Status:
ACTIVE_NOT_RECRUITING
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared t...
Detailed Description
This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared t...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age.
- Diagnosed with T2DM for at least 6 months.
- HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening.
- Body mass index of ≥ 23 kg/m2.
- Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).
Exclusion
- Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.
- History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.
- Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Received medication for weight loss within the last 3 months prior to screening.
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.
- Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
- History of acute or chronic pancreatitis.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2025
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT06579105
Start Date
October 8 2024
End Date
December 19 2025
Last Update
November 28 2025
Active Locations (97)
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1
Research Site
Mobile, Alabama, United States, 36608
2
Research Site
Sheffield, Alabama, United States, 35660
3
Research Site
Vestavia Hills, Alabama, United States, 35216
4
Research Site
Tucson, Arizona, United States, 85710