The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment
Males & females (inclusive of all gender identities) age ≥18 years
BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime
Obesity primarily caused by other endocrine disorders
History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening
ALT ≥ 3.0 × ULN
AST ≥ 3.0 × ULN
Parallel
AZD6234
DrugIMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Placebo
DrugPlacebo matching IMP dose injected subcutaneously, once a week.
Percent change in body weight from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change
Absolute change in weight (kg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo on absolute change in weight
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5%
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 10%
Change in waist circumference (cm) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo on waist circumference change
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