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VIBRANT Study of Vurolenatide in Adult Patients With Short Bowel Syndrome.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04988997
Recruitment Status : Recruiting
First Posted : August 4, 2021
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

Brief Summary:
A Study of Vurolenatide in Adult Patients with Short Bowel Syndrome.

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

Detailed Description:
A Phase 2 study of Vurolenatide in adult patients with SBS. A total of 22 patients are 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. Information on patients reported outcomes (ePRO) will be collected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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
Estimated Primary Completion Date : October 29, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Placebo
PBO - weekly SC administration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 evaluated.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Criteria for patient inclusion in this study are as follows:

  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.

Key Exclusion Criteria:

Criteria for exclusion from participation in this study are presented below. If there are any questions as to the inclusion or exclusion of a particular patient, please contact the study Medical Monitor.

  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

Information from the National Library of Medicine

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


Contacts
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Contact: Mary E Layton 919-275-1933 SBS1002@9meters.com

Locations
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United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
9 Meters Biopharma, Inc.
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Responsible Party: 9 Meters Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT04988997    
Other Study ID Numbers: NMSBS01-002
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications