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Promising new pill shrinks liver fat in NASH patients

NCT ID NCT02912260

Disease control Sponsor: Madrigal Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested an oral drug called MGL-3196 in 125 adults with non-alcoholic steatohepatitis (NASH), a fatty liver disease that can lead to scarring and liver failure. The main goal was to see if the drug could reduce liver fat measured by MRI after 12 weeks compared to a placebo. Results showed a significant decrease in liver fat for those taking MGL-3196, suggesting it may help control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MGL-3196 (an oral drug)
What this could lead to
If successful, this could lead to a new treatment option for non-alcoholic steatohepatitis (NASH), a serious liver condition with no approved therapies.
What could go wrong
This is an early phase 2 trial with only 125 participants, so results may not hold up in larger studies. The drug may cause side effects or fail to improve long-term liver health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

125 people

The number who actually took part.

Started

Oct 2016

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria. Participants 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; * Female participants 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 (that is, condoms, diaphragm, nonhormonal intrauterine device \[IUD\], or sexual abstinence \[only if this is in line with the participant's current lifestyle\]) 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 (for example, condoms); or female participants of non-child bearing potential (that is, surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\>12 consecutive months without menses\]); Male participants 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 participants 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 magnetic resonance imaging proton density fat fraction; * Biopsy-proven NASH. Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease activity score (NAS) of ≥4 with a score of 1 or more 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) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels consistent with the screening ALT and AST values. Exclusion Criteria. Participants 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; * Hyperthyroidism; * Participants on thyroid replacement therapy (with exceptions); * Prior or planned (during the study period) bariatric surgery (for example, gastroplasty, roux-en-Y gastric bypass); * Type 1 diabetes; * Uncontrolled Type 2 diabetes defined as Hemoglobin A1c (HbA1c) ≥ 9.5% at screening (participants 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 participant, or interfere with the study outcomes.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non - alcoholic steatohepatitis

Contacts and locations

Locations

  • 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, 90057, 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, 39202, 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, 78233, United States

  • Madrigal Research Site

    San Antonio, Texas, United States

  • Madrigal Research Site

    Charlottesville, Virginia, United States

  • Madrigal Research Site

    Seattle, Washington, United States

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