Association between exposure to liraglutide versus active comparators and risk of acute hepatic injury

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000243
• EU PAS number:
  EUPAS1000000243
• Study ID:
  1000000243
• Official title and acronym:
  Association between exposure to liraglutide versus active comparators and risk of acute hepatic injury
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  A cohort study which will investigate a potentially increased risk of Diseases of liver and Acute hepatic injury among patients who initiated treatment with liraglutide.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 02/02/2024

Actual: 01/03/2024

Study start date

Planned: 03/05/2024

Actual: 03/06/2024

Date of final study report

Planned: 22/07/2024

Actual: 30/07/2024

Study protocol

Updated protocol

FINAL_Protocol_Liraglutide and acute hepatic injury_v3.1_20240917.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable