Obesity or Overweight
Conditions
Brief summary
A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity
Detailed description
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.
Interventions
DRUGAZD5004
AZD5004 film-coated tablet once daily during 36 weeks
DRUGPlacebo
Placebo matching AZD5004 film-coated tablet once daily during 36 weeks
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline | 26 weeks | To determine whether AZD5004 is superior to placebo for weight loss |
| Achieved Weight Loss ≥ 5% From Baseline | 26 weeks | To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline | 36 weeks | To determine whether AZD5004 is superior to placebo for weight loss |
| Achieved weight loss ≥ 5% from baseline | 36 weeks | To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline |
| Absolute change from baseline in body weight | Week 26 and Week 36 | To determine whether AZD5004 is superior to placebo for absolute weight loss |
| Achieved weight loss ≥ 10% as well as ≥ 15% from baseline | Week 26 and Week 36 | To assess the effect of AZD5004 versus placebo on achieving weight loss ≥ 10% as well as ≥ 15% from baseline |
Countries
Australia, Canada, Germany, Japan, Taiwan, United Kingdom, United States
Outcome results
None listed