Short Bowel SyndromePhase 2NCT04988997
VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.
A Phase 2 study testing Vurolenatide 50mg/PBO, Vurolenatide 100mg/PBO and Vurolenatide 50/50 mg in people with Short Bowel Syndrome, run by 9 Meters Biopharma, Inc. at 6 sites in United States.
Trial summary
A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Vurolenatide 50mg/PBO, Vurolenatide 100mg/PBO and Vurolenatide 50/50 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Jun 2021to 24 Aug 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for patient inclusion in this study are as follows:
- Male and female adults with SBS secondary to surgical resection of small intestine
- 18-75 years of age at the time of screening.
- Female patients must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. If oral contraceptives are used, patients must have been on a stable dose for ≥6 months.
- Male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose. Male patients should not donate sperm for 90 days after last dose.
- At least 6 months since last surgical bowel resection.
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- Patients may be on Parenteral Support [PS] (nutrition and/or fluid and electrolytes for at least some of their nutritional needs).
- If on PS, stable administration of PS volume for 1 month (±20% vol) prior to enrollment [stable administration of PS volume confirmed by Medical Monitor].
- Able to ingest solid or semi-solid foods and drink.
Who cannot join
- Criteria for exclusion from participation in this study are presented below.
- Pregnancy or lactation
- Body mass index at screening <18 or >30 kg/m2
- Clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study
- Active Crohn's disease or IBD (as evaluated by standard procedures employed by the investigator/institution). If in remission, must be ≥12 weeks of remission prior to screening
- Inflammatory bowel disease patients who have NOT been on a stable drug treatment regimen for at least the past 3 months prior to screening
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- Visible blood in the stool within the last 3 months
- Known heart failure or active coronary disease
- Alcohol or drug abuse within the last 12 months by history, or a disqualifying positive urine drug test at screening.
- Inadequate renal function as defined by serum creatinine <0.7 or >1.3 mg/dL (in men) and <0.6 or >1.1 mg/dL in women.
- Personal or family history of medullary thyroid cancer.
- History of pancreatitis
- Any use of growth hormone, or growth factors such as native GLP-2 or GLP-2 analog (teduglutide) within the last 3 months
- Use of antibiotics within the last 30 days
- Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Boston, Massachusetts, 02118
Research Site
Durham, North Carolina, 27710
Research Site
Gainesville, Florida, 32610
Research Site
Nashville, Tennessee, 37212
Research Site
Omaha, Nebraska, 68198
About this study
Official title: A Phase 2, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study of the Efficacy, Safety, and Tolerability of Vurolenatide in Adult Patients With Short Bowel Syndrome
A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome.
Read the detailed description
A Phase 2 study of Vurolenatide in adult patients with SBS. Patients were planned to be dosed in four treatment groups with placebo and/or active Vurolenatide. The study is 13 weeks (3 weeks screening, 4 weeks SC study drug administration, and 6 weeks of follow up). Safety and efficacy will be analyzed.
- Conditions
- Short Bowel Syndrome
- Being tested
- Vurolenatide 50mg/PBO, Vurolenatide 100mg/PBO, Vurolenatide 50/50 mg, Placebo
- 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.
Vurolenatide 50mg/PBODrug
Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 100mg/PBODrug
Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 50/50 mgDrug
Vurolenatide - 50 mg weekly SC administration
PlaceboDrug
PBO - weekly SC administration
| Study group | Role | What they receive |
|---|---|---|
| Vurolenatide 50 mg/PBO | Active comparator | 50 mg biweekly SC administration, PBO alternate weeks Receives: Drug: Vurolenatide 50mg/PBO |
| Vurolenatide 100 mg/PBO | Active comparator | 100 mg biweekly SC administration, PBO alternate weeks Receives: Drug: Vurolenatide 100mg/PBO |
| Vurolenatide 50/50 mg | Active comparator | 50 mg weekly SC administration Receives: Drug: Vurolenatide 50/50 mg |
| Placebo | Placebo comparator | PBO - weekly SC administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr total stool output volume
The primary outcome measure is 24hr total stool output volume over the double-blind treatment period compared to baseline.
Measured: 10 weeks (including 6 weeks follow up)
Secondary outcomes (3)
Assess the safety and tolerability of vurolenatide
Assessment of Adverse events - The frequency of spontaneously reported AEs will be assessed for each treatment group separately by System Organ Class and Preferred Term; and vital signs, physical examination results, clinical laboratory tests results will be evaluated.
