Predicting Long-Term Outcome Risk with Tirzepatide: A Post-Hoc Analysis of SURMOUNT-1

Study identification

• EU PAS number:
  EUPAS49988
• Study ID:
  49989
• Official title and acronym:
  Predicting Long-Term Outcome Risk with Tirzepatide: A Post-Hoc Analysis of SURMOUNT-1
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will evaluate the change in predicted risk for cardiovascular disease and type 2 diabetes between tirzepatide and placebo-treated participants using the SURMOUNT-1 trial data at baseline and 72 weeks. SURMOUNT-1 was a phase 3 trial in adults with overweight or obesity evaluating the impact of tirzepatide versus placebo on weight loss and associated endpoints. The predicted risk will be calculated using validated risk engines.
• Study status:
  Planned

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 16/07/2022

Actual: 27/06/2022

Study start date

Planned: 09/12/2022

Data analysis start date

Planned: 09/12/2022

Date of final study report

Planned: 31/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Pangaea ID 2022-11193