Association between exposure to GLP-1 receptor agonists and risk of suicide-related and self-harm-related events

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000052
• EU PAS number:
  EUPAS1000000052
• Study ID:
  1000000052
• Official title and acronym:
  Association between exposure to GLP-1 receptor agonists and risk of suicide-related and self-harm-related events
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Cohort study aimed at investigating the association between GLP-1 receptor agonists and increased risk of suicide-related and self-injury-related events.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 15/08/2023

Actual: 15/08/2023

Study start date

Planned: 15/09/2023

Actual: 15/09/2023

Data analysis start date

Planned: 27/09/2023

Actual: 27/09/2023

Date of final study report

Planned: 08/11/2023

Actual: 14/11/2023

Sources of funding

EMA

Study protocol

Updated protocol

FINAL_Protocol - Suicidal ideation and GLP1a

Regulatory

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