Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT ID: NCT06579105
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
406 participants
INTERVENTIONAL
2024-10-08
2025-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Participants will receive xx mg once daily dose of AZD5004
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Arm 2
Participants will receive xx mg once daily dose of AZD5004
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Arm 3
Participants will receive xx mg once daily dose of AZD5004
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Arm 4
Participants will receive xx mg once daily dose of AZD5004
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Arm 5
Participants will receive xx mg once daily dose of AZD5004
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Arm 6
Participants will receive xx mg once daily dose of AZD5004
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Arm 7
Participants will receive once daily dose of Semaglutide as active comparator
Semaglutide
3-14 mg tablets of Semaglutide
Arm 8
Participants will receive matching placebo for each AZD5004 arm
Placebo (placebo matching AZD5004 film-coated tablet)
Placebo film-coated tablet (matching AZD5004)
Interventions
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Placebo (placebo matching AZD5004 film-coated tablet)
Placebo film-coated tablet (matching AZD5004)
AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Semaglutide
3-14 mg tablets of Semaglutide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Mobile, Alabama, United States
Research Site
Sheffield, Alabama, United States
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Vestavia Hills, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Sacramento, California, United States
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Waterbury, Connecticut, United States
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Lake City, Florida, United States
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Largo, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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Decatur, Georgia, United States
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Savannah, Georgia, United States
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Lombard, Illinois, United States
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Potomac, Maryland, United States
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Boston, Massachusetts, United States
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Roslindale, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Gulfport, Mississippi, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Binghamton, New York, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Medford, Oregon, United States
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West Chester, Pennsylvania, United States
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Gaffney, South Carolina, United States
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Bristol, Tennessee, United States
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Abilene, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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West Jordan, Utah, United States
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Charlottesville, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Kingwood, West Virginia, United States
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Surrey, British Columbia, Canada
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Brampton, Ontario, Canada
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Burlington, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Falkensee, , Germany
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Hamburg, , Germany
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Münster, , Germany
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Oldenburg, , Germany
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Sankt Ingbert, , Germany
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Wangen, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Chūōku, , Japan
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Chūōku, , Japan
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Matsuyama, , Japan
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Shinjuku-ku, , Japan
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Bialystok, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Tarnów, , Poland
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Bratislava, , Slovakia
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Prešov, , Slovakia
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Rožňava, , Slovakia
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Sabinov, , Slovakia
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Trebišov, , Slovakia
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A Coruña, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Blackpool, , United Kingdom
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Bristol, , United Kingdom
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Chesterfield, , United Kingdom
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Corby, , United Kingdom
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Dundee, , United Kingdom
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Rotherham, , United Kingdom
Research Site
Yate, , United Kingdom
Countries
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Other Identifiers
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2024-512562-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7261C00001
Identifier Type: -
Identifier Source: org_study_id
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