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Kansas City Research Institute | Kansas City, MO

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A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis (MAESTRO-NASH)

Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals

Status and phase

Active, not recruiting
Phase 3

Conditions

NASH - Nonalcoholic Steatohepatitis

Treatments

Drug: Placebo
Drug: MGL-3196
Procedure: Liver Biopsy

Study type

Interventional

Funder types

Industry

Identifiers

NCT03900429
MGL-3196-11

Details and patient eligibility

About

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

Full description

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.

Enrollment

1,759 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 NASH liver fibrosis:

    1. Historical biochemical test for fibrosis: PRO-C3 >14 ng/mL or ELF ≥9
    2. FibroScan with transient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
    3. Historical liver biopsy obtained <2 years before expected randomization showing Stage 1B, 2 or 3 fibrosis with NASH based on existing pathology review, with no significant change in body weight >5% or medication that might affect NAS or fibrosis stage.
  4. MRI-PDFF fat fraction ≥8% obtained during the screening period

  5. Biopsy-proven NASH (baseline liver biopsy) based on a liver biopsy obtained ≤6 months before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A/1C, 1B, 2, or 3 on liver biopsy and NAS of ≥4 with a score of at least 1 in each of the following NAS components:

    1. Steatosis (scored 0 to 3)
    2. Ballooning degeneration (scored 0 to 2)
    3. Lobular inflammation (scored 0 to 3)

Exclusion criteria

  1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.

  2. Regular use of drugs historically associated with NAFLD

  3. Thyroid diseases:

    1. Active hyperthyroidism.
    2. Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
    3. Patients who have had a thyroidectomy and are on replacement thyroxine doses >75 µg per day are allowed.
  4. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.

  5. Recent significant weight gain or loss

  6. HbA1c ≥ 9.0%.

  7. Glucagon-like peptide 1 [GLP-1] agonist, high dose Vitamin E (> 400 IU/day), or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.

  8. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.

  9. Diagnosis of hepatocellular carcinoma (HCC).

  10. MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.

  11. Hepatic decompensation

  12. Chronic liver diseases other than NASH

  13. Active autoimmune disease

  14. Serum ALT > 250 U/L.

  15. Active, serious medical disease with a likely life expectancy < 2 years.

  16. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.

  17. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,759 participants in 3 patient groups, including a placebo group

Matching Placebo
Placebo Comparator group
Description:
Placebo Daily
Treatment:
Procedure: Liver Biopsy
Drug: Placebo
80 mg MGL-3196
Active Comparator group
Description:
80 mg daily
Treatment:
Procedure: Liver Biopsy
Drug: MGL-3196
100 mg MGL-3196
Active Comparator group
Description:
100 mg daily
Treatment:
Procedure: Liver Biopsy
Drug: MGL-3196

Trial contacts and locations

246

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Central trial contact

Kimberly Dorney, RN, MSN

Data sourced from clinicaltrials.gov

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