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

Not Yet RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Obesity or Overweight, Diabetes Mellitus, Type 2

Interventions: AZD6234, Placebo

Countries: United States, Argentina, Australia, Canada, Chile, China, Germany, Hungary

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (218)

Fairhope, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Gardena, California, United States
Lincoln, California, United States
Torrance, California, United States
Walnut Creek, California, United States
Coral Gables, Florida, United States
Fleming Island, Florida, United States
Fort Lauderdale, Florida, United States
Ocoee, Florida, United States
Woodstock, Georgia, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Lenexa, Kansas, United States
Newton, Kansas, United States
Monroe, Louisiana, United States
Beltsville, Maryland, United States
Lanham, Maryland, United States
Oxon Hill, Maryland, United States
North Dartmouth, Massachusetts, United States
Farmington Hills, Michigan, United States
Fayette, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
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