VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.
NCT ID: NCT04988997
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2021-06-14
2022-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Vurolenatide 50 mg/PBO
50 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 50mg/PBO
Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 100 mg/PBO
100 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 100mg/PBO
Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 50/50 mg
50 mg weekly SC administration
Vurolenatide 50/50 mg
Vurolenatide - 50 mg weekly SC administration
Placebo
PBO - weekly SC administration
Placebo
PBO - weekly SC administration
Interventions
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Vurolenatide 50mg/PBO
Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 100mg/PBO
Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
Vurolenatide 50/50 mg
Vurolenatide - 50 mg weekly SC administration
Placebo
PBO - weekly SC administration
Eligibility Criteria
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Inclusion Criteria
1. Male and female adults with SBS secondary to surgical resection of small intestine
2. 18-75 years of age at the time of screening.
3. 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.
4. 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.
5. At least 6 months since last surgical bowel resection.
6. Patients may be on Parenteral Support \[PS\] (nutrition and/or fluid and electrolytes for at least some of their nutritional needs).
7. If on PS, stable administration of PS volume for 1 month (±20% vol) prior to enrollment \[stable administration of PS volume confirmed by Medical Monitor\].
8. Able to ingest solid or semi-solid foods and drink.
Exclusion Criteria
1. Pregnancy or lactation
2. Body mass index at screening \<18 or \>30 kg/m2
3. Clinically significant intestinal adhesions and/or chronic abdominal pain that can interfere with the conduct of the study
4. 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
5. Inflammatory bowel disease patients who have NOT been on a stable drug treatment regimen for at least the past 3 months prior to screening
6. Visible blood in the stool within the last 3 months
7. Known heart failure or active coronary disease
8. Alcohol or drug abuse within the last 12 months by history, or a disqualifying positive urine drug test at screening.
9. 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.
10. Personal or family history of medullary thyroid cancer.
11. History of pancreatitis
12. Any use of growth hormone, or growth factors such as native GLP-2 or GLP-2 analog (teduglutide) within the last 3 months
13. Use of antibiotics within the last 30 days
14. Patient not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
18 Years
75 Years
ALL
No
Sponsors
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9 Meters Biopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Gainesville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Boston, Massachusetts, United States
Research Site
Omaha, Nebraska, United States
Research Site
Durham, North Carolina, United States
Research Site
Nashville, Tennessee, United States
Countries
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Other Identifiers
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NMSBS01-002
Identifier Type: -
Identifier Source: org_study_id