The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.
This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
377
Percent change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss
Time frame: 36 weeks
Weight loss ≥ 5% from baseline after 36 weeks of treatment
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5%
Time frame: 36 weeks
Absolute change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss
Time frame: 36 weeks
Absolute change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss
Time frame: 36 weeks
Weight loss ≥ 5% from baseline after 36 weeks of treatment
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 5%
Time frame: 36 weeks
Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo and monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 10% and ≥ 15%
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Research Site
Dothan, Alabama, United States
Research Site
Vestavia Hills, Alabama, United States
Research Site
Cerritos, California, United States
Research Site
Escondido, California, United States
Research Site
Huntington Park, California, United States
Research Site
Lincoln, California, United States
Research Site
Sacramento, California, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Palm Harbor, Florida, United States
Research Site
Decatur, Georgia, United States
...and 43 more locations
Time frame: 36 weeks
Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies
Time frame: 36 weeks
Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
To assess immunogenicity profile of ADAs to AZD9550 and AZD6234 in combination and as monotherapies
Time frame: 36 weeks
Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment
To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies
Time frame: 36 weeks
Percent change in body weight from baseline after 36 weeks of treatment
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss
Time frame: 36 weeks