Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Phase 2

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: MGL-3196; Drug: Placebo

• Registration Number: NCT02912260
• Lead Sponsor: Madrigal Pharmaceuticals, Inc.

Brief Summary

The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change in hepatic fat fraction from baseline in patients with biopsy-proven Non-alcoholic Steatohepatitis (NASH).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-23
• Primary Completion: 2017-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2017-12-19
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MGL-3196	MGL-3196	Study Drug
Placebo	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in hepatic fat fraction assessed by MRI-PDFF	12 weeks

Secondary Outcome Measures

Name	Time	Method
Resolution of Non-alcoholic steatohepatitis (NASH) (ballooning = 0; inflammation = 0 to 1) as determined by the NASH CRN NAS score	36 weeks
Improvement in fibrosis by at least 1 stage with no worsening of steatohepatitis	36 weeks
Change from baseline in hepatic fat fraction	36 weeks
Safety and tolerability of MGL-3196 based on Adverse Events and Changes in Laboratory Values	12 and 36 weeks
Effect on high-sensitivity C-reactive protein (hsCRP)	12 and 36 weeks
Effect on serum alanine aminotransferase (ALT)	12 and 36 weeks
Two-point reduction in Non-alcoholic fatty liver disease NASH CRN (NAFLD) activity score (NAS)	36 weeks
Effect on aspartate aminotransferase (AST)	12 and 36 weeks
Effect on lipid parameters	12 and 36 weeks	Determine the effect on lipid parameters including low-density lipoprotein cholesterol (LDL-C), non- LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, triglycerides, apolipoprotein B (ApoB), and lipoprotein(a) (Lp\[a\]) particles.
Effect on NASH and fibrosis biomarkers	12 and 36 weeks	Determine the effect on NASH and fibrosis biomarkers including cytokeratin-18 (CK-18), fibrosis-4 (FIB-4), and enhanced liver function (ELF) test.

Trial Locations

Locations (1)

Madrigal Research Site; 🇺🇸 Seattle, Washington, United States