AZD6234 for adults with obesity or overweight and no type 2 diabetes
Tests AZD6234 against placebo in adults with obesity or overweight.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Key facts
- Where
- Bologna, Milan, Palermo, Pisa, Rome, Rozzano, Sesto San Giovanni, and Turin, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNot yet recruiting
- Centro Cardiologico Monzino S.p.A.Milan, ItalyNot yet recruiting
- Istituto Auxologico ItalianoMilan, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
- Multimedica S.p.A.Sesto San Giovanni, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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).