Obesity or Overweight
Conditions
Keywords
Obesity, Overweight, AZD9550, AZD6234
Brief summary
The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.
Detailed description
This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial 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. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 to 75 years of age inclusive. * BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity. * A stable, self-reported body weight for 3 months prior to screening. * Male and female participants: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. * Capable of giving signed informed consent.
Exclusion criteria
* History of any clinically important disease or disorder, which, in the opinion of the Investigator, may put the participant at risk. * History or presence of GI, renal, hepatic disease. * Previous or planned bariatric surgery or fitting of a weight loss device. * Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma or Prader-Willi syndrome. * History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control. * HbA1c ≥ 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). * Significant gastric and hepatobiliary disease. * History of acute or chronic pancreatitis or pancreatic amylase or lipase \> 2 × ULN at screening. * History of psychosis or bipolar disorder. * History of major depressive disorder within the 2 years prior to screening or depression. * 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. * Vulnerable populations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline after 36 weeks of treatment | 36 weeks | To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss |
| Weight loss ≥ 5% from baseline after 36 weeks of treatment | 36 weeks | To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in body weight from baseline after 36 weeks of treatment | 36 weeks | To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss |
| Weight loss ≥ 5% from baseline after 36 weeks of treatment | 36 weeks | To assess the effect of treatment with AZD9550 and AZD6234 in combination vs monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 5% |
| Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment | 36 weeks | To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo and monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥ 10% and ≥ 15% |
| Prevalence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment | 36 weeks | To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies |
| Incidence of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment | 36 weeks | To assess immunogenicity profile of ADAs to AZD9550 and AZD6234 in combination and as monotherapies |
| Titres of ADAs to AZD9550 and AZD6234 in combination and as monotherapies after 36 weeks of treatment | 36 weeks | To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies |
| Percent change in body weight from baseline after 36 weeks of treatment | 36 weeks | To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss |
Countries
Australia, Canada, Germany, Japan, United States
Outcome results
None listed