Obesity
Conditions
Interventions
Drug: AZD5004
Drug: Placebo
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults 18 years of age or more. - BMI (a) 30 kg/m2 or more, or (b) 27 kg/m2 or more 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percent change in body weight from baseline at Week 26 (Mesure Description: To determine whether AZD5004 is superior to placebo for weight loss) - Proportion of participants with weight loss 5% or more from baseline weight at Week 26 (Mesure Description: To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss 5% or more from baseline) | — |
Countries
Australia, Canada, Germany, Japan, Taiwan, United Kingdom, US
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed