Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT ID: NCT02912260
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
125 participants
INTERVENTIONAL
2016-09-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MGL-3196
Study Drug
MGL-3196
Placebo
Matching Placebo
Placebo
Interventions
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MGL-3196
Placebo
Eligibility Criteria
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Inclusion Criteria
* Male and female adults ≥18 years of age with a BMI \<45 kg/m\^2;
* Female patients of child bearing potential with negative serum pregnancy (beta human chorionic gonadotropin) tests who are not breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control (ie, condoms, diaphragm, non hormonal intrauterine device \[IUD\], or sexual abstinence \[only if this is in line with the patient's current lifestyle\]) throughout the study and for at least 1 month after study completion; hormonal contraception (estrogens stable ≥3 months) and hormonal IUDs are permitted if used with a secondary birth control measure (eg, condoms); OR female patients of non-child bearing potential (ie, surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\>12 consecutive months without menses\]); Male patients who have sexual intercourse with a female partner of child bearing potential from the first dose of study drug until 1 month after study completion must be either surgically sterile (confirmed by documented azoospermia \>90 days after the procedure) OR agree to use a condom with spermicide. All male patients must agree not to donate sperm from the first dose of study drug until 1 month after study completion;
* Must have confirmation of ≥10% liver fat content on PDFF-MRI;
* Biopsy-proven NASH. Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the following NAS components:
* Steatosis (scored 0 to 3),
* Ballooning degeneration (scored 0 to 2), and
* Lobular inflammation (scored 0 to 3);
* Must have documented historical (3 weeks to 6 months prior to the study entry) ALT and AST levels consistent with the screening ALT and AST values.
Exclusion Criteria
* History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening;
* Weight gain or loss \>5% in the 6 months prior to randomization or \>10% in the 12 months prior to screening;
* Hyperthyroidism;
* Patients on thyroid replacement therapy;
* Prior or planned (during the study period) bariatric surgery (eg, gastroplasty, roux-en-Y gastric bypass);
* Type 1 diabetes;
* Uncontrolled Type 2 diabetes defined as Hemoglobin A1c ≥ 9.5% at screening (patients with HbA1c ≥ 9.5% may be rescreened);
* Use of obeticholic acid, ursodeoxycholic acid (Ursodiol® and Urso®), high dose vitamin E (\>400 IU/day) unless on stable dose of vitamin E \>400 IU/day for at least 6 months at the time of liver biopsy, or pioglitazone within 90 days prior to enrollment or since screening biopsy, whichever is longer;
* Presence of cirrhosis on liver biopsy (stage 4 fibrosis);
* Platelet count \< 140,000/mm\^3;
* Clinical evidence of hepatic decompensation;
* Evidence of other forms of chronic liver disease;
* Active, serious medical disease with likely life expectancy \<2 years;
* Participation in an investigational new drug trial in the 30 days prior to randomization; or
* 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.
18 Years
ALL
No
Sponsors
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Madrigal Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Madrigal Research Site
Dothan, Alabama, United States
Madrigal Research Site
Tucson, Arizona, United States
Madrigal Research Site
Coronado, California, United States
Madrigal Research Site
Los Angeles, California, United States
Madrigal Research Site
Rialto, California, United States
Madrigal Research Site
San Diego, California, United States
Madrigal Research Site
Ventura, California, United States
Madrigal Research Site
Englewood, Colorado, United States
Madrigal Research Site
Boca Raton, Florida, United States
Madrigal Research Site
Lakewood Rch, Florida, United States
Madrigal Research Site
Lauderdale Lakes, Florida, United States
Madrigal Research Site
Miami, Florida, United States
Madrigal Research Site
New Port Richey, Florida, United States
Madrigal Research Site
Kansas City, Kansas, United States
Madrigal Research Site
Monroe, Louisiana, United States
Madrigal Research Site
Baltimore, Maryland, United States
Madrigal Research Site
Jackson, Mississippi, United States
Madrigal Research Site
St Louis, Missouri, United States
Madrigal Research Site
Albuquerque, New Mexico, United States
Madrigal Research Site
New York, New York, United States
Madrigal Research Site
Durham, North Carolina, United States
Madrigal Research Site
Rapid City, South Dakota, United States
Madrigal Research Site
Live Oak, Texas, United States
Madrigal Research Site
San Antonio, Texas, United States
Madrigal Research Site
Charlottesville, Virginia, United States
Madrigal Research Site
Seattle, Washington, United States
Countries
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References
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Harrison SA, Ratziu V, Anstee QM, Noureddin M, Sanyal AJ, Schattenberg JM, Bedossa P, Bashir MR, Schneider D, Taub R, Bansal M, Kowdley KV, Younossi ZM, Loomba R. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024 Jan;59(1):51-63. doi: 10.1111/apt.17734. Epub 2023 Oct 2.
Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1354-1361.e7. doi: 10.1016/j.cgh.2021.07.039. Epub 2021 Jul 27.
Harrison SA, Bashir M, Moussa SE, McCarty K, Pablo Frias J, Taub R, Alkhouri N. Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 2021 Jan 4;5(4):573-588. doi: 10.1002/hep4.1657. eCollection 2021 Apr.
Harrison SA, Bashir MR, Guy CD, Zhou R, Moylan CA, Frias JP, Alkhouri N, Bansal MB, Baum S, Neuschwander-Tetri BA, Taub R, Moussa SE. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 30;394(10213):2012-2024. doi: 10.1016/S0140-6736(19)32517-6. Epub 2019 Nov 11.
Other Identifiers
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MGL-3196-05
Identifier Type: -
Identifier Source: org_study_id