Are you Struggling With Obesity, or Being Overweight?
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, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea.
The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks.
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 18 to 75 years of age inclusive.
- Have a BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity.
- Have a stable, self-reported body weight for 3 months prior to screening.
- Are Male or female: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Are female: must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
- Are capable of giving signed informed consent.
You may not qualify to participate if you:
- Have a history of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk.
- Have a history or presence of GI, renal, hepatic disease.
- Have had any previous or planned bariatric surgery or fitting of a weight loss device.
- Have obesity induced by endocrine disorders such as Cushing’s syndrome, insulinoma or Prader-Willi syndrome.
- Have any history of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control.
- Have a current HbA1c level ≥ 6.5% (48 mmol/mol), fasting serum glucose ≥ 126 mg/dL (7.0 mmol/L) or random glucose ≥ 200 mg/dL (11.1 mmol/L).
- Have any significant gastric and hepatobiliary disease.
- Have a history of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULN at screening.
- Have a history of psychosis or bipolar disorder.
- Have a history of major depressive disorder within the 2 years prior to screening or depression.
- Have received treatment with a GLP1 containing preparation, either as part of treatment or while participating in another clinical study within the 3 months or 5 half-lives of the drug prior to screening.
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.
