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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,500
Percent change in body weight from baseline at 68 weeks of treatment.
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
Time frame: 68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on absolute change in weight
Time frame: 68 weeks
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5%
Time frame: 68 weeks
Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10%
Time frame: 68 weeks
Change in haemoglobin A1C from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 on haemoglobin A1C change
Time frame: 68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on waist circumference change
Time frame: 68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change
Time frame: 68 weeks
AstraZeneca Clinical Study Information Center
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Research Site
Fairhope, Alabama, United States
RECRUITINGResearch Site
Huntsville, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Mobile, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Mesa, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGResearch Site
Bakersfield, California, United States
NOT_YET_RECRUITINGResearch Site
Gardena, California, United States
NOT_YET_RECRUITINGResearch Site
Lincoln, California, United States
RECRUITING...and 217 more locations
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change
Time frame: 68 weeks
Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset
Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants
Time frame: 68 weeks