Endocrinology, Diabetes, Type II, Obesity
Conditions
Keywords
Diabetes, Type II, Obesity
Brief summary
This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.
Detailed description
This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.
Interventions
DRUGAZD6234
Weekly SC injections of AZD6234
DRUGPlacebo to match
Weekly SC injections of matching placebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This study will be conducted as double-blind through its duration, with participants, investigators, and site staff remaining blinded to treatment allocation. At the time of the interim analysis, Sponsor and designated CRO staff will be unblinded to treatment allocations solely for statistical analysis or operational management. Investigators, site staff, and participants will remain blinded for the entire study duration.
Intervention model description
The study spans approx. 37 weeks per participant, including a screening period, a treatment period and a follow-up period. Around 64 eligible participants will be randomized to receive either AZD6234 or a matching placebo, in addition to their stable GLP-1 RA regimen. Treatments consist of weekly subcutaneous injections, with AZD6234 dosing adjustments allowed based on individual tolerance.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be 18 to 75 years old at the time of signing the informed consent. 2. Diagnosed with type 2 diabetes ≥ 180 days before screening. 3. HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol). 4. On a stable maintenance dose of an injectable GLP-1 RA. 5. At Screening, have a BMI ≥ 27 kg/m2
Exclusion criteria
1. Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA). 2. Self-reported weight change of \> 5 % in the 3 months prior to screening. 3. Diabetes mellitus that is not clearly type 2 diabetes. 4. Use of insulin therapy for T2DM 5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) 6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) 8\. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight from baseline at Study Week 26 | From baseline to week 26 | To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26 |
| Weight loss ≥ 5% from baseline at Study Week 26 | From baseline to week 26 | To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 5% from baseline at Study Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss ≥ 10% from baseline at Study Week 26 | From baseline to week 26 | To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 10% from baseline at Study Week 26 |
| Absolute change in body weight (kg) from baseline at Study Week 26 | From baseline to week 26 | To determine whether AZD6234 is superior to placebo for absolute weight reduction (kg) at Study Week 26 |
| Change in HbA1c from baseline at Study Week 26. | From baseline to week 26 | To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26 |
| AZD6234 plasma concentrations | From baseline to week 26 | To characterise the PK of AZD6234 |
| Change in serum glucose from baseline at Study Week 26. | From baseline to week 26 | To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26 |
Countries
United States
Outcome results
None listed