A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

AstraZeneca

Status and phase: Not yet enrolling; Phase 3

Conditions: Obesity or Overweight; Diabetes Mellitus, Type 2

Treatments: Drug: AZD6234; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07784270

2025-524616-11-00 (EU Trial (CTIS) Number)

D8750C00012

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, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Enrollment: 1,500 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 ≥27 kg/m2
• Diagnosed with T2DM ≥90 days prior to Screening
• HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
• 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 lifetime

Exclusion criteria

• Obesity primarily caused by other endocrine disorders

• Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening

• Significant hepatobiliary disease and/or any of the following results at Screening:

  • ALT ≥ 3.0 X ULN
  • AST ≥ 3.0 X ULN
  • TBL > 1.5 X 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

• Use of insulin therapy for T2DM within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,500 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