A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants with Obesity or Overweight with at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus

Condition studied

Obesity or Overweight Weight-Related Comorbidity with/without Diabetes Mellitus, Type 2

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change in body weight from baseline at 68 weeks of treatment

Endpoint detail

Percent change in body weight from baseline at 68 weeks of treatment, Absolute change in weight from baseline at 68 weeks of treatment, Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment, Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment, Change in waist circumference from baseline at 68 weeks of treatment, Percent change in triglycerides from baseline at 68 weeks of treatment, Change in systolic blood pressure from baseline at 68 weeks of treatment, Change in HbA1c from baseline at 68 weeks of treatment, Occurrence and time to first occurrence of AE, serious AE (SAE), SAE with outcome death, AE leading to discontinuation of investigational intervention, AE leading to interruption of investigational intervention, other action taken related to investigational intervention, possibly related AE as assessed by Investigator, possibly related SAE as assessed by Investigator, Observed laboratory values change from baseline and time to first treatment emergent abnormality, Observed vital sign value (including systolic and diastolic blood pressure, pulse rate), change from baseline, and time to first treatment emergent abnormality, Observed ECG parameter, change from baseline, and time to first treatment emergent abnormality