Obesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2
Conditions
Keywords
Obesity, Overweight, AZD6234, Diabetes Mellitus, Type 2
Brief summary
The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.
Detailed description
This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM). Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively. Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.
Interventions
DRUGAZD6234
IMP injected subcutaneously, once a week.
DRUGPlacebo
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)
Intervention model description
International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males \& females (inclusive of all gender identities) age ≥18 years * BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence * For participants with T2DM only: * Diagnosed with T2DM ≥ 90 days prior to Screening * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication * Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation. * Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation * History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime
Exclusion criteria
* Obesity primarily caused by other endocrine disorders * Type 1 diabetes mellitus * Significant hepatobiliary disease and/or any of the following results at Screening: * ALT ≥ 3.0 × ULN * AST ≥ 3.0 × ULN * TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome) * Use of insulin therapy for T2DM within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change in the T2DM and non-T2DM sub-populations separately |
| Absolute change in weight (kg) from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the absolute change in weight in the full population and in the T2DM and non-T2DM sub-populations separately |
| Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 5% in the full population and in the T2DM and non T2DM sub-populations separately |
| Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in body weight loss of at least 10% in the full population and in the T2DM and non T2DM sub-populations separately |
| Change in waist circumference (cm) from baseline at 68 weeks of treatment | 68 weeks | To evaluate whether AZD6234 as an adjunct to incretin-based therapies on the waist circumference in the full population and in the T2DM and non-T2DM sub-populations separately |
| Percent change in triglycerides from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on triglycerides percent change |
| Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment | 68 weeks | To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies on the systolic blood pressure change |
| Change in HbA1c from baseline at 68 weeks of treatment | 68 weeks | For participants with T2DM only: to evaluate the effect of AZD6234 as an adjunct to incretin-based therapies on HbA1c change in the T2DM sub population only |
Countries
Argentina, Brazil, Canada, China, Denmark, Israel, Japan, Sweden, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed