Tests AZD6234 for weight management in adults with obesity or overweight

Trial details

Who runs it

AstraZeneca

Trial code

NCT07922330

Record updated

6 November 2026

Original description

This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.Read full original descriptionShow less

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE-Asia)

This study will evaluate the efficacy and safety of AZD6234 compared with placebo in adults who are overweight or obese, with or without type 2 diabetes mellitus.

Inclusion: Aged 18 years or older at the time of signing informed consent; Body mass index:; at least 28 kg/m²; or; at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, knee osteoarthritis, or stress urinary incontinence; Stable body weight (≤ 5% body weight change) for at least 3 months prior to Randomisation; Participants with type 2 diabetes mellitus must:; have been diagnosed at least 6 months before informed consent; have HbA1c between 6.0% and 10.0% at Screening; and; be managed with diet and exercise alone or with a stable dose of 1 to 3 oral glucose-lowering medications for at least 3 months before Screening; At least one previous self-reported unsuccessful attempt to lose body weight; Participants of childbearing potential must comply with protocol-defined highly effective contraception requirements and have negative pregnancy tests at Screening and Randomisation; Able to provide signed informed consent.

Exclusion: Severe heart failure, defined as New York Heart Association Class IV, or hospitalisation for heart failure within 3 months before Screening; Type 1 diabetes mellitus or ketoacidosis or hyperosmolar coma/state within 3 months before Screening; Significant inflammatory bowel disease or another severe disease or prior surgery affecting the upper gastrointestinal tract; Cardiovascular event, percutaneous coronary intervention, or coronary artery bypass graft within 3 months before Screening; Previous or planned surgical treatment for obesity; Known or suspected drug abuse or alcohol abuse; Planned elective surgery requiring discontinuation of study intervention for more than 6 weeks; Weight-management treatment within 3 months before Randomisation; Treatment with a glucagon-like peptide-1 receptor agonist or another glucagon-like peptide-1-containing medication within 3 months before Randomisation; Treatment with a marketed or investigational amylin-based compound within 3 months before Randomisation; Concomitant medication that may increase risk, affect study results, or interfere with study participation; Participation in another clinical study within 30 days before Screening; Previous randomisation in the present study; Obesity primarily caused by another endocrine disorder; Neoplastic disease within 5 years before Screening, except as otherwise permitted by the protocol; Clinically important disease or disorder that may place the participant at risk or interfere with study participation; Use of insulin therapy for type 2 diabetes mellitus; Unstable major depressive disorder or Patient Health Questionnaire-9 score of 15 or higher; History of psychosis or active symptomatic bipolar disorder; Active suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale, or history of a suicide attempt; Known hypersensitivity to AZD6234; Any other condition that, in the Investigator's judgement, makes participation inappropriate; Significant hepatobiliary disease, including protocol-defined elevations in alanine aminotransferase, aspartate aminotransferase, or total bilirubin; Clinically significant gastric-emptying abnormality requiring treatment; Uncontrolled hypothyroidism or hyperthyroidism; Long-term systemic glucocorticoid treatment lasting more than 14 days or use of central nervous system stimulants; Involvement in the planning and/or conduct of the study; Unlikely or unable to comply with study procedures, restrictions, or requirements; Currently pregnant or breastfeeding.

ClinicalTrials.gov NCT07922330