2024-02-15
minor
Study Status, Study Description, Arms and Interventions v11
Primary completion date2022-12-19→2028-01
InterventionsMGL-3196 (Drug), Placebo (Drug)→Liver Biopsy (Procedure), MGL-3196 (Drug), Placebo (Drug)
Study description+59 characters
Primary and secondary endpoint population at Week 52 will be at least 900 patients, more than half fibrosis score 3 (F3), the remainder fibrosis score 2 (F2) and <10% fibrosis score F1B (F1B) based on final liver biopsy baseline fibrosis score.
2023-10-11
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2022-12→confirmed 2022-12-19
Completion date2026-05→2028-01
Enrollment targetestimated 2000→confirmed 1759
Study sites223→246
Eligibility criteria+618 characters
[...] ≥ 18 years of age.
Suspected or confirmed diagnosis of NASH
Metabolic risk factors and AST > 20 U/L
Criteria consistent with liver fibrosis assuggested definedby asthe historical data.
Meet one of the following criteria that is consistent with NASH liver fibrosis:
BiochemicalHistorical biochemical test for fibrosis: ORPRO-C3 >14 ng/mL or ELF ≥9
FibroscanFibroScan testwith ORtransient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
Historical liver biopsy withobtained diagnosis<2 ofyears NASHbefore withexpected fibrosisrandomization showing Stage 1B, 2 or 3 fibrosis with [...] [...]
2022-12-02
minor
Study Identification, Study Status, Study Description, Eligibility v9
Eligibility criteria-514 characters
Prescreening Criteria:
At least 3 metabolic risk factors
No history of significant alcohol consumption
Meet AST and FibroScan requirements OR have a historic liver biopsy < 2 years old demonstrating Fibrosis stage 1B, 2 or 3 with NASH [AST > 17 IU (females) or > 20 IU (males)]
Inclusion Criteria:
Must be willing to participate in the st [...] informed consent.
Male and female adults ≥ 18 years of age.
Female patients of child-bearing potential who agree to use study-required contraceptive measures and have a negative pregnancy test
Males must agree to use one of the study-required contraceptive measu [...] [...]
Study description+185 characters
Primary and secondary endpoint population at Week 52 will be at least 900 patients, more than half F3, the remainder F2 and <10% F1B based on final liver biopsy baseline fibrosis score.
Show 8 earlier versions
2022-11-04
minor
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v8
Primary completion date2021-12→2022-12
Completion date2024-03→2026-05
Eligibility criteria+514 characters
Prescreening Criteria:
At least 3 metabolic risk factors
No history of significant alcohol consumption
Meet AST and FibroScan requirements OR have a historic liver biopsy < 2 years old demonstrating Fibrosis stage 1B, 2 or 3 with NASH [AST > 17 IU (females) or > 20 IU (males)]
Inclusion Criteria:
Must be willing to participate in the st [...] informed consent.
Male and female adults ≥ 18 years of age.
Female patients of child-bearing potential who agree to use study-required contraceptive measures and have a negative pregnancy test
Males must agree to use one of the study-required contraceptive measu [...] [...]
Secondary endpoints2 to 1 entries
Week 52 Key Secondary Objective: To determine the effect of once-daily, oral administration o [...] placebo on the percent change from Baseline at 24 weeks in directly measured low-density lipoprotein cholesterol (LDL-C)
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
Primary endpoints2 entries, revised
Month 54 Primary Objective: Time to experiencing an adjudicated Composite long-termClinical outcomeOutcome eventsevent composed(Final ofPrimary all-cause mortalityEndpoint, cirrhosis,at and54 othermonths)
Week significant52 liver-relatedDual events
Primary Objectives: To evaluatedetermine the effect of MGL-3196 80 mg or 100 mg comparedMGL-3196 tovs matching placebo to achieve NASH resolution on liver histologybiopsy in non-cirrhotic (NASH patientsCRN score) at Week 52 compared with stage 2 or 3 fibrosisBaseline
2021-07-06
minor
Study Status, Contacts/Locations v7
2021-03-01
minor
Study Status, Contacts/Locations v6
2020-12-08
minor
Study Status, Contacts/Locations v5
2020-10-19
minor
Study Status, Contacts/Locations v4
Primary completion date2021-06→2021-12
Study sites82→191
2019-12-09
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2021-06-30→2021-06
Completion date2024-03-31→2024-03
Study sites1→82
Eligibility criteria-35 characters
[...] ors and AST > 20 U/L
Criteria consistent with liver fibrosis as defined as one of the following: fibrosis biomarkers or fibroscan or historical liver biopsy with NASH andstage 2 or 3 fibrosis
Biochemical test for fibrosis OR
Fibroscan test OR
Historical liver biopsy with diagnosis of NASH andwith fibrosis Stage 2 or 3 Fibrosis
MRI-PDFF with increased fat fraction
Biopsy-proven NASH (Ba [...]
Secondary endpointsdetails revised at 2 of 2 entries
Primary endpoints2 entries, revised
Composite long-term outcome events composed of all-cause mortality, cirrhosis, and other significant liver-related clinical outcomesevents
2019-07-15
minor
2 amendments v1-v2
2 re-verifications since 2019-05-08, no change to tracked fields