Measured: 10 weeks (including 6 weeks follow up)
To assess change from Baseline in Quality of Life
Change from baseline in Quality of Life as measured by the SF-36 instrument over the double-blind treatment period
Measured: 10 weeks (including 6 weeks follow up)
To assess the change from baseline in Patient Global Impression
Change from baseline in patient reported global SBS improvement over the double-blind treatment period
Measured: 10 weeks (including 6 weeks follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start14 Jun 2021
- Primary completion5 Aug 2022
- Study completion24 Aug 2022
Why it stopped: Trial terminated by Sponsor
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.
- 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
- Sequential
- Model description
- Double-Blind, Double-Dummy, Placebo-Controlled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- 9 Meters Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988997
- Sponsor's protocol ID
- NMSBS01-002
- Status last verified
- Dec 2022
- First submitted
- 19 Jul 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study of the Efficacy, Safety, and Tolerability of Vurolenatide in Adult Patients With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04988997
- Acronym / sponsor ID
- NMSBS01-002
- Conditions
- Short Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated by Sponsor
- Enrolment
- 12 participants (actual)
- Lead sponsor
- 9 Meters Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 4 Aug 2021 (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.
A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome.
Detailed description
A Phase 2 study of Vurolenatide in adult patients with SBS. Patients were planned to be dosed in four treatment groups with placebo and/or active Vurolenatide. The study is 13 weeks (3 weeks screening, 4 weeks SC study drug administration, and 6 weeks of follow up). Safety and efficacy will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-Blind, Double-Dummy, Placebo-Controlled.
| Arm | Type | Receives |
|---|---|---|
| Vurolenatide 50 mg/PBO | Active comparator | Drug: Vurolenatide 50mg/PBO50 mg biweekly SC administration, PBO alternate weeks |
| Vurolenatide 100 mg/PBO | Active comparator | Drug: Vurolenatide 100mg/PBO100 mg biweekly SC administration, PBO alternate weeks |
| Vurolenatide 50/50 mg | Active comparator | Drug: Vurolenatide 50/50 mg50 mg weekly SC administration |
| Placebo | Placebo comparator | Drug: PlaceboPBO - weekly SC administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female adults with SBS secondary to surgical resection of small intestine
- 18-75 years of age at the time of screening.
- Female patients must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. If oral contraceptives are used, patients must have been on a stable dose for ≥6 months.
- Male patients must agree to use an acceptable form of birth control during the study and for 30 days after the last dose. Male patients should not donate sperm for 90 days after last dose.
- At least 6 months since last surgical bowel resection.
Key exclusion criteria (15 listed)
- Criteria for exclusion from participation in this study are presented below.
- Pregnancy or lactation
- Body mass index at screening <18 or >30 kg/m2
- Clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study
- Active Crohn's disease or IBD (as evaluated by standard procedures employed by the investigator/institution). If in remission, must be ≥12 weeks of remission prior to screening
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 |
|---|---|---|
| Vurolenatide 50mg/PBOVurolenatide - 50 mg biweekly SC administration, PBO alternate weeks | Drug | Vurolenatide 50 mg/PBO |
| Vurolenatide 100mg/PBOVurolenatide - 100 mg biweekly SC administration, PBO alternate weeks | Drug | Vurolenatide 100 mg/PBO |
| Vurolenatide 50/50 mgVurolenatide - 50 mg weekly SC administration | Drug | Vurolenatide 50/50 mg |
| PlaceboPBO - weekly SC administration | Drug | Placebo |
Primary outcome
24hr total stool output volume
Time frame: 10 weeks (including 6 weeks follow up)
The primary outcome measure is 24hr total stool output volume over the double-blind treatment period compared to baseline.
3 secondary outcomes
Assess the safety and tolerability of vurolenatide
Time frame: 10 weeks (including 6 weeks follow up)
To assess change from Baseline in Quality of Life
Time frame: 10 weeks (including 6 weeks follow up)
To assess the change from baseline in Patient Global Impression
Time frame: 10 weeks (including 6 weeks follow up)
Results and safety
The study was stopped early (reason given: Trial terminated by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vurolenatide 50mg/PBO, Vurolenatide 100mg/PBO and Vurolenatide 50/50 mg in people with Short Bowel Syndrome, run by 9 Meters Biopharma, Inc. at 6 sites in United States.
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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 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 stopped early (reason given: Trial terminated by Sponsor). Results are not available in the source record.
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?
24hr total stool output volume (time frame: 10 weeks (including 6 weeks follow up)). 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 20 Dec 2022.