NCT05919680

A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orziloben (NST-6179) in Subjects With Intestinal Failure-Associated Liver Disease (IFALD)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: NorthSea Therapeutics B.V. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 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.

Conditions

• Intestinal Failure Associated Liver Disease

Interventions

Type	Name	Description
DRUG	NST-6179 Part A	Once daily (QD) oral administration of 800mg (32 mL solution) of NST-6179 for 4 weeks
DRUG	NST-6179 Part B	Once daily (QD) oral administration of 1200mg of NST-6179 for 12 weeks
OTHER	Matched Placebo	Matched placebo for administration in Part A or Part B

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-06-26
• Last updated: 2025-01-07

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study