100 mg MGL-3196 for Non-Alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Alcoholic Fatty Liver Disease (NAFLD)MGL-3196 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether the drug MGL-3196 can help treat NASH and prevent it from progressing to more serious liver diseases.

Eligible Conditions
  • Non-Alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: up to 54 months

24 weeks
LDL Cholesterol Lipoproteins
52 weeks
Week 52 Dual Primary Objectives: To determine the effect of 80 or 100 mg MGL-3196 vs matching placebo on liver biopsy (NASH CRN score) at Week 52 compared with Baseline
Week 24
To determine the effect of once-daily, oral administration of MGL-3196 80 or 100 mg versus matching placebo on the percent change from Baseline at 24 weeks in low-density lipoprotein cholesterol (LDL-C)
Week 52
To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with Stage 1 fibrosis
To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve improvement in fibrosis on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Month 54
Composite long-term outcome events composed of all-cause mortality, cirrhosis, and other significant liver-related events
up to 54 months
Month 54 Primary Objective: Time to experiencing an adjudicated Composite Clinical Outcome event (Final Primary Endpoint, at 54 months)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

100 mg MGL-3196
1 of 3
80 mg MGL-3196
1 of 3
Matching Placebo
1 of 3

Active Control

Non-Treatment Group

2000 Total Participants · 3 Treatment Groups

Primary Treatment: 100 mg MGL-3196 · Has Placebo Group · Phase 3

100 mg MGL-3196
Drug
ActiveComparator Group · 1 Intervention: MGL-3196 · Intervention Types: Drug
Matching Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
80 mg MGL-3196
Drug
ActiveComparator Group · 1 Intervention: MGL-3196 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 54 months

Who is running the clinical trial?

Madrigal Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
3,650 Total Patients Enrolled
Rebecca Taub, MDStudy DirectorMadrigal Pharmaceuticals, Inc.
8 Previous Clinical Trials
2,929 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be willing to participate in the study and provide written informed consent.
You are a male or female adult ≥ 18 years of age.
You have a suspected or confirmed diagnosis of NASH.
Patient has metabolic risk factors and AST > 20 U/L.
You have no steatosis.
You have lobular inflammation (scored 0 to 3).

Who else is applying?

What state do they live in?
Tennessee25.0%
Missouri25.0%
California25.0%
Other25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Ruane Clinical Research33.3%
Miami Dade Medical Research Institute33.3%
Saint Louis University33.3%
What portion of applicants met pre-screening criteria?
Did not meet criteria25.0%
Met criteria75.0%
Why did patients apply to this trial?
  • "releif and money for study"
How many prior treatments have patients received?
3+100.0%

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Ruane Clinical Research: < 24 hours
Typically responds via
Phone Call100.0%