Obesity or Overweight
Conditions
Keywords
Obesity, Overweight
Brief summary
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity
Detailed description
The study will comprise of: A screening period of maximum 28 days A treatment period of 36 weeks A follow up period after last dose of study drug This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo
Interventions
DRUGAZD6234
IMP injected subcutaneously, once a week. Unit dose strength as per CSP
DRUGPlacebo comparator
Placebo matching IMP dose injected subcutaneously, once a week.
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
* Adults ≥ 18 years of age * BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated) * A stable body weight for 3 months prior to Screening (±5% body weight change)
Exclusion criteria
* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome * Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening * Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) * History of type 1 diabetes mellitus or T2DM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline to week 26 | 26 weeks | To determine whether AZD6234 is superior to placebo for weight loss |
| Weight loss ≥ 5% from baseline weight to week 26 | 26 weeks | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline to week 36 | 36 weeks | To determine whether AZD6234 is superior to placebo for weight loss |
| Weight loss ≥ 5% from baseline to week 36 | 36 weeks | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline |
| AZD6234 plasma concentrations | Week 43 | To characterise the PK of AZD6234 |
| Absolute change in body weight (kg) from baseline to week 26 and week 36 | week 26 and week 36 | To determine whether AZD6234 is superior to placebo for absolute weight loss |
| Weight loss ≥ 10% from baseline to week 36 | 36 weeks | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline |
Countries
Australia, Canada, Japan, United Kingdom, United States
Outcome results
None listed