A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo. At least 100 patients will be enrolled in a 100 mg open-label arm and will include a special safety population (eg, patients with compensated NASH cirrhosis).

Key facts

Study ID

NCT04197479

Run by

Madrigal Pharmaceuticals, Inc.

People needed

1343

Starts

2019-12-16

Expected to finish

2023-01-06

Last updated by the study team

2023-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be willing to participate in the study and provide written informed consent.
• Male and female adults ≥18 years of age.
• Suspected or confirmed diagnosis of NASH or NAFLD (presumed NASH):
• Fibroscan with kPa ≥5.5 and <8.5; CAP ≥280 dB.m-1 OR
• MRE ≥2 and <4.0; MRI-PDFF ≥8% liver fat consistent with steatosis and fibrosis stage ≥1 and <4. OR
• Recent liver biopsy (within past 2 years) documenting NASH/NAFLD with steatosis showing one of the following:
• NAS ≥4, steatosis ≥1, fibrosis stage 0 or F1A/1C with PRO-C3 <14
• NAS <4, steatosis ≥1, with fibrosis stage ≤3
• NAS ≥4, steatosis ≥1, fibrosis stage ≤3 without ballooning
• NOTE: Since the completion of enrollment of the double-blind arms, patients meeting all other criteria who have a liver biopsy result from MGL-3196-11 with the following may be enrolled in the open-label active treatment arm of MGL-3196-14 (100 mg dose):
• NAS = 3, steatosis 1, ballooning 1, inflammation 1 with F2 or F3
• NAS = 3, ballooning 0 with F2 or F3
• For the compensated NASH cirrhosis arm, eligible patients must have compensated NASH cirrhosis diagnosed by liver biopsy showing NASH with F4 stage fibrosis (either historic or recent biopsy) or a historic biopsy with NASH F2-F3 fibrosis with subsequent progression to NASH cirrhosis as diagnosed by an expert hepatologist/gastroenterologist.
• Compensated NASH cirrhosis at screening and baseline includes
• Child Pugh-A (score 5-6) ( may have either mild hepatic encephalopathy OR mild diuretic responsive ascites OR albumin < 3.5 and ≥ 3.2 (not any two of these, unless explained by Gilbert's Syndrome or non-hepatic causes)).
• MELD < 12 at screening/baseline unless MELD ≥ 12 based on non-cirrhotic parameters (e.g., elevated INR due to anticoagulation, bilirubin elevation due to documented Gilbert's Syndrome, elevated creatine due to renal disease (non-hepatic)).
• Albumin ≥ 3.2.
• Bilirubin < 2 (unless documented Gilbert's Syndrome).
• MRI-PDFF fat fraction ≥8% obtained during the Screening Period (baseline MRI-PDFF) or a historic MRI-PDFF ≤8 weeks old at the time of randomization.
• Stable dyslipidemia therapy for ≥30 days prior to randomization.

You may not qualify if…

• History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
• Regular use of drugs historically associated with NAFLD.
• History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
• Weight gain or loss ≥5% total body weight within 12 weeks prior to randomization.
• HbA1c >9.0%.
• Glucagon-like peptide 1 [GLP-1] agonist therapy or high dose vitamin E (>400 IU/day) unless stable for 24 weeks prior to biopsy.
• Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
• Diagnosis of hepatocellular carcinoma (HCC).
• Model for End-stage Liver Disease (MELD) score ≥12, as determined at Screening, unless due to therapeutic anti coagulation or Gilbert syndrome.
• Hepatic decompensation.
• Chronic liver diseases.
• Has an active autoimmune disease.
• Serum ALT >250 U/L.
• History of biliary diversion.
• Uncontrolled hypertension (either treated or untreated).
• Active, serious medical disease with a likely life expectancy <2 years.
• Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer, prior to randomization.
• Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.

Where it is running

• Arizona Liver Health - Chandler — Chandler, Arizona, United States
• East Valley Family Physicians — Chandler, Arizona, United States
• The Institute For Liver Health - Glendale — Glendale, Arizona, United States
• Arizona - Desert Clinical Research — Mesa, Arizona, United States
• The Institute For Liver Health - Tucson — Tucson, Arizona, United States
• Adobe Gastroenterology — Tucson, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Fresno Clinical Research Center — Fresno, California, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States
• Ruane Clinical Research Group — Los Angeles, California, United States
• National Research Institute - Los Angeles — Los Angeles, California, United States
• Catalina Research Institute — Montclair, California, United States
• National Research Institute - Panorama City — Panorama City, California, United States
• Alliance Clinical Research — Poway, California, United States
• San Fernando Valley Health Institute — West Hills, California, United States
• South Denver Gastroenterology - Swedish Medical Center Office — Englewood, Colorado, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Velocity Clinical Research, Hallandale Beach (MD Clinical) — Hallandale, Florida, United States
• Floridian Clinical Research — Hialeah, Florida, United States
• Nature Coast Clinical Research - Inverness — Inverness, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Miami Dade Medical Research Institute — Miami, Florida, United States
• Orlando Research Center — Orlando, Florida, United States
• Central Research Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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