The Phase 3 clinical trial investigating CagriSema (cagrilintide B and semaglutide I) for the treatment of Type 2 Diabetes Mellitus reached its primary completion on 2025-11-19. This significant milestone indicates that data collection for the study's main objectives has concluded, moving the trial closer to the analysis and potential disclosure of results.

Background

CagriSema is an investigational weekly medicine that combines two known therapeutic agents: semaglutide and cagrilintide. The trial aims to evaluate how effectively this combination lowers blood sugar and body weight in individuals with Type 2 Diabetes Mellitus. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, while cagrilintide is an amylin analogue.

Trial design

The study, identified as NCT06065540, is a Phase 3, randomized, controlled research study. It enrolled 2734 participants diagnosed with Type 2 Diabetes Mellitus. Participants in the trial were already being treated with metformin, either alone or in combination with an SGLT2 inhibitor. The study was designed to compare the efficacy and safety of CagriSema against its individual components, semaglutide and cagrilintide, when taken alone. Additionally, a placebo arm was included to provide a baseline for comparison. The primary objective of the study was to assess how well CagriSema, compared to the individual components and placebo, helps participants lower their blood sugar and body weight.

What this means

The primary completion of the Phase 3 trial for CagriSema signifies that all planned data collection for the main outcomes has been finalized. This stage is crucial as it precedes the comprehensive analysis of the collected data, which will determine the efficacy and safety profile of CagriSema in people with Type 2 Diabetes Mellitus. The results, once available, will provide important insights into the potential role of this combination therapy in managing the condition, particularly in comparison to existing treatments like semaglutide and cagrilintide monotherapy.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06065540, titled "A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor," was posted with a primary completion date of 2025-11-19 on clinicaltrials.gov.