Short Bowel SyndromePhase 2glepaglutideNCT02690025
A Phase 2 Trial Testing ZP1848 in Patients With SBS
A Phase 2 study testing ZP1848 in people with Short Bowel Syndrome, run by Zealand Pharma at 1 site in Denmark.
Trial summary
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- ZP1848
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to May 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
- Age ≥ 18 years and ≤ 90 years
- Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago
- A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS
- Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study.
- Stable body weight (<5% weight deviance in the three months prior to screening)
Who cannot join
- Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator
- Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator.
- Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization
- Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
- History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded)
- eGFR (by the MDRD formula) <30 mL/min/1.73 m2
- Clinically meaningful renal disease as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
- Conditions
- Short Bowel Syndrome
- Being tested
- ZP1848
- 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.
ZP1848Drug
| Study group | Role | What they receive |
|---|---|---|
| ZP1848 High dose | Experimental | s.c. administration of high dose Receives: Drug: ZP1848 |
| ZP1848 Medium dose | Experimental | s.c. administration of medium dose Receives: Drug: ZP1848 |
| ZP1848 Low dose | Experimental | s.c. administration of low dose Receives: Drug: ZP1848 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.
Measured: 3 weeks
Secondary outcomes (14)
Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods
Measured: 3 weeks
Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
Measured: 3 weeks
Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
Measured: 3 weeks
Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods
Measured: 3 weeks
Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods
Measured: 3 weeks
Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods
Measured: 3 weeks
Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods
Measured: 3 weeks
Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods
Measured: 3 weeks
Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods
Measured: 3 weeks
Change in SF-36 score
Measured: 3 weeks
Incidence of Adverse Events
Measured: 15 weeks
Incidence of Anti Drug Antibodies
Measured: 15 weeks
Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods
Measured: 3 weeks
Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Larix A/S
- Responsible party
- Sponsor
- Investigators
- Gertrud Koefoed Rasmussen, MSc, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690025
- Sponsor's protocol ID
- ZP1848-15073
- Acronym
- glepaglutide
- Status last verified
- Jun 2017
- First submitted
- 12 Feb 2016
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hvistendahl MK, Naimi RM, Hansen SH, Rehfeld JF, Kissow H, Pedersen J, Dragsted LO, Sonne DP, Knop FK, Jeppesen PB. Bile acid-farnesoid X receptor-fibroblast growth factor 19 axis in patients with short bowel syndrome: The randomized, glepaglutide phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):923-935. doi: 10.1002/jpen.2224. Epub 2021 Sep 1.
PubMed 34287979Naimi RM, Hvistendahl M, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Gronbaek H, Moller HJ, Vilstrup H, Steensberg A, Jeppesen PB. Effects of glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, on markers of liver status in patients with short bowel syndrome: findings from a randomised phase 2 trial. EBioMedicine. 2019 Aug;46:444-451. doi: 10.1016/j.ebiom.2019.07.016. Epub 2019 Jul 17.
PubMed 31326433Naimi RM, Hvistendahl M, Enevoldsen LH, Madsen JL, Fuglsang S, Poulsen SS, Kissow H, Pedersen J, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Holst JJ, Hartmann B, Hansen SH, Dragsted LO, Steensberg A, Mouritzen U, Hansen MB, Jeppesen PB. Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2019 May;4(5):354-363. doi: 10.1016/S2468-1253(19)30077-9. Epub 2019 Mar 15.
PubMed 30880176
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial Testing ZP1848 in Patients With SBS
- ClinicalTrials.gov ID
- NCT02690025
- Acronym / sponsor ID
- glepaglutide / ZP1848-15073
- Conditions
- Short Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Larix A/S
- Study start
- Feb 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZP1848 High dose | Experimental | Drug: ZP1848s.c. administration of high dose |
| ZP1848 Medium dose | Experimental | Drug: ZP1848s.c. administration of medium dose |
| ZP1848 Low dose | Experimental | Drug: ZP1848s.c. administration of low dose |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
- Age ≥ 18 years and ≤ 90 years
- Stable SBS patients with intestinal insufficiency or failure, where the last surgical resection of gut tissue was performed at least 1 year ago
- A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to randomization for patients requiring PS
- Wet weight of fecal excretion ≥ 1500 g/day demonstrated during a hospital stay prior to screening or during at least one day of the first baseline balance study.
Key exclusion criteria (7 listed)
- Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator
- Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by conventional means of the Investigator.
- Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization
- Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
- History of cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years (except colon cancer: patients with a history of colon cancer generally have to be excluded)
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 |
|---|---|---|
| ZP1848 | Drug | ZP1848 High dose, ZP1848 Low dose, ZP1848 Medium dose |
Primary outcome
The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods.
Time frame: 3 weeks
14 secondary outcomes
Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods
Time frame: 3 weeks
Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods
Time frame: 3 weeks
Change in SF-36 score
Time frame: 3 weeks
Incidence of Adverse Events
Time frame: 15 weeks
Incidence of Anti Drug Antibodies
Time frame: 15 weeks
Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods
Time frame: 3 weeks
Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods
Time frame: 3 weeks
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 21 Jun 2017.
- Derived from this study: PubMed 34287979Hvistendahl MK, Naimi RM, Hansen SH, Rehfeld JF, Kissow H, Pedersen J, Dragsted LO, Sonne DP, Knop FK, Jeppesen PB. Bile acid-farnesoid X receptor-fibroblast growth factor 19 axis in patients with short bowel syndrome: The randomized, glepaglutide phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):923-935. doi: 10.1002/jpen.2224. Epub 2021 Sep 1.
- Derived from this study: PubMed 31326433Naimi RM, Hvistendahl M, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Gronbaek H, Moller HJ, Vilstrup H, Steensberg A, Jeppesen PB. Effects of glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, on markers of liver status in patients with short bowel syndrome: findings from a randomised phase 2 trial. EBioMedicine. 2019 Aug;46:444-451. doi: 10.1016/j.ebiom.2019.07.016. Epub 2019 Jul 17.
- Derived from this study: PubMed 30880176Naimi RM, Hvistendahl M, Enevoldsen LH, Madsen JL, Fuglsang S, Poulsen SS, Kissow H, Pedersen J, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Holst JJ, Hartmann B, Hansen SH, Dragsted LO, Steensberg A, Mouritzen U, Hansen MB, Jeppesen PB. Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2019 May;4(5):354-363. doi: 10.1016/S2468-1253(19)30077-9. Epub 2019 Mar 15.
- Individual participant dataSharing planned: No
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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.
Gertrud Koefoed Rasmussen, MSc study director
Zealand Pharma A/S
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 ZP1848 in people with Short Bowel Syndrome, run by Zealand Pharma 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 6 inclusion and 7 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 21 Jun 2017. 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 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 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?
The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods. (time frame: 3 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 NCT02690025, which also lists 3 linked publications.
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 21 Jun 2017.