A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. 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 ≥27 kg/m2
• Diagnosed with T2DM ≥90 days prior to Screening
• HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
• 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 lifetime

Exclusion criteria

• Obesity primarily caused by other endocrine disorders
• Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
• Significant hepatobiliary disease and/or any of the following results at Screening:

• ALT ≥ 3.0 X ULN
• AST ≥ 3.0 X ULN
• TBL > 1.5 X 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
• Use of insulin therapy for T2DM within 3 months prior to screening