A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity
The study will comprise of: A screening period of maximum 28 days A treatment period of 36 weeks A follow up period after last dose of study drug This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
262
IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Placebo matching IMP dose injected subcutaneously, once a week.
Percent change in body weight from baseline to week 26
To determine whether AZD6234 is superior to placebo for weight loss
Time frame: 26 weeks
Weight loss ≥ 5% from baseline weight to week 26
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline
Time frame: 26 weeks
Weight loss ≥ 5% from baseline to week 36
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline
Time frame: 36 weeks
Weight loss ≥ 10% from baseline to week 36
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline
Time frame: 36 weeks
Percent change in body weight from baseline to week 36
To determine whether AZD6234 is superior to placebo for weight loss
Time frame: 36 weeks
Absolute change in body weight (kg) from baseline to week 26 and week 36
To determine whether AZD6234 is superior to placebo for absolute weight loss
Time frame: week 26 and week 36
AZD6234 plasma concentrations
To characterise the PK of AZD6234
Time frame: Week 43
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Research Site
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Long Beach, California, United States
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Hialeah, Florida, United States
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Largo, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Woodstock, Georgia, United States
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Indianapolis, Indiana, United States
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Lutherville-Timonium, Maryland, United States
...and 31 more locations