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Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

NCT06579105

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Diabetes Mellitus, Type 2

Interventions: Placebo (placebo matching AZD5004 film-coated tablet), AZD5004, Semaglutide

Countries: United States, Canada, Germany, Hungary, Japan, Poland, Slovakia, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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.

Locations (97)

Mobile, Alabama, United States
Sheffield, Alabama, United States
Vestavia Hills, Alabama, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Sacramento, California, United States
Waterbury, Connecticut, United States
Lake City, Florida, United States
Largo, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Lombard, Illinois, United States
Potomac, Maryland, United States
Boston, Massachusetts, United States
Roslindale, Massachusetts, United States
Farmington Hills, Michigan, United States
Gulfport, Mississippi, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Rocky Mount, North Carolina, United States
+ 67 more on CT.gov