πŸ›οΈ Verified NIH Record β€’ Updated 2026-04-14

Rezdiffra Pregnancy and Lactation Registry (NCT07541469)

A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRAβ„’ (Resmetirom) During Pregnancy and/or Lactation

🟒 Recruiting Interventional Protocol πŸ“Š Observational Clinical Research Sponsor: Madrigal Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation.

Who can join: Review the eligibility criteria below.

Location: Madrigal Pharmaceuticals β€” West Conshohocken, Pennsylvania

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Madrigal Pharmaceuticals β€” West Conshohocken, Pennsylvania

πŸ“ž Contact the Study Coordinator

Phone: (800) 905-0324

Email: MHGSafety@iconplc.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—