Last updated 3 days ago
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
2500 patients around the world
Available in Argentina, Brazil, United States
This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo, administered SC once weekly in adults with obesity or overweight with at least one weight-related comorbidity without T2DM. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.
AstraZeneca
2500Patients around the world
This study is for people with
Obesity
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
StudySELENE 1
SponsorAstraZeneca
Study typeInterventional
Conditions
Obesity
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07784725
