glucagon-like peptide 2 (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 randomised 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.
About this study
Official title: A Once-weekly, Repeated Dose, Placebo Controlled, Double Blind, Randomised Cross-over Trial Investigating Safety, Efficacy and Pharmacodynamics of FE 203799 in Patients With Short Bowel Syndrome With Intestinal Failure Requiring Parenteral Support Followed by an Additional Treatment Period in an Open Label Regimen.
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.
Read the detailed description
This trial is divided into 2 parts. Part A of this trial is a repeated dose, placebo controlled, double blind, randomised cross-over trial investigating safety, efficacy and PD of FE 203799 in 8-10 patients with SBS. Additionally, the plasma concentration of FE 203799 will be assessed for determination of the trough and post-dose concentration in SBS patients. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 or placebo once weekly for 4 consecutive weeks, and after a washout period of 6-10 weeks, the alternate treatment will be administered once weekly for 4 consecutive weeks. Safety follow-up assessments will be performed 6-10 weeks after the last dose in each treatment period.
Part B of this trial, treatment period 3, is an open label extension to part A that will test a new dose. Following a washout period of 6-10 weeks after the last dose in treatment period 2, the new dose will be administered once weekly for 4 weeks. Safety follow-up assessments will be performed 4-6 weeks after the last dose in treatment period 3.
The first two administrations of trial drug in each treatment period will be performed at the clinic, while the third and fourth 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.
Prior to each administration of trial drug, liver function parameters will be analysed and assessed. During each treatment period, 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 during each treatment period with daily data on parenteral support (PS) usage, oral liquid intake at specific periods, trial drug administrations performed at home, local tolerability and adverse events (AEs).
- Conditions
- Short Bowel Syndrome
- Being tested
- FE203799 GLP-2 analogue, FE203799 Placebo GLP-2 analogue
- 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.
FE203799 GLP-2 analogueDrug
FE203799 5 mg subQ once weekly
FE203799 Placebo GLP-2 analogueDrug
Placebo subQ once weekly
FE203799 GLP-2 analogueDrug
FE203799 10 mg subQ once weekly
| Study group | Role | What they receive |
|---|---|---|
| FE203799 5 mg | Experimental | FE203799 GLP-2 analogue, once weekly, subcutaneous administration Receives: Drug: FE203799 GLP-2 analogue |
| Placebo | Placebo comparator | Placebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration Receives: Drug: FE203799 Placebo GLP-2 analogue |
| FE203799 10 mg | Other | FE203799 GLP-2 analogue, once weekly, subcutaneous administration Receives: Drug: FE203799 GLP-2 analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Adverse events (AEs) as assessed by CTCAE v4.03
Measured: Day -28 to Day 29
Secondary outcomes (10)
Assessment of intestinal failure and gut absorption
Measurement of urinary output (ml)
Measured: Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Measurement of urinary sodium (mmol/d)
Measured: Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Measurement of Parenteral Support (L)
Measured: Day -3 - Day 29
Assessment of intestinal failure and gut absorption
Measurement of oral fluids intake (L)
Measured: Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Changes from baseline in lean body mass by DEXA scan
Measured: Day -3 and Day 29
Assessment of intestinal failure and gut absorption
Changes from baseline in fat mass by DEXA scan
Measured: Day -3 and Day 29
Assessment of intestinal failure and gut absorption
Changes from baseline in bone mineral content by DEXA scan
Measured: Day -3 and Day 29
Assessment of gut regeneration
Measurements of the plasma citrulline (ng/ml)
Measured: Day 1 - Day 29
Plasma Trough concentration (Ctrough) of study drug
Ctrough
Measured: Day 1 - Day 29
Plasma concentration post 72 hours (C72) of study drug
C72
Measured: Day 1 - Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start8 May 2018
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlyPharma Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VectivBio AG
- Responsible party
- Sponsor
- Investigators
- Tomasz Masior, Study director, VectivBio AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415594
- Sponsor's protocol ID
- GLY-311-2017
- Status last verified
- Feb 2020
- First submitted
- 16 Nov 2017
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34287970
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Once-weekly, Repeated Dose, Placebo Controlled, Double Blind, Randomised Cross-over Trial Investigating Safety, Efficacy and Pharmacodynamics of FE 203799 in Patients With Short Bowel Syndrome With Intestinal Failure Requiring Parenteral Support Followed by an Additional Treatment Period in an Open Label Regimen.
