Study of safety, pharmacokinetics (PK), and efficacy of various single and combination treatments in patients with non-alcoholic fatty liver disease (NAFLD) who have characteristics of non-alcoholic steatohepatitis (NASH)

Phase 1

• Conditions: non-alcoholic fatty liver disease (NAFLD); MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-000440-10-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-13
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

•Phenotypic diagnosis of NASH based on the presence of all of the
following:
•ALT = 43 IU/L (males) or = 28 IU/L (females) at screening
•BMI = 27 kg/m2 (in participants with a self-identified race other than
Asian) or = 23 kg/m2 (in participants with a self-identified Asian race)
•History of Type 2 diabetes mellitus with HbA1c = 9% at baseline
•ELF Test score = 8.5 and = 10.5 at either screening or baseline
•Liver fat = 8%
•Participants must weigh at least 40 kg (88 lbs.) and no more than 150
kg (330 lbs.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Use of other investigational drugs within 5 half-lives of randomization, or within 3 months, whichever is longer
•Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization.
•Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer.
•History or presence of other concomitant liver diseases
•History or current diagnosis of ECG abnormalities
•Patients with contraindications to MRI imaging
•Current or history of significant alcohol consumption
•Clinical evidence of hepatic decompensation or severe liver impairment
•Women of child bearing potential (unless on highly effective methods of contraception)
•Presence of liver cirrhosis
•For cohort 1, use of OAT3 inhibitors or BRCP inhibitors within 5 half-lives or 7 days of randomization, whichever is longer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified