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

9

9 Meters Biopharma

Status and phase

Terminated
Phase 2

Conditions

Short Bowel Syndrome

Treatments

Drug: Vurolenatide 50mg/PBO
Drug: Vurolenatide 100mg/PBO
Drug: Vurolenatide 50/50 mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04988997
NMSBS01-002

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

12 participants in 4 patient groups, including a placebo group

Vurolenatide 50 mg/PBO
Active Comparator group
Description:
50 mg biweekly SC administration, PBO alternate weeks
Treatment:
Drug: Vurolenatide 50mg/PBO
Vurolenatide 100 mg/PBO
Active Comparator group
Description:
100 mg biweekly SC administration, PBO alternate weeks
Treatment:
Drug: Vurolenatide 100mg/PBO
Vurolenatide 50/50 mg
Active Comparator group
Description:
50 mg weekly SC administration
Treatment:
Drug: Vurolenatide 50/50 mg
Placebo
Placebo Comparator group
Description:
PBO - weekly SC administration
Treatment:
Drug: Placebo

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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