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A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus
A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

NCT07776509

Not Yet RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Obesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2

Interventions: AZD6234, Placebo

Countries: United States, Argentina, Brazil, Canada, China, Denmark, Israel, Japan

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
* For participants with T2DM only:

  * Diagnosed with T2DM ≥ 90 days prior to Screening
  * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
* Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
* Stable body weight (≤ 3% 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
* Type 1 diabetes mellitus
* 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)
* Use of insulin therapy for T2DM within 3 months prior to screening
Locations (88)
  • Escondido, California, United States
  • Lincoln, California, United States
  • Walnut Creek, California, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Stockbridge, Georgia, United States
  • Woodstock, Georgia, United States
  • Champaign, Illinois, United States
  • Chicago, Illinois, United States
  • Beltsville, Maryland, United States
  • Oxon Hill, Maryland, United States
  • Kansas City, Missouri, United States
  • Las Vegas, Nevada, United States
  • Somerset, New Jersey, United States
  • Statesville, North Carolina, United States
  • Fargo, North Dakota, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Smithfield, Pennsylvania, United States
  • Franklin, Tennessee, United States
  • Houston, Texas, United States
  • Manassas, Virginia, United States
  • Renton, Washington, United States
  • CABA, Argentina
  • CABA, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Rosario, Argentina
  • San Nicolás, Argentina
  • Belo Horizonte, Brazil
  • + 58 more on CT.gov