Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06579105
- Lead Sponsor
- AstraZeneca
- 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 to placebo and active comparator.
- 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 to placebo and active comparator. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 384
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).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 4 AZD5004 Participants will receive xx mg once daily dose of AZD5004 Arm 5 AZD5004 Participants will receive xx mg once daily dose of AZD5004 Arm 6 AZD5004 Participants will receive xx mg once daily dose of AZD5004 Arm 1 AZD5004 Participants will receive xx mg once daily dose of AZD5004 Arm 2 AZD5004 Participants will receive xx mg once daily dose of AZD5004 Arm 3 AZD5004 Participants will receive xx mg once daily dose of AZD5004 Arm 7 Semaglutide Participants will receive once daily dose of Semaglutide as active comparator Arm 8 Placebo (placebo matching AZD5004 film-coated tablet) Participants will receive matching placebo for each AZD5004 arm
- Primary Outcome Measures
Name Time Method Change in HbA1c Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on glycemic control
- Secondary Outcome Measures
Name Time Method Change in fasting glucose Baseline to Weeks 4, 12, 16 and 26 To evaluate the effect of AZD5004 versus placebo on fasting glucose
Proportion of participants achieving HbA1c ≤ 6.5% and < 7.0% Week 26 To evaluate of the effect of AZD5004 versus placebo on HbA1c
Percent change in body weight Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on weight loss
Absolute change in body weight Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on weight loss
Proportion of participants with ≥ 5%, ≥ 10% and ≥ 15% weight reduction Week 26 To evaluate the effect of AZD5004 versus placebo on weight loss
Trial Locations
- Locations (1)
Research Site
🇬🇧Yate, United Kingdom