Different Doses of ZED1227 vs. Placebo in NAFLD (NormaliZED)

Dr. Falk Pharma

Status and phase: Completed; Phase 2

Conditions: Liver Fibrosis; NAFLD

Treatments: Drug: Placebo; Drug: ZED1227

Study type: Interventional

Funder types: Industry

Identifiers

NCT05305599

CEC-11/NAS

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

186 participants in 4 patient groups, including a placebo group

ZED1227 (low dose) 10 mg

Experimental group

Treatment:

Drug: ZED1227

ZED1227 (middle dose) 25 mg

Experimental group

Treatment:

Drug: ZED1227

ZED1227 (high dose) 50 mg

Experimental group

Treatment:

Drug: ZED1227

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo