This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.
This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Weekly SC injections of AZD6234
Weekly SC injections of matching placebo
Research Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
Mobile, Alabama, United States
Percent change in body weight from baseline at Study Week 26
To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26
Time frame: From baseline to week 26
Weight loss ≥ 5% from baseline at Study Week 26
To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 5% from baseline at Study Week 26
Time frame: From baseline to week 26
Weight loss ≥ 10% from baseline at Study Week 26
To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 10% from baseline at Study Week 26
Time frame: From baseline to week 26
Absolute change in body weight (kg) from baseline at Study Week 26
To determine whether AZD6234 is superior to placebo for absolute weight reduction (kg) at Study Week 26
Time frame: From baseline to week 26
Change in HbA1c from baseline at Study Week 26.
To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26
Time frame: From baseline to week 26
AZD6234 plasma concentrations
To characterise the PK of AZD6234
Time frame: From baseline to week 26
Change in serum glucose from baseline at Study Week 26.
To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26
Time frame: From baseline to week 26
AstraZeneca Clinical Study Information Center
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Research Site
Doral, Florida, United States
RECRUITINGResearch Site
Jacksonville, Florida, United States
RECRUITINGResearch Site
Miami, Florida, United States
RECRUITINGResearch Site
Miami, Florida, United States
RECRUITINGResearch Site
Winter Park, Florida, United States
RECRUITINGResearch Site
Canton, Georgia, United States
RECRUITINGResearch Site
Macon, Georgia, United States
WITHDRAWNResearch Site
Chicago, Illinois, United States
RECRUITING...and 8 more locations