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NCT07784270
A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight
Conditions: Obesity or Overweight, Diabetes Mellitus, Type 2
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1500
Sponsor: AstraZeneca
Location: Research Site Fairhope Alabama
Summary
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07784270). StuddyBuddy aggregates publicly available trial information.