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

NCT07784725

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Obesity or Overweight

Interventions: AZD6234, Placebo

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, China, Czechia

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 ≥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.

Locations (212)

Dothan, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Escondido, California, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Stockbridge, Georgia, United States
Champaign, Illinois, United States
Chicago, Illinois, United States
Ames, Iowa, United States
Troy, Michigan, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Jersey City, New Jersey, United States
Cortland, New York, United States
Statesville, North Carolina, United States
Fargo, North Dakota, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Smithfield, Pennsylvania, United States
Kingsport, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Waco, Texas, United States
Salt Lake City, Utah, United States
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