Evaluating AZD6234 for overweight or obese adults with type 2 diabetes on GLP-1 therapy
A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the 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
This study is testing if a new medication called AZD6234 can help overweight or obese adults with type 2 diabetes who are already using GLP-1 therapy manage their diabetes and lose weight better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 16 sites (Birmingham, Alabama and 15 other locations) |
| Trial ID | NCT06851858 on ClinicalTrials.gov |
What this trial studies
This Phase II study is a randomized, double-blind, placebo-controlled trial assessing the efficacy, safety, and tolerability of AZD6234 in adults aged 18-75 who are overweight or obese and have type 2 diabetes while on a stable dose of GLP-1 receptor agonist therapy. Participants will receive weekly subcutaneous injections of either AZD6234 or a placebo for a specified treatment period. The study aims to determine if AZD6234 can provide additional benefits in managing diabetes and weight in this population. A total of 64 participants will be enrolled across multiple sites in the USA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with type 2 diabetes, a BMI of 27 kg/m² or higher, and currently stable on GLP-1 receptor agonist therapy.
Not a fit: Patients who have undergone recent weight loss treatments or have significant renal or hepatobiliary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve diabetes management and weight control for patients already on GLP-1 receptor agonists.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific intervention is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥ 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: 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
Where this trial is running
Birmingham, Alabama and 15 other locations
- Research Site — Birmingham, Alabama, United States (Recruiting)
- Research Site — Mobile, Alabama, United States (Recruiting)
- Research Site — Doral, Florida, United States (Recruiting)
- Research Site — Jacksonville, Florida, United States (Recruiting)
- Research Site — Miami, Florida, United States (Recruiting)
- Research Site — Winter Park, Florida, United States (Recruiting)
- Research Site — Canton, Georgia, United States (Recruiting)
- Research Site — Macon, Georgia, United States (Withdrawn)
- Research Site — Chicago, Illinois, United States (Recruiting)
- Research Site — Oak Brook, Illinois, United States (Recruiting)
- Research Site — Newton, Kansas, United States (Recruiting)
- Research Site — Lexington, Kentucky, United States (Recruiting)
- Research Site — Kansas City, Missouri, United States (Recruiting)
- Research Site — Las Vegas, Nevada, United States (Recruiting)
- Research Site — Norman, Oklahoma, United States (Recruiting)
- Research Site — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.