Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist
Purpose
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.
Conditions
- Endocrinology
- Diabetes, Type II
- Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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 ≥ 7.0% (53 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- 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.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- This is a double-blind study in which AstraZeneca, the study site staff, and participants remain blinded during the clinical study. All packaging and labelling of IMP will be done in such a way as to ensure blinding for all participants, AstraZeneca staff, and study site staff. Blinded investigators, blinded study site staff, and participants will remain blinded to each participant's assigned IMP throughout the course of the study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AZD6234 |
Weekly SC injections of AZD6234 |
|
|
Placebo Comparator Placebo for AZD6234 |
Weekly SC injections of matching placebo |
|
Recruiting Locations
Birmingham, Alabama 35205
Mobile, Alabama 36608
Doral, Florida 33166
Miami, Florida 33135
Winter Park, Florida 32789
Chicago, Illinois 60640
Oak Brook, Illinois 60523
Newton, Kansas 67114
Lexington, Kentucky 40509
Kansas City, Missouri 64114
Las Vegas, Nevada 89119
Norman, Oklahoma 73069
San Antonio, Texas 78229
More Details
- NCT ID
- NCT06851858
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
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.