Liver Fibrosis, NAFLD
Conditions
Brief summary
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.
Interventions
DRUGZED1227
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
DRUGPlacebo
Placebo
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has provided signed informed consent * Is a male or female ≥ 18 and \< 75 years of age * Has diagnosed NAFLD * Has diagnosed significant fibrosis (stages 2 or 3)
Exclusion criteria
* Has a history of significant alcohol consumption (an average of \> 20 g/d in females and \> 30 g/d in males) * Has a history or presence of any other significant concomitant liver diseases * Has diagnosed type 1 diabetes mellitus (T1DM) * Has presence of cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change of PRO-C3 levels | 12 weeks | Relative change (%) of serum levels of PRO-C3 between baseline and the EOT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | from baseline to 16 weeks | Incidence of treatment-emergent adverse events. |
Countries
Germany
Outcome results
None listed