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.

At this time, Madrigal can only support investigator-initiated study requests from the United States and Germany.

IIS Areas of Interest

  • With compensated cirrhosis
  • Pediatric MASH
  • Native American populations
  • Asian, African, Latin American or Hispanic populations
  • Pre/post-bariatric surgery
  • Ages 18-30 or over 60
  • MASH patient registries or drug registries
  • Other causes of liver steatosis and/or fibrosis
  • Validation of machine-learning or AI tools
  • Genome-Wide Association Study (GWAS)

*Proposals for these areas of interest will be considered for countries in EU where resmetirom is approved

Submit an IIS Concept Proposal
(US and Germany Applications are currently accepted)

Create an account and begin the IIS proposal application process

IIS Proposal Application

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 and budget to the application.
  • For budgets, no pass-through costs for congress registration, travel, lodging, meals will be considered.
  • Please click here to create your account and submit your proposal and budget.
    If Madrigal expresses interest in your proposal, you will be asked to submit a full study protocol.

  • Madrigal can provide resmetirom drug supply for approved IIS proposals. If your proposal includes a request for drug supply, please note in your application.