Clinical trial NCT06579105: Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
Official title: A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 406
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change in fasting glucose
timeFrame: Baseline to Weeks 4, 12, 16 and 26
measure: Achievement of HbA1c ≤ 6.5%
timeFrame: Week 26
measure: Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%
timeFrame: Week 26
measure: Percent change in body weight
timeFrame: Baseline to Week 26
measure: Absolute change in body weight
timeFrame: Baseline to Week 26
measure: Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Sheffield
country: United States
facility: Research Site
state: Alabama
city: Vestavia Hills
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Lake City
country: United States
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state: Florida
city: Largo
country: United States
facility: Research Site
state: Florida
city: Ocoee
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Lombard
country: United States
facility: Research Site
state: Illinois
city: Potomac
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Roslindale
country: United States
facility: Research Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Gulfport
country: United States
facility: Research Site
state: Mississippi
city: Kansas City
country: United States
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state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Binghamton
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Rocky Mount
country: United States
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state: North Carolina
city: Statesville
country: United States
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state: North Carolina
city: Wilmington
country: United States
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state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Medford
country: United States
facility: Research Site
state: Oregon
city: West Chester
country: United States
facility: Research Site
state: Pennsylvania
city: Gaffney
country: United States
facility: Research Site
state: South Carolina
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: Abilene
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
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state: Texas
city: El Paso
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: West Jordan
country: United States
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state: Utah
city: Charlottesville
country: United States
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state: Virginia
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
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state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Kingwood
country: United States
facility: Research Site
state: West Virginia
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Sarnia
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Levis
country: Canada
facility: Research Site
state: Quebec
city: Falkensee
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Muenster
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Sankt Ingbert
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Roznava
country: Slovakia
facility: Research Site
city: Sabinov
country: Slovakia
facility: Research Site
city: Trebišov
country: Slovakia
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: La Coruna
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
city: Yate
country: United Kingdom
facility: Research Site
Study officials:
References: