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

NCT04988997 | Terminated Phase 2 FDA Drug

• 1 other identifier: NMSBS01-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess the safety and tolerability of vurolenatide

  10 weeks (including 6 weeks follow up)

• To assess change from Baseline in Quality of Life

  10 weeks (including 6 weeks follow up)

• To assess the change from baseline in Patient Global Impression

  10 weeks (including 6 weeks follow up)

Study Arms (4)

Vurolenatide 50 mg/PBO

ACTIVE COMPARATOR

50 mg biweekly SC administration, PBO alternate weeks

Drug: Vurolenatide 50mg/PBO

Vurolenatide 100 mg/PBO

ACTIVE COMPARATOR

100 mg biweekly SC administration, PBO alternate weeks

Drug: Vurolenatide 100mg/PBO

Vurolenatide 50/50 mg

ACTIVE COMPARATOR

50 mg weekly SC administration

Drug: Vurolenatide 50/50 mg

Placebo

PLACEBO COMPARATOR

PBO - weekly SC administration

Drug: Placebo

Interventions

Vurolenatide 50mg/PBO DRUG

Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks

Vurolenatide 50 mg/PBO

Vurolenatide 100mg/PBO DRUG

Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks

Vurolenatide 100 mg/PBO

Vurolenatide 50/50 mg DRUG

Vurolenatide - 50 mg weekly SC administration

Vurolenatide 50/50 mg

Placebo DRUG

PBO - weekly SC administration

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults with SBS secondary to surgical resection of small intestine
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 9 Meters Biopharma, Inc.: lead

Study Sites (6)

Research Site

Gainesville, Florida, 32610, United States

Location

Research Site

Atlanta, Georgia, 30322, United States

Location

Research Site

Boston, Massachusetts, 02118, United States

Location

Research Site

Omaha, Nebraska, 68198, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind, Double-Dummy, Placebo-Controlled.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, Double-Dummy, Placebo-Controlled.

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 4, 2021
• Study Start: June 14, 2021
• Primary Completion: August 5, 2022
• Study Completion: August 24, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)