A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Obesity or Overweight

Treatments: Drug: Placebo; Drug: AZD6234

Study type: Interventional

Funder types: Industry

Identifiers

NCT07784725

2025-523379-41-00 (EU Trial (CTIS) Number)

D8750C00014

159494 (Registry Identifier)

2025

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,500 participants in 3 patient groups, including a placebo group

AZD6234 Dose 1

Experimental group

Description:

AZD6234 Dose 1

Treatment:

Drug: AZD6234

AZD6234 Dose 2

Experimental group

Description:

AZD6234 Dose 2

Treatment:

Drug: AZD6234

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo