A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus

This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo, administered SC once weekly in adults with obesity or overweight with at least one weight-related comorbidity without T2DM. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Inclusion criteria

• 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

Exclusion criteria

• 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
• Significant hepatobiliary disease and/or any of the following results at Screening:

• ALT ≥ 3.0 × ULN
• AST ≥ 3.0 × ULN
• TBL > 1.5 × ULN (except for cases of known Gilbert's Syndrome)
• Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.