Study of resmetirom (MGL-3196) in patients with Non-Alcoholic Steatohepatitis (NASH) to prevent liver damage and disease progression

3 1

What is this study about?

This study examines the effectiveness of resmetirom (also known as MGL-3196) in treating people with Non-Alcoholic Steatohepatitis (NASH), a serious liver condition where fat buildup leads to inflammation and liver damage. NASH occurs when the liver becomes inflamed due to fat accumulation, which can lead to scarring of liver tissue (known as fibrosis) and potentially progress to more severe liver damage.

The study medication resmetirom is taken as a film-coated tablet by mouth once daily. Participants will receive either resmetirom at doses of 60 mg, 80 mg, or 100 mg, or a placebo. The study aims to determine if resmetirom can help resolve NASH and prevent the progression of liver damage. The treatment period lasts for approximately 54 months, during which participants will have regular check-ups to monitor their liver health.

Throughout the study, doctors will use various methods to assess how well the treatment is working, including examining liver tissue samples and using specialized imaging called MRI-PDFF to measure liver fat content. They will also monitor the levels of various substances in the blood that can indicate liver health and track any changes in LDL cholesterol levels. After the main study period, some participants may have the opportunity to continue treatment in a long-term extension phase.

1 Initial assessment and medication start

After joining the study, you will receive either resmetirom or a placebo (inactive tablet that looks the same)

The medication will be taken once daily by mouth in one of these doses: 60 mg, 80 mg, or 100 mg

You will need to have an MRI scan to measure liver fat content

A liver biopsy (small tissue sample from liver) will be performed to assess your condition

2 Week 24 evaluation

Your blood will be tested to measure LDL cholesterol levels

The medical team will evaluate how your body is responding to the treatment

3 Week 52 evaluation

Another evaluation of your LDL cholesterol will be performed

A second liver biopsy will be done to check if your liver condition has improved

The medical team will look for improvements in liver inflammation and scarring

4 Long-term follow-up to month 54

You will continue taking the study medication

Regular health assessments will monitor your liver condition

A final liver biopsy will be performed at month 54

5 Optional extension phase

If you complete all previous study visits and the month 54 liver biopsy, you may be eligible to continue in an extension phase

The extension phase will help gather additional long-term safety information

Treatment will continue beyond 54 months

Who Can Join the Study?

  • Must be willing to provide written informed consent to participate in the study
  • Must be 18 years or older
  • For women who can become pregnant:
    – Must have a negative pregnancy test
    – Must not be breastfeeding
    – Must use two highly effective birth control methods during the study and for 30 days after
    – Or must be post-menopausal (no periods for 12 months) or permanently sterile
  • For men who are sexually active:
    – Must be sterile, or
    – Practice complete sexual abstinence, or
    – Use condoms during sexual activity
    – Must use birth control during the study and for 30 days after
    – Must not donate sperm for 30 days after the study
  • Must have suspected or confirmed NASH fibrosis shown by one of these:
    – Blood test showing PRO-C3 above 14 ng/mL or ELF score of 9 or higher
    – FibroScan showing liver stiffness of 8.5 kPa or higher
    – Liver biopsy within last 2 years showing appropriate fibrosis stage
  • Must have liver fat content of 8% or higher shown on special MRI scan during screening
  • For long-term extension phase:
    – Must provide new written consent
    – Must have completed all main study visits
    – Must have completed liver biopsy at Month 54

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Previous liver transplant or currently on a waiting list for liver transplant
  • History of cirrhosis (severe scarring of the liver) with complications
  • Current or recent history of significant alcohol consumption (more than 2 drinks per day for women or 3 drinks per day for men)
  • Presence of other types of liver disease, such as:
    • Viral hepatitis B or C
    • Autoimmune hepatitis (when the immune system attacks the liver)
    • Wilson’s disease (inherited copper accumulation disorder)
  • History of heart failure or significant heart problems
  • Uncontrolled high blood pressure (above 160/95 mmHg)
  • Poorly controlled diabetes (blood sugar disorder) with HbA1c above 9.5%
  • Severe kidney disease requiring dialysis
  • Active cancer or cancer treatment within the past 5 years
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Use of medications that could interfere with the study drug
  • History of bariatric surgery (weight loss surgery) within the past 5 years

