Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGL-3196 · 10 trials · 6 indications
1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR 2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
The Composite Clinical Outcome is composed of all-cause mortality, liver transplant, and significant hepatic events (including hepatic decompensation events \[ascites, encephalopathy, or gastroesophageal variceal hemorrhage\], histological progression to cirrhosis, and a confirmed increase of MELD score from \<12 to ≥15).
LDL-C was determined by ultracentrifugation or direct measure. Least-squares (LS) mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor.
The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo.
Cmax after administration
Tmax after administration
AUC (0-last) after administration
t1/2 after administration
comparison between MGL-3196 capsules and MGL-3196 tablets
Measurement of the total radioactivity collected from blood, urine, and feces
| Arm | Type | Description |
|---|---|---|
| Matching Placebo | PLACEBO_COMPARATOR | Placebo Daily |
| 80 mg MGL-3196 | ACTIVE_COMPARATOR | 80 mg daily |
| 100 mg MGL-3196 | ACTIVE_COMPARATOR | 100 mg daily |
| MGL-3196 | EXPERIMENTAL | Study Drug |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo |
| MGL-3196 100 mg tablet plus Clopidogrel 75 mg tablet | EXPERIMENTAL | - |
| MGL-3196 100 mg tablet plus Pioglitazone 15 mg tablet | EXPERIMENTAL | MGL-3196 administered orally plus Pioglitazone administered orally on 2 separate days |
| 40 mg MGL-3196 Tablet | EXPERIMENTAL | Multiple cohorts (normal, varying hepatic impairment, NASH non-cirrhosis, and NASH cirrhosis) evaluated |
| 60 mg MGL-3196 Tablet | EXPERIMENTAL | Multiple cohorts (normal, varying hepatic impairment, NASH non-cirrhosis, and NASH cirrhosis) evaluated |
| 80 mg MGL-3196 Tablet | EXPERIMENTAL | Multiple cohorts (normal, varying hepatic impairment, NASH non-cirrhosis, and NASH cirrhosis) evaluated |
| 100 mg MGL-3196 Tablet | EXPERIMENTAL | Multiple cohorts (normal, varying hepatic impairment, NASH non-cirrhosis, and NASH cirrhosis) evaluated |
| Capsule then Tablet | ACTIVE_COMPARATOR | MGL-3196 Capsule on Day 1 followed by MGL-3196 Tablet on Day 5 |
| Tablet then Capsule | ACTIVE_COMPARATOR | MGL-3196 Tablet on Day 1 followed by MGL-3196 Capsule on Day 5 |
| Treatment | EXPERIMENTAL | MGL-3196 |
| Name | Type | Description |
|---|---|---|
| MGL-3196 | DRUG | Tablet |
| Placebo | DRUG | Matching Tablets |
| Liver Biopsy | PROCEDURE | A procedure in which a needle is inserted into the liver to collect a tissue sample |
| MGL-3196 (resmetirom) | DRUG | Oral |
| Clopidogrel | DRUG | After one-day washout period after Day 1, loading dose of 300 mg clopidogrel administered on Day 3 and then, at approximately the same time each morning, 75 mg clopidogrel administered on Days 4 to 11 |
| Pioglitazone 15mg | DRUG | Pioglitazone 15 mg tablet administered orally on 2 separate days, initially on one day alone and again after MGL-3196 has been dosed to steady-state |
| MGL-3196 Tablet | DRUG | MGL-3196 in Tablet form |
| MGL-3196 Capsule | DRUG | MGL-3196 in Capsule form |
| Atorvastatin | DRUG | - |
| Simvastatin | DRUG | - |
| Rosuvastatin | DRUG | - |
Inclusion Criteria: 1. Must be willing to participate in the study and provide written informed consent. 2. Male and female adults ≥ 18 years of age. 3. Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NAS...
MGL-3196 is an investigational small molecule being developed by Madrigal Pharmaceuticals for the treatment of non-alcoholic steatohepatitis (NASH), heterozygous familial hypercholesterolemia, and hepatic impairment. It is also known as resmetirom. The drug is currently in clinical development and has not been approved by the FDA.
MGL-3196 is being studied for the treatment of non-alcoholic steatohepatitis (NASH) with fibrosis. A Phase 3 study is evaluating its efficacy and safety in patients with NASH and fibrosis, and a completed Phase 2 study assessed its effects in patients with NASH.
MGL-3196 is developed by Madrigal Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MDGL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several liver-related conditions.
MGL-3196 is in Phase 3 clinical development for NASH with fibrosis, based on an active Phase 3 trial. It has also completed Phase 1 and Phase 2 studies for other indications, including heterozygous familial hypercholesterolemia and hepatic impairment.
MGL-3196 is being evaluated in a Phase 3 trial (NCT03900429) for NASH with fibrosis, which is active but not recruiting. Completed trials include a Phase 2 study in NASH (NCT02912260), a Phase 2 study in heterozygous familial hypercholesterolemia (NCT03038022), and a Phase 1 study in hepatic impairment (NCT04643795).
Yes, MGL-3196 is also known as resmetirom. The Phase 3 trial for NASH and fibrosis uses the name resmetirom in its title, confirming that both names refer to the same investigational drug developed by Madrigal Pharmaceuticals.