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

• ClinicalTrials.gov Identifier: NCT04988997
• Recruitment Status: Terminated
• First Posted: August 4, 2021
• Last Update Posted: December 20, 2022
• Sponsor: 9 Meters Biopharma, Inc.
• Information provided by (Responsible Party): 9 Meters Biopharma, Inc.

Study Description

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. 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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 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
• Actual Primary Completion Date: August 5, 2022
• Actual Study Completion Date: August 24, 2022

Arms and Interventions

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

Outcome Measures

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 be 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

Eligibility Criteria

• 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.

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

Contacts and Locations

Locations

United States, Florida

Research Site

Gainesville, Florida, United States, 32610

United States, Georgia

Research Site

Atlanta, Georgia, United States, 30322

United States, Massachusetts

Research Site

Boston, Massachusetts, United States, 02118

United States, Nebraska

Research Site

Omaha, Nebraska, United States, 68198

United States, North Carolina

Research Site

Durham, North Carolina, United States, 27710

United States, Tennessee

Research Site

Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

9 Meters Biopharma, Inc.

More Information

• Responsible Party: 9 Meters Biopharma, Inc.
• ClinicalTrials.gov Identifier: NCT04988997
• Other Study ID Numbers: NMSBS01-002
• First Posted: August 4, 2021
• 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

Additional relevant MeSH terms:

Short Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications