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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
310
Percent change in body weight from baseline
To determine whether AZD5004 is superior to placebo for weight loss
Time frame: 26 weeks
Achieved Weight Loss ≥ 5% From Baseline
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
Time frame: 26 weeks
Percent change in body weight from baseline
To determine whether AZD5004 is superior to placebo for weight loss
Time frame: 36 weeks
Achieved weight loss ≥ 5% from baseline
To determine whether AZD5004 is superior to placebo on achieving weight loss ≥ 5% from baseline
Time frame: 36 weeks
Absolute change from baseline in body weight
To determine whether AZD5004 is superior to placebo for absolute weight loss
Time frame: Week 26 and Week 36
Achieved weight loss ≥ 10% as well as ≥ 15% from baseline
To assess the effect of AZD5004 versus placebo on achieving weight loss ≥ 10% as well as ≥ 15% from baseline
Time frame: Week 26 and Week 36
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Research Site
Chandler, Arizona, United States
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Huntington Park, California, United States
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La Mesa, California, United States
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Lincoln, California, United States
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Walnut Creek, California, United States
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Hialeah, Florida, United States
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Orlando, Florida, United States
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Lombard, Illinois, United States
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Valparaiso, Indiana, United States
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West Des Moines, Iowa, United States
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