Risk of 4 obesity-related cancers after GLP-1 receptor agonist use

Study identification

• EU PAS number:
  EUPAS1000000990
• Study ID:
  1000000990
• Official title and acronym:
  Risk of 4 obesity-related cancers after GLP-1 receptor agonist use
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The GLP-1-receptor agonist (GLP-1RA) Liraglutide is authorised as a treatment for people with Type 2 diabetes. Randomised clinical trials (RCTs) including the LEADER trial have also shown cardioprotective effects of Liraglutide and other GLP-1RAs. An analysis of secondary outcomes of the LEADER trial has however also suggested an increased risk for any cancer after Liraglutide use. However, the study was not powered for this outcome.; This non-interventional study is aiming to emulate the LEADER trial using causal inference methodology on healthcare claims data, with a focus on the outcomes of; 1) Endometrial cancer; 2) Thyroid cancer; 3) Pancreatic cancer; 4) Prostate cancer; This emulation aims to replicate the exposures and eligibility criteria of the LEADER trial, which randomized patients with diabetes and high cardiovascular risk to liraglutide or placebo and evaluated the outcome of major adverse cardiovascular events (MACE). This study will benchmark results for the MACE outcome against the LEADER trial, expand to evaluate the cancer outcomes of interest, and expand the treatment group to include new users of any GLP-1RA. The control group consists of new users of DPP4 inhibitors (DPP4i), as an active comparator to emulate placebo assignment from the LEADER trial. Randomisation is emulated through propensity-score matching observations based on relevant covariates. ;
• Study status:
  Planned

Research institutions and networks

Institutions

Pharmacoepidemiology Research, Federal Institute for Drugs and Medical Devices (BfArM)

Germany

Brigham and Women's Hospital

Study timelines

Date when funding contract was signed

Planned:26/04/2026

Study start date

Planned:29/04/2026

Date of final study report

Planned:30/06/2026

Regulatory

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