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

Dr. Falk Pharma logo

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

Trial contacts and locations

1

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Central trial contact

Judith Czarnecki, PhD

Data sourced from clinicaltrials.gov

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