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

NCT06579105 | Completed Phase 2 FDA Drug

• 2 other identifiers: D7261C000012024-512562-34-00
• Study Type: interventional
• Target: 406
• Locations: 9 countries
• Sites: 97

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  To evaluate the effect of AZD5004 versus placebo on glycemic control

  Baseline to Week 26

Secondary Outcomes (6)

• Change in fasting glucose

  Baseline to Weeks 4, 12, 16 and 26

• Achievement of HbA1c ≤ 6.5%

  Week 26

• Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%

  Week 26

• Percent change in body weight

  Baseline to Week 26

• Absolute change in body weight

  Baseline to Week 26

Study Arms (8)

Arm 1

EXPERIMENTAL

Participants will receive xx mg once daily dose of AZD5004

Drug: AZD5004

Arm 2

EXPERIMENTAL

Participants will receive xx mg once daily dose of AZD5004

Drug: AZD5004

Arm 3

EXPERIMENTAL

Participants will receive xx mg once daily dose of AZD5004

Drug: AZD5004

Arm 4

EXPERIMENTAL

Participants will receive xx mg once daily dose of AZD5004

Drug: AZD5004

Arm 5

EXPERIMENTAL

Participants will receive xx mg once daily dose of AZD5004

Drug: AZD5004

Arm 6

EXPERIMENTAL

Participants will receive xx mg once daily dose of AZD5004

Drug: AZD5004

Arm 7

ACTIVE COMPARATOR

Participants will receive once daily dose of Semaglutide as active comparator

Drug: Semaglutide

Arm 8

PLACEBO COMPARATOR

Participants will receive matching placebo for each AZD5004 arm

Drug: Placebo (placebo matching AZD5004 film-coated tablet)

Interventions

Placebo (placebo matching AZD5004 film-coated tablet) DRUG

Placebo film-coated tablet (matching AZD5004)

Arm 8

AZD5004 DRUG

AZD5004 film-coated tablet, once daily during 26 weeks

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Semaglutide DRUG

3-14 mg tablets of Semaglutide

Also known as: Rybelsus

Arm 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (97)

Research Site

Mobile, Alabama, 36608, United States

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Sheffield, Alabama, 35660, United States

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Vestavia Hills, Alabama, 35216, United States

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Tucson, Arizona, 85710, United States

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Little Rock, Arkansas, 72205, United States

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Long Beach, California, 90815, United States

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Los Angeles, California, 90017, United States

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Newport Beach, California, 92660, United States

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Sacramento, California, 95821, United States

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Waterbury, Connecticut, 06708, United States

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Lake City, Florida, 32055, United States

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Largo, Florida, 33777, United States

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Ocoee, Florida, 34761, United States

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Orlando, Florida, 32804, United States

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Decatur, Georgia, 30030, United States

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Savannah, Georgia, 31406, United States

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Lombard, Illinois, 60148, United States

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Potomac, Maryland, 20854, United States

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Boston, Massachusetts, 02115, United States

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Roslindale, Massachusetts, 02131, United States

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Farmington Hills, Michigan, 48334, United States

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Gulfport, Mississippi, 39503, United States

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Kansas City, Missouri, 64111, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89109, United States

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Albuquerque, New Mexico, 87107, United States

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Binghamton, New York, 13905, United States

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Durham, North Carolina, 27701, United States

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Greensboro, North Carolina, 27408, United States

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Rocky Mount, North Carolina, 27804, United States

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Statesville, North Carolina, 28625, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Beachwood, Ohio, 44122, United States

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Cincinnati, Ohio, 45219, United States

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Medford, Oregon, 97504, United States

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West Chester, Pennsylvania, 19380, United States

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Gaffney, South Carolina