Investigator-Initiated Studies

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

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

Natural History of MASH in Subpopulations of Interest (including pediatrics and patients with compensated cirrhosis)

In scope:

  • Generation of novel data using existing or emerging biomarkers and diagnostics to support patient identification and monitoring
  • Examples include:
    • Point-of-care diagnostics
    • Commercially available blood-based diagnostics
    • Diagnostics that quantify liver function
In scope:

  • African-, Latin-, Asian- and Native American populations
  • Young adults (aged 18-30 years), or elderly adults (aged ≥65 years)
  • Patients pre- or post-bariatric surgery
In scope:

  • Real-world pragmatic studies using guideline-recommended screening algorithms and specialist-referral patterns to demonstrate impact on healthcare resource use and/or patient outcomes
In scope:

  • Trials evaluating lifestyle modifications in conjunction with pharmacotherapy
  • Effects of MASH treatment on metabolic parameters

Out of scope:

  • Independent patient or HCP education programs
  • MASH patient registries or drug registries
  • Other causes of liver steatosis and/or fibrosis
  • Validation of machine-learning or AI tools
  • GWAS analyses

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 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.

Resmetirom is currently only approved in the United States.