Study of Weekly Injections of GIP and Cagrilintide Hormones for Stomach Side Effects in Women with Overweight or Obesity

What this Trial Is About

Researchers are evaluating the safety and effects of combining two medicines, cagrilintide and NNC0480-0389, in women living with overweight and obesity. This study compares taking both medicines together to taking cagrilintide alone. These medicines are new and are being tested to help people with type 2 diabetes andor overweight or obesity. The study is a Phase 1 clinical trial sponsored by Novo Nordisk AS and will last about 4.5 months. Participants will receive weekly injections of two hormones glucose-dependent insulinotropic polypeptide GIP and cagrilintide, or cagrilintide with a placebo version of GIP that looks like the real medicine but has no active ingredient. The study has two treatment periods where doses of GIP and cagrilintide escalate from low to high. Participants are randomly assigned to different sequences of receiving either the combination or the placebo. Both medicines are given as injections under the skin. During the study, participants will be monitored for side effects such as nausea, vomiting, and diarrhea. Researchers will track any treatment-related adverse events from the start of medicine administration through the end of treatment and follow-up visits. Participants will have regular assessments including physical exams, vital signs, laboratory tests, and electrocardiograms. The total study duration for each participant is about 4.5 months with close safety monitoring throughout.

A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese