A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight
About this study
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
- Condition
- Obesity or Overweight, Diabetes Mellitus, Type 2
- Tested
- AZD6234, Placebo
- Sponsor
- AstraZeneca
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Study condition: Obesity or Overweight, Diabetes Mellitus, Type 2
- 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 8
- 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
Where
227 sites, 223 recruiting
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Botany, Australia
Research Site
Camberwell, Australia
Research Site
Maroubra, Australia
Research Site
Waitara, Australia
Research Site
North York, Ontario, Canada
and 221 more sites on ClinicalTrials.gov
Contact
-
AstraZeneca Clinical Study Information Center
1-877-240-9479 information.center@astrazeneca.com
Potential match only. Final eligibility is determined by the study team.