I8F-MC-B016 Tirzepatide Pregnancy Registry - A Multi-Country Registry-Based Observational Study to Assess Maternal, Fetal, and Infant Outcomes Following Treatment with Tirzepatide for Weight Management During Pregnancy

Study identification

• EU PAS number:
  EUPAS1000000517
• Study ID:
  1000000517
• Official title and acronym:
  I8F-MC-B016 Tirzepatide Pregnancy Registry - A Multi-Country Registry-Based Observational Study to Assess Maternal, Fetal, and Infant Outcomes Following Treatment with Tirzepatide for Weight Management During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom

  United States
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned:29/03/2024

Actual:29/03/2024

Study start date

Planned:30/06/2025

Date of final study report

Planned:30/06/2036

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only