- ClinicalTrials.gov ID
- NCT03415594
- Acronym / sponsor ID
- GLY-311-2017
- Conditions
- Short Bowel Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- GlyPharma TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- VectivBio AG
- Study start
- 8 May 2018 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is divided into 2 parts. Part A of this trial is a repeated dose, placebo controlled, double blind, randomised cross-over trial investigating safety, efficacy and PD of FE 203799 in 8-10 patients with SBS. Additionally, the plasma concentration of FE 203799 will be assessed for determination of the trough and post-dose concentration in SBS patients. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 or placebo once weekly for 4 consecutive weeks, and after a washout period of 6-10 weeks, the alternate treatment will be administered once weekly for 4 consecutive weeks. Safety follow-up assessments will be performed 6-10 weeks after the last dose in each treatment period.
Part B of this trial, treatment period 3, is an open label extension to part A that will test a new dose. Following a washout period of 6-10 weeks after the last dose in treatment period 2, the new dose will be administered once weekly for 4 weeks. Safety follow-up assessments will be performed 4-6 weeks after the last dose in treatment period 3.
The first two administrations of trial drug in each treatment period will be performed at the clinic, while the third and fourth 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.
Prior to each administration of trial drug, liver function parameters will be analysed and assessed. During each treatment period, 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 during each treatment period with daily data on parenteral support (PS) usage, oral liquid intake at specific periods, trial drug administrations performed at home, local tolerability and adverse events (AEs).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FE203799 5 mg | Experimental | Drug: FE203799 GLP-2 analogueFE203799 GLP-2 analogue, once weekly, subcutaneous administration |
| Placebo | Placebo comparator | Drug: FE203799 Placebo GLP-2 analoguePlacebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration |
| FE203799 10 mg | Other | Drug: FE203799 GLP-2 analogueFE203799 GLP-2 analogue, once weekly, subcutaneous administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females with SBS secondary to surgical resection of small intestine
- 18-80 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FE203799 GLP-2 analogueFE203799 5 mg subQ once weekly | Drug | FE203799 5 mg |
| FE203799 Placebo GLP-2 analoguePlacebo subQ once weekly | Drug | Placebo |
| FE203799 GLP-2 analogueFE203799 10 mg subQ once weekly | Drug | FE203799 10 mg |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: Day -28 to Day 29
Adverse events (AEs) as assessed by CTCAE v4.03
10 secondary outcomes
Assessment of intestinal failure and gut absorption
Time frame: Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Time frame: Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Time frame: Day -3 - Day 29
Assessment of intestinal failure and gut absorption
Time frame: Day -3 - Day 28
Assessment of intestinal failure and gut absorption
Time frame: Day -3 and Day 29
Assessment of intestinal failure and gut absorption
Time frame: Day -3 and Day 29
Assessment of intestinal failure and gut absorption
Time frame: Day -3 and Day 29
Assessment of gut regeneration
Time frame: Day 1 - Day 29
Plasma Trough concentration (Ctrough) of study drug
Time frame: Day 1 - Day 29
Plasma concentration post 72 hours (C72) of study drug
Time frame: Day 1 - Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 34287970Eliasson 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.
- Individual participant dataSharing planned: No
Related trials for Short Bowel Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Masior study director
VectivBio AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FE203799 GLP-2 analogue in people with 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 24 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 26 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. Some participants in this study may receive a placebo. 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 29). 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 NCT03415594, which also lists 1 linked publication.
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 26 Oct 2024.