Phase 2a Study of NST-6179 to Evaluate Safety and Effects in Adults With Intestinal Failure-Associated Liver Disease Receiving Parenteral Nutrition

What this Trial Is About

Researchers are evaluating NST-6179 in a phase 2a, multicenter, randomized, double-blind, placebo-controlled study involving adults with intestinal failure-associated liver disease IFALD who receive parenteral nutrition. The study focuses on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of NST-6179, a drug under investigation, with up to 36 participants divided into two sequential parts. In Part A, participants will receive 800 mg of NST-6179 or a matching placebo once daily by mouth for 4 weeks. In Part B, the planned dose is 1200 mg once daily for 12 weeks, though the exact dose will be determined after a safety review. Subjects will be randomized in a 21 ratio to receive either NST-6179 or placebo in both parts of the study. Participants will undergo regular assessments including safety and tolerability evaluations up to 14 weeks, pharmacokinetic measurements on Days 1 and 14, and pharmacodynamic evaluations over 12 weeks focusing on liver fat, inflammation, cholestasis, and fibrosis markers. The study involves laboratory tests and monitoring to track how the drug affects liver function and disease progression throughout the treatment periods.

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