NCT04988997

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: 9 Meters Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Vurolenatide 50mg/PBO	Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
DRUG	Vurolenatide 100mg/PBO	Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
DRUG	Vurolenatide 50/50 mg	Vurolenatide - 50 mg weekly SC administration
DRUG	Placebo	PBO - weekly SC administration

Timeline

• Start date: 2021-06-14
• Primary completion: 2022-08-05
• Completion: 2022-08-24
• First posted: 2021-08-04
• Last updated: 2022-12-20

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study