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Rezdiffra Pregnancy and Lactation Registry, NCT07541469

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Summary

The NIH has registered an observational study (NCT07541469) on ClinicalTrials.gov titled 'Rezdiffra Pregnancy and Lactation Registry'. The study evaluates pregnancy and clinical outcomes in women with MASH (Metabolic Dysfunction-Associated Steatohepatitis) and their infants after exposure to Rezdiffra at any time during pregnancy and/or lactation. The study is sponsored by a pharmaceutical firm and is listed as observational, generating no new compliance obligations for affected parties.

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What changed

This document adds a new observational registry study (NCT07541469) to ClinicalTrials.gov. The study records Rezdiffra as both the intervention and the focus of a pregnancy/lactation exposure cohort, with no active enrollment criteria or compliance deadlines described in the registration entry.

Affected parties — pharmaceutical companies, clinical investigators, and healthcare providers — should note this registry as a postmarketing safety surveillance mechanism. The study generates no immediate regulatory obligations but may inform future labeling or safety communications for Rezdiffra as data accumulates.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Rezdiffra Pregnancy and Lactation Registry

Observational NCT07541469 Kind: OBSERVATIONAL Apr 21, 2026

Abstract

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.

Conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions: Rezdiffra

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Pharmaceutical companies Clinical investigators Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Postmarketing surveillance Drug safety monitoring Registry study
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Topics
Healthcare Product Safety

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