Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
- Registration Number
- NCT06579092
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 310
-
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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 AZD5004 Active IMP Arm 2 AZD5004 Active IMP Arm 3 AZD5004 Active IMP Arm 4 AZD5004 Active IMP Arm 5 AZD5004 Active IMP Arm 6 Placebo Matching placebo for each of the 5 active arms
- Primary Outcome Measures
Name Time Method Percent change in body weight from baseline 26 weeks To determine whether AZD5004 is superior to placebo for weight loss
Proportion of participants with weight loss ≥ 5% from baseline weight 26 weeks To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline
- Secondary Outcome Measures
Name Time Method Percent change in body weight from baseline 36 weeks To determine whether AZD5004 is superior to placebo for weight loss
Proportion of participants with weight loss ≥ 5% 36 weeks To determine whether AZD5004 is superior to placebo on the proportion of participants with 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
Proportion of participants with weight loss ≥ 10% as well as ≥ 15% Week 26 and Week 36 To assess the effect of AZD5004 versus placebo on the proportion of participants with weight loss ≥ 10% as well as ≥ 15%
Trial Locations
- Locations (1)
Research Site
🇬🇧Witney, United Kingdom