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

1500 patients around the world

Available in Argentina, Chile, United States

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.

AstraZeneca

1500Patients around the world

This study is for people with

Obesity

Diabetes

Diabetes mellitus type 2

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: 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.

StudySELENE 2

SponsorAstraZeneca

Study typeInterventional

Conditions

ObesityDiabetes mellitus type 2

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07784270