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

Short Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04988997
• Other study ID #: NMSBS01-002
• Status: Terminated
• Phase: Phase 2
• Start date: June 14, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: December 2022
• Source: 9 Meters Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 24, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Boston	Massachusetts
United States	Research Site	Durham	North Carolina
United States	Research Site	Gainesville	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
9 Meters Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)