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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT06579105

Run by

AstraZeneca

People needed

406

Starts

2024-10-08

Expected to finish

2025-12-19

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Research Site — Sheffield, Alabama, United States
• Research Site — Vestavia Hills, Alabama, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Sacramento, California, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Lake City, Florida, United States
• Research Site — Largo, Florida, United States
• Research Site — Ocoee, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Lombard, Illinois, United States
• Research Site — Potomac, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Roslindale, Massachusetts, United States
• Research Site — Farmington Hills, Michigan, United States
• Research Site — Gulfport, Mississippi, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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