A Phase 3 interventional study of Placebo and Resmetirom in Non-Alcoholic Fatty Liver Disease, sponsored by Madrigal Pharmaceuticals, Inc.. Completed at 77 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-05.
Sponsored by Madrigal Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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).
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 1,343 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Madrigal Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Suspected or confirmed diagnosis of NASH or NAFLD (presumed NASH):
Recent liver biopsy (within past 2 years) documenting NASH/NAFLD with steatosis showing one of the following:
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):
Compensated NASH cirrhosis at screening and baseline includes
Exclusion Criteria:
100 mg daily
Drug: Resmetirom
Placebo daily
Drug: Placebo
80 mg daily
Drug: Resmetirom
100 mg daily
Drug: Resmetirom
Matching tablets
Tablet
Also known as: MGL-3196
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
Time frame: 52 weeks
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in low density lipoprotein C (LDL-C) from baseline to Week 24
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in low density lipoprotein C (LDL-C) from baseline to Week 24
Time frame: 24 weeks
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in apolipoprotein B (ApoB) from baseline to Week 24
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in apolipoprotein B (ApoB) from baseline to Week 24
Time frame: 24 weeks
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in hepatic fat fraction as determined by MRI-PDFF from baseline to Week 16.
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in hepatic fat fraction as determined by MRI-PDFF from baseline to Week 16.
Time frame: 16 weeks
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in triglycerides (TGs) from baseline to Week 24 in patients with baseline TG > 150 mg/dL.
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in triglycerides (TGs) from baseline to Week 24 in patients with baseline TG \> 150 mg/dL.
Time frame: 24 weeks
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo after 52 weeks on FibroScan controlled attenuation parameter (CAP)
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo after 52 weeks on FibroScan controlled attenuation parameter (CAP)
Time frame: 52 weeks
The change from baseline to Week 52 in FibroScan vibration controlled transient elastography (kPa)
The change from baseline to Week 52 in FibroScan vibration controlled transient elastography (VCTE) (kPa) in patients with baseline kPa \>/=7.2 and a Week 52 or end of treatment FibroScan (VCTE)
Time frame: 52 weeks
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Madrigal Pharmaceuticals, Inc.