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A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

NCT03551522 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2022-09-15

Study results available
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Summary

A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH)

OLE phase was not analyzed due to the early termination of the study

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

Seladelpar

10 mg, 20 mg, or 50 mg

DRUG

Placebos

Matching placebo Capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-05-08
Completion
2020-08-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551522 on ClinicalTrials.gov