VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.
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|ClinicalTrials.gov Identifier: NCT04988997|
Recruitment Status : Terminated (Trial terminated by Sponsor)
First Posted : August 4, 2021
Last Update Posted : December 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Drug: Vurolenatide 50mg/PBO Drug: Vurolenatide 100mg/PBO Drug: Vurolenatide 50/50 mg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Double-Blind, Double-Dummy, Placebo-Controlled.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double-Blind, Double-Dummy, Placebo-Controlled.|
|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|
|Actual Study Start Date :||June 14, 2021|
|Actual Primary Completion Date :||August 5, 2022|
|Actual Study Completion Date :||August 24, 2022|
Active Comparator: Vurolenatide 50 mg/PBO
50 mg biweekly SC administration, PBO alternate weeks
Drug: Vurolenatide 50mg/PBO
Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
Active Comparator: Vurolenatide 100 mg/PBO
100 mg biweekly SC administration, PBO alternate weeks
Drug: Vurolenatide 100mg/PBO
Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
Active Comparator: Vurolenatide 50/50 mg
50 mg weekly SC administration
Drug: Vurolenatide 50/50 mg
Vurolenatide - 50 mg weekly SC administration
Placebo Comparator: Placebo
PBO - weekly SC administration
PBO - weekly SC administration
- 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.
- Assess the safety and tolerability of vurolenatide [ Time Frame: 10 weeks (including 6 weeks follow up) ]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.
- To assess change from Baseline in Quality of Life [ Time Frame: 10 weeks (including 6 weeks follow up) ]Change from baseline in Quality of Life as measured by the SF-36 instrument over the double-blind treatment period
- To assess the change from baseline in Patient Global Impression [ Time Frame: 10 weeks (including 6 weeks follow up) ]Change from baseline in patient reported global SBS improvement over the double-blind treatment period
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
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.
- 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.
Key Exclusion Criteria:
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04988997
|United States, Florida|
|Gainesville, Florida, United States, 32610|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68198|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|Responsible Party:||9 Meters Biopharma, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 4, 2021 Key Record Dates|
|Last Update Posted:||December 20, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Short Bowel Syndrome
Digestive System Diseases