Study of Weekly NNC0487-0111 Injections to Help Adults With Overweight or Obesity and Moderate-to-Severe Obstructive Sleep Apnoea Using Positive Airway Pressure

What this Trial Is About

Researchers are evaluating the effectiveness and safety of NNC0487-0111 in adults with overweight or obesity who also have obstructive sleep apnoea and are being treated with positive airway pressure. This phase 3 study compares NNC0487-0111 to a placebo, which contains no active medicine, to see how well the treatment helps with weight loss and improvement in sleep apnoea symptoms. Participants will receive one of two dose levels of NNC0487-0111 or a matching placebo as weekly injections under the skin. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment is administered using pre-filled pen injectors to the thigh, abdomen, or upper arm, and the study lasts for 80 weeks. Throughout the trial, participants will be monitored regularly to assess changes in body weight, sleep apnoea severity measured by the apnoea-hypopnoea index AHI, and other health measures such as waist and neck circumference, blood pressure, cholesterol, blood sugar, and sleep quality scores. Safety is tracked by recording any treatment-related adverse events. The study runs until week 80, with follow-up continuing through week 84 to evaluate ongoing safety and effectiveness.

AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea