Proof of Concept Study in Patients With Short Bowel Syndrome
Status:
Active, not recruiting
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
This is a Phase I/II. proof of concept, open label, two-dose, dose escalation study of NM-002
in adult patients with SBS who previously responded to exenatide. NM-002 is planned to be
administered twice, at up to 3 different dose levels, in up to 3 cohorts, each consisting of
3-4 patients. Doses will be administered on Days 1 and 15 by subcutaneous injection. Patients
will be monitored for their usage of parenteral supplementation, and will fill out a daily
diary for their symptoms of SBS. Urine output will be measured on a daily basis. Patients
will be followed for 6 weeks after the second dose.