Actively Recruiting
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)
Led by NorthSea Therapeutics B.V. · Updated on 2025-01-07
36
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 2:1 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.
CONDITIONS
Brief Title
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 16 years or older at the time of informed consent
- Minimum of 6 months on parenteral nutrition
- Established clinical diagnosis of IFALD with persistent elevation of liver enzymes (ALP, AST, ALT, or GGT 21.5 times upper limit of normal) for at least 6 months and/or total bilirubin above upper limit of normal for at least 6 months
- Laboratory results consistent with stable liver disease without cirrhosis: ALT and AST less than 5 times upper limit of normal; total bilirubin 24.5 mg/dL if no Gilbert's Syndrome; serum albumin 2.5 g/dL; INR 1.3 without anticoagulant therapy; platelet count 120,000/mm3
You will not qualify if you...
- Evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver disease
- Clinical signs of compensated or decompensated liver cirrhosis including jaundice, ascites, variceal bleeding, or hepatic encephalopathy
- Presence of hepatic impairment, end-stage liver disease, or MELD score above 12
- Transient elastography reading greater than 20.0 kPA within 3 months prior to or during screening
- Estimated glomerular filtration rate below 45 mL/min
- Poor nutritional status defined as body mass index less than 17 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive once daily oral administration of 800mg NST-6179 or matched placebo for 4 weeks.
Weekly visits for up to 4 weeks
Duration - 12 weeks
Participants receive once daily oral administration of 1200mg NST-6179 or matched placebo for 12 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 13 locations
1
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
3
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
8
Mayo Clinic Rochester Campus
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
10
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
11
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Michelle Yokley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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