Safety Study of Cagrilintide Compared to Placebo in Adults with Obesity Who Cannot Tolerate GLP-1-RA Treatments Due to Stomach Side Effects

What this Trial Is About

Researchers are evaluating the safety of the medicine Cagrilintide compared to a placebo in adults living with overweight or obesity who have stopped using glucagon-like peptide-1 receptor agonist GLP-1-RA therapies due to gastrointestinal side effects. This study is a randomized, double-blinded, placebo-controlled trial that aims to understand how well people tolerate Cagrilintide when other similar therapies are not suitable. The study is sponsored by Novo Nordisk AS and will last about 8 months. Participants will be randomly assigned to receive either Cagrilintide or a matching placebo, both administered as subcutaneous injections. The treatment period is 26 weeks long. The study is conducted in a parallel design, meaning each participant receives only one of the treatments. The main goal is to compare the percentage of participants who can stay on the standard or higher dose of Cagrilintide versus placebo at week 26. During the study, participants will be monitored regularly to assess their ability to tolerate the assigned treatment. The primary outcome measures whether participants remain on the standard or higher dose after 26 weeks. Safety and tolerability will be carefully observed throughout the treatment period. The total participation time is approximately 8 months, including screening and follow-up. Participants will not receive any active treatment if assigned to the placebo group, but all will be monitored closely for any side effects or issues.

Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events