AZD6234 for adults with obesity or overweight and no type 2 diabetes

Trial details

Who runs it

AstraZeneca

Trial code

NCT07784725EU 2025-523379-41-00

Record updated

30 October 2026

Original description

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 treatmentRead 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 Without Type 2 Diabetes Mellitus (SELENE 1)

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

Inclusion: 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: Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation; 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).

ClinicalTrials.gov NCT07784725 · EU CTIS 2025-523379-41-00