Investigator-Initiated Studies

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

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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 proposal is carefully reviewed for its scientific merit to ensure it fits strategically with our areas of research interest. 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

Natural History of MASH (Non-Interventional)

  • With compensated cirrhosis
  • Pediatric MASH

Treatment for MASH

  • Native American populations
  • Asian, African, Latin American or Hispanic populations
  • Pre/post-bariatric surgery
  • Ages 18-30 or over 60

Value and Impact of Treating MASH with Moderate to Advanced Fibrosis*

Emerging or Established Care Pathways*

General Out of Scope

  • 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
(U.S. and Germany Only)

Create an account and begin the IIS concept application process

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IIS Proposal Steps

STEP 1
Ensure alignment with Madrigal’s areas of interest
STEP 2
Develop
your research proposal
STEP 3
Submit proposal
STEP 4
Madrigal team review
STEP 5
If approved, submit full study protocol
STEP 6
Contract and budget finalized
Please note that an IIS application may be rejected at any stage within the review process

IIS Proposal Timing

The application portal will be open year-round for proposal submissions.

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Frequently Asked Questions

What is an IIS?

  • 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

What process should I follow if I already have a fully developed study protocol?

  • Initially, investigators must submit an IIS concept proposal and budget via the online application
  • If Madrigal expresses interest in your proposal, you will be asked to submit a full study protocol

Can proposals that require drug supply be submitted to the portal?

  • Madrigal can provide drug supply for certain approved IIS proposals. If your proposal includes a request for drug supply, please complete the appropriate section of the application