Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity

This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

Inclusion criteria

• Adults ≥ 18 years of age.
• BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):

(i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea

• A stable body weight for 3 months prior to Screening (± 5% body weight change).

Exclusion criteria

• Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
• Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.
• Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
• History of type 1 diabetes mellitus or type 2 diabetes mellitus.
• Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
• History of acute or chronic pancreatitis.