Short Bowel SyndromePhase 2SLIPSNCT03371862
Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)
A Phase 2 study testing Liraglutide Pen Injector [Victoza] in people with Short Bowel Syndrome, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in patients with short bowel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Liraglutide Pen Injector [Victoza]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2017to 30 Sep 2020
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Short bowel (≤200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn's disease).
- Jejunostomy patients only
- 12 continuous months of parenteral support (PS) dependency prior to enrolment.
- PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption.
- Stable PS for at least 4 consecutive weeks immediately prior to first dose of liraglutide. Stability is described as:
- Actual PS usage should match prescribed PS;
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- Baseline 48-hour urine output is 1-2 L/24 hours.
- Body mass index ≥ 19.5 kg/m2.
- Adequate hepatic and renal function:
- Total bilirubin within the normal range;
- Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal;
- Serum creatinine ≤1.5x upper limit of normal.
- Stable dosage for > 4 weeks, prior to baseline evaluations, of anti-motility and anti-diarrhoeal agents, H2 antagonists, proton pump inhibitors, bile sequestering agents and oral rehydration solutions.
- Female subjects must be on acceptable method of contraception for a minimum of 4 weeks prior to the start of the trial; Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.
Who cannot join
- Patients < 18 years of age
- Pregnancy (Female subjects who are not surgically sterile or post menopausal (defined as aged 55 years or older and/or at least 2 years have elapsed since the last menses) or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period. Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.
- Active malignancy
- Previous malignancy within the past 5 years
- History of multiple endocrine neoplasia type 2 (MEN 2)
- Personal history or family history of medullary thyroid cancer
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- Raised serum calcitonin (a biomarker for medullary thyroid cancer) at beginning of trial period
- History of cardiac failure
- Concurrent use of diuretics
- Previous history of pancreatitis
- Recent use of other incretin based therapy in the previous 3 months
- Concurrent use of octreotide
- Type 1 or Type 2 diabetes
- Alcohol or drug abuse in last year
- > 4 hospitalisations related to short bowel or its treatment over the previous year
- Any hospitalisation 30 days prior to screening
- Introduction or dose adjustment of immunosuppressant for inflammatory bowel disease within 6 months, or treatment with biologics within the past 6 months (systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, MMF, infliximab, adalimumab, vedolizumab)
- BMI < 19 kg/m2 or > 27kg/m2 (An upper cut-off BMI of > 27kg/m2 has been chosen, as in these patients, there is often a desire to reduce BMI which will conflict with the study design by adding another variable)
- Scleroderma/radiation enteritis/coeliacs disease/refractory or tropical sprue
- Liver and renal function outside the inclusion range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.
Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in patients with short bowel.
- Conditions
- Short Bowel Syndrome
- Being tested
- Liraglutide Pen Injector [Victoza]
- Keywords
- Liraglutide, Victoza
- 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.
Liraglutide Pen Injector [Victoza]Drug
Pilot study of liraglutide in patients with short bowel.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Drug: Liraglutide Pen Injector [Victoza] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in parenteral support
Improvement of parenteral support on 20 weeks of Liraglutide
Measured: 20 weeks post start of drug
Secondary outcomes (4)
Improvement in quality of life
Improvement in Euroqol EQ5-D score. Level 1: indicating no problem, Level 5: indicating extreme problems.
Measured: 20 weeks post start of drug
Duration of response
Duration of response i.e. proportion of subjects who maintain reduction in weekly PN volume from baseline at week 20.
Measured: 20 weeks
Days/Nights not requiring PS
Days/Nights not requiring PS
Measured: 20 weeks
Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations
Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start20 Oct 2017
- Primary completion6 Aug 2020
- Study completion30 Sep 2020 (estimated)
Why it stopped: No participants recruited. Not able to recruit due to COVID 19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siddhartha Oke, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371862
- Sponsor's protocol ID
- 17IC3834
- Acronym
- SLIPS
- Status last verified
- Aug 2020
- First submitted
- 25 Oct 2017
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.
- ClinicalTrials.gov ID
- NCT03371862
- Acronym / sponsor ID
- SLIPS / 17IC3834
- Conditions
- Short Bowel Syndrome
- Keywords
- Liraglutide, Victoza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants recruited. Not able to recruit due to COVID 19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 13 Dec 2017 (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.
Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in patients with short bowel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Liraglutide Pen Injector [Victoza] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Short bowel (≤200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn's disease).
- Jejunostomy patients only
- 12 continuous months of parenteral support (PS) dependency prior to enrolment.
- PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption.
- Stable PS for at least 4 consecutive weeks immediately prior to first dose of liraglutide. Stability is described as:
Key exclusion criteria (20 listed)
- Patients < 18 years of age
- Pregnancy (Female subjects who are not surgically sterile or post menopausal (defined as aged 55 years or older and/or at least 2 years have elapsed since the last menses) or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period. Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.
- Active malignancy
- Previous malignancy within the past 5 years
- History of multiple endocrine neoplasia type 2 (MEN 2)
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 |
|---|---|---|
| Liraglutide Pen Injector [Victoza]Pilot study of liraglutide in patients with short bowel. | Drug | Test group |
Primary outcome
Improvement in parenteral support
Time frame: 20 weeks post start of drug
Improvement of parenteral support on 20 weeks of Liraglutide
4 secondary outcomes
Improvement in quality of life
Time frame: 20 weeks post start of drug
Duration of response
Time frame: 20 weeks
Days/Nights not requiring PS
Time frame: 20 weeks
Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations
Time frame: 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Siddhartha Oke principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide Pen Injector [Victoza] in people with Short Bowel Syndrome, run by Imperial College London at 1 site in United Kingdom.
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 14 inclusion and 20 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: withdrawn, as of the sponsor's last update on 14 Aug 2020. 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 United Kingdom. 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement in parenteral support (time frame: 20 weeks post start of drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020.