Obesity or Overweight, Diabetes Mellitus, Type 2
Conditions
Keywords
Obesity, Overweight, AZD6234, Diabetes Mellitus, Type 2
Brief summary
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
Detailed 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.
Interventions
DRUGAZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
DRUGPlacebo
Placebo matching IMP dose injected subcutaneously, once a week.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline at 68 weeks of treatment. | 68 weeks | To evaluate the effect of AZD6234 compared to placebo in percent body weight change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in weight (kg) from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 compared to placebo on absolute change in weight |
| Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5% |
| Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10% |
| Change in haemoglobin A1C from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 on haemoglobin A1C change |
| Change in waist circumference (cm) from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 compared to placebo on waist circumference change |
| Percent change in triglycerides from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change |
| Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change |
| Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset | 68 weeks | Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants |
Countries
Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Japan, Poland, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed