Investigator-Initiated Studies

At Madrigal, we support Investigator-Initiated Studies (IIS) projects that advance medical and scientific knowledge about therapies for nonalcoholic steatohepatitis.

Please note that an IIS may also be known by other names that include and/or encompass the following: Investigator-Initiated Trials (IIT), Investigator-Sponsored Trials (IST), Investigator Sponsored Research (ISR), Physician Initiated Trials (PIT), and External Research Programs (ERP).

We actively support external research initiatives through our IIS program, through which we provide financial support for clinical research projects designed, initiated, and sponsored by independent researchers. These projects should focus on treatment, diagnosis, and outcomes in alignment with Madrigal’s areas of interest, address evidence gaps and unmet needs, and explore potential areas of innovation. Each research project is carefully reviewed for its scientific merit to ensure it fits strategically with our therapeutic goals. These reviews are conducted by global committees composed of Madrigal medical and scientific staff from relevant therapeutic areas.

IIS Areas of Interest

Current areas of interest include the generation of real-world evidence on topics related to MASH, for example:

Use of non-invasive tests
Emerging or established care pathways
Specific sub-populations
Natural history of the disease
Value and impact of treating the disease

*Please note that Madrigal will not provide resmetirom for any IIS

†Sub-populations include; Lean MASH, HIV-linked MASH, Pre-Post bariatric surgery, Age-related MASH (<30 or >65 years old), African Americans

Submit an IIS Proposal Application (US Only)

Create an account and begin the IIS proposal application process

Frequently asked questions

  • An IIS is a research project initiated, designed, and sponsored by independent researchers or academic institutions.
  • Unlike studies led directly by pharmaceutical companies, IIS projects are conducted without the company’s direct involvement.
  • These studies focus on various aspects of treatment, diagnosis, and outcomes related to the company’s products.
  • They are typically supported by the company through financial resources and aim to address evidence gaps and unmet needs and explore new areas of innovation.

  • Initially, investigators must submit an IIS proposal application.
  • Please click here to create your account and submit your proposal.
  • If Madrigal expresses interest in your proposal, you will be asked to submit a full study protocol.

  • Madrigal will not provide resmetirom for any IIS research.

Resmetirom is currently only approved in the United States. The EMA is currently reviewing the Marketing Authorization Application for Resmetirom