5 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
The sponsor is developing a biological product (DRL_AB) similar to the approved medicine Orencia®. As part of medical-scientific studies to confirm the similarity of the biological products, the Sponsor wants to compare DRL_AB with EU-approved…
Primary To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus placebo as adjuncts to reduced-calorie diet andincreased physical activity in participants with overweight or obesity. Secondary To confirm superiority of…
Primary: to confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular event (MACE). Secondary: to confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time…
The main objective of this trial is to investigate glucagon receptor occupancy of BI 456906 in the liver with PET imaging using the radiolabeled tracer [68Ga]Ga-DO3A-VS-Cys40-Tuna-2.The secondary objectives is to investigate the GLP-1 receptor…