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Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT02912260
Recruitment Status : Unknown
Verified December 2017 by Madrigal Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Madrigal Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change in hepatic fat fraction from baseline in patients with biopsy-proven Non-alcoholic Steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: MGL-3196 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-controlled Study of MGL-3196 in Patients With Non-alcoholic Steatohepatitis
Study Start Date : September 2016
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MGL-3196
Study Drug
 Drug: MGL-3196
Placebo Comparator: Placebo
Matching Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Two-point reduction in Non-alcoholic fatty liver disease NASH CRN (NAFLD) activity score (NAS) [ Time Frame: 36 weeks ]
  2. Resolution of Non-alcoholic steatohepatitis (NASH) (ballooning = 0; inflammation = 0 to 1) as determined by the NASH CRN NAS score [ Time Frame: 36 weeks ]
  3. Improvement in fibrosis by at least 1 stage with no worsening of steatohepatitis [ Time Frame: 36 weeks ]
  4. Change from baseline in hepatic fat fraction [ Time Frame: 36 weeks ]
  5. Safety and tolerability of MGL-3196 based on Adverse Events and Changes in Laboratory Values [ Time Frame: 12 and 36 weeks ]
  6. Effect on high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 12 and 36 weeks ]
  7. Effect on serum alanine aminotransferase (ALT) [ Time Frame: 12 and 36 weeks ]
  8. Effect on aspartate aminotransferase (AST) [ Time Frame: 12 and 36 weeks ]
  9. Effect on lipid parameters [ Time Frame: 12 and 36 weeks ]
    Determine the effect on lipid parameters including low-density lipoprotein cholesterol (LDL-C), non- LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, triglycerides, apolipoprotein B (ApoB), and lipoprotein(a) (Lp[a]) particles.

  10. Effect on NASH and fibrosis biomarkers [ Time Frame: 12 and 36 weeks ]
    Determine the effect on NASH and fibrosis biomarkers including cytokeratin-18 (CK-18), fibrosis-4 (FIB-4), and enhanced liver function (ELF) test.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria. Patients who meet all of the following criteria will be eligible to participate in the study:

  • Must be willing to participate in the study and provide written informed consent;
  • 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. Patients who meet any of the following criteria will be excluded from participation in the study:

Note: Unless otherwise specified, repeat testing may be performed in consultation with the Medical Monitor.

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912260


Locations
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United States, Alabama
Madrigal Research Site
Dothan, Alabama, United States
United States, Arizona
Madrigal Research Site
Tucson, Arizona, United States
United States, California
Madrigal Research Site
Coronado, California, United States
Madrigal Research Site
Los Angeles, California, United States, 90057
Madrigal Research Site
Rialto, California, United States
Madrigal Research Site
San Diego, California, United States
Madrigal Research Site
Ventura, California, United States
United States, Colorado
Madrigal Research Site
Englewood, Colorado, United States
United States, Florida
Madrigal Research Site
Boca Raton, Florida, United States
Madrigal Research Site
Lakewood Ranch, 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
United States, Kansas
Madrigal Research Site
Kansas City, Kansas, United States
United States, Louisiana
Madrigal Research Site
Monroe, Louisiana, United States
United States, Maryland
Madrigal Research Site
Baltimore, Maryland, United States
United States, Mississippi
Madrigal Research Site
Jackson, Mississippi, United States, 39202
United States, Missouri
Madrigal Research Site
Saint Louis, Missouri, United States
United States, New Mexico
Madrigal Research Site
Albuquerque, New Mexico, United States
United States, New York
Madrigal Research Site
New York, New York, United States
United States, North Carolina
Madrigal Research Site
Durham, North Carolina, United States
United States, South Dakota
Madrigal Research Site
Rapid City, South Dakota, United States
United States, Texas
Madrigal Research Site
Live Oak, Texas, United States, 78233
Madrigal Research Site
San Antonio, Texas, United States
United States, Virginia
Madrigal Research Site
Charlottesville, Virginia, United States
United States, Washington
Madrigal Research Site
Seattle, Washington, United States
Sponsors and Collaborators
Madrigal Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Madrigal Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02912260    
Other Study ID Numbers: MGL-3196-05
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases