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

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.

Study Overview

• Status: Terminated
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: Vurolenatide 50mg/PBO; Drug: Vurolenatide 100mg/PBO; Drug: Vurolenatide 50/50 mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr total stool output volume	The primary outcome measure is 24hr total stool output volume over the double-blind treatment period compared to baseline.	10 weeks (including 6 weeks follow up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	10 weeks (including 6 weeks follow up)
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.	10 weeks (including 6 weeks follow up)

Collaborators and Investigators

• Sponsor: 9 Meters Biopharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 24, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: NMSBS01-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No