Study of safety, tolerability, and efficacy of a combination treatment of tropifexor and cenicriviroc in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis

Phase 1

• Conditions: on-alcoholic Steatohepatitis (NASH); MedDRA version: 20.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-004208-24-ES
• Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-30
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Written informed consent must be obtained before any assessment is
performed.

Male and female patients 18 years or older (at the time of the screening
visit). Patients must weigh at least 50 kg (110 lb) and no more than 200
kg (440 lb) to participate in the study.

Adequate liver biopsy sample for evaluation by a central reader.

Presence of NASH as demonstrated by histologic evidence based on liver
biopsy - NASH with fibrosis stage F2/F3, demonstrated on liver biopsy
with evaluation by central reading during the screening period.
Alternatively, a historical biopsy can be used if performed within 6
months prior to screening and evaluated by a central reader, if:

- the patient has been receiving any of the therapies listed in Table 5-4,
the dose must have been stable (since 1 month before the biopsy up to
and including screening)
- the patient's weight has been stable (maximum weight loss of 10%
since biopsy up to and including screening)
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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid
(OCA), LMB763 or any other FXR agonist.

Participated in a clinical trial and treated with any investigational
product being evaluated for the treatment of liver fibrosis or NASH in the
6 months before screening.

Patients taking medications prohibited by the protocol.

Current or history of significant alcohol consumption for a period of more
than 3 consecutive months within 1 year prior to screening (significant
alcohol consumption is defined as more than 20 g/day in females and
more than 30 g/day in males, on average) and/or a score on the
modified AUDIT questionnaire = 8

Uncontrolled diabetes defined as HbA1c = 9% at screening

Patients who are not candidates for liver biopsy

Presence of cirrhosis on liver biopsy or medical history

Study & Design

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