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Universita Cattolica Del Sacro Cuore Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Az Maria Middelares Gent Gent Belgium
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Hospital Universitario Torrecardenas Almeria Spain
Eugastro GmbH Leipzig Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
University Of Debrecen Debrecen Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital General Universitario De Valencia Valencia Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Synexus Polska Sp. z o.o. Poznan Poland
Centre Hospitalier Universitaire De Nice Nice France
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Berlin Germany
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. Palermo Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
University Childrens Hospital Queen Fabiola Brussels Belgium
Synexus Clinical Research GmbH Frankfurt Germany
Cqvmuvmfo Uhjdmhvurckzrm Sidkribay Woluwe-Saint-Lambert Belgium
Olosjtyaotfgqj Lclh Ggjy Linz Austria
Hilzhdkw Utafxumcruwxw Mxcsbpp Du Vkqbigltvu Santander Spain
Uiumblxuwz Huytwwktc Pugmf Sfbjgdocjee Cwofwyy Fpcm Paris France
Cxcrsq Hlqxxslyvxl Eo Uumgprijpcatv Di Lnfuktl Limoges France
Ajvmyyyuem Pgmevjhy Hruxznqt Dm Pooyz Paris France
Bacjtsif Uxrkcmcssh Hisctozu Cysxnj Besançon France
Cxrs Du Nczsf Vandoeuvre Les Nancy France
Gixnqw Usbjuebvyb Fyncgikap Frankfurt Germany
Uvskjwwkjjelzpmqrzkzf Wehemdmxy Azt Wuerzburg Germany
Uygfzlbnae Op Anbefhg Edegem Belgium
Uzuoekoqtb Dbygb Sdpff Du Rzmm Lc Sjbtztep Rome Italy
Cfjtut Hfnkytojdtu Rzrzpbci Dpzldpjyiwkvab Angers France
Cym Ccgcy Rulnygnsvss Lyon France
Hpcbmfwz Vxmq drdiaxrv Barcelona Spain
Hwgwmjal Ulpxxcjaesumsk Skngrjqijt &cybnfl Hesrllo dh Hudvfdneixl STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.09.2019
Belgium Belgium
Not recruiting
30.09.2019
France France
Not recruiting
30.09.2019
Germany Germany
Not recruiting
30.09.2019
Hungary Hungary
Not recruiting
30.09.2019
Italy Italy
Not recruiting
30.09.2019
Poland Poland
Not recruiting
30.09.2019
Spain Spain
Not recruiting
30.09.2019

Trial locations

Investigated drugs:

MGL-3196 (resmetirom) is a medication being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH), a serious liver condition. It is taken as an oral medication once daily. This drug is designed to help resolve NASH symptoms and prevent the progression of liver damage. It works by targeting liver cells and may help reduce liver fat, inflammation, and scarring (fibrosis).

Placebo is used as a control substance in this study to compare with the active medication. It looks identical to the real medication but contains no active ingredients.

Non-Alcoholic Steatohepatitis (NASH) – A progressive liver condition characterized by fat accumulation in the liver, accompanied by inflammation and cell damage. NASH occurs when excess fat builds up in liver cells, leading to swelling and damage over time. The condition develops in people who drink little to no alcohol but have other risk factors such as obesity or diabetes. The disease can cause scarring of liver tissue (fibrosis) and lead to changes in liver structure. NASH is part of a group of conditions called non-alcoholic fatty liver disease (NAFLD).

Trial ID:
2024-510626-89-00
Protocol code:
MGL-3196-11
Trial Phase:
Therapeutic confirmatory (Phase III)

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