A Study of NST-6179 in Adult Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of
NST-6179 in adult subjects with intestinal failure-associated liver disease (IFALD) receiving
parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 adult
subjects diagnosed with IFALD will be enrolled in the study, of which 18 subjects will be
enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or
matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral
administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose
for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined
during the safety review meeting.