Are you Struggling With Losing Weight?
The purpose of this study is to find out whether an experimental medication helps people living with obesity, to lose weight.
This is a Phase IIb, global, randomized, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo. The experimental medication will be given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with obesity and weight loss, and whether it will be made widely available to all Canadians trying to manage obesity. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are an adult, ≥ 18 years of age.
- Have a BMI of
- (a) ≥ 30 kg/m2, or
- (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):
- (i) Hypertension
- (ii) Dyslipidemia or hyperlipidemia
- (iii) CV disease
- (iv) Obstructive sleep apnea
- Have maintained a stable body weight for 3 months prior to Screening (± 5% body weight change)
You may not qualify to participate if you:
- Have obesity induced by other endocrine disorders, such as Cushing’s syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
- Have received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.
- Have had previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
- Have a history of type 1 diabetes mellitus or type 2 diabetes mellitus.
- Have clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- Have a history of acute or chronic pancreatitis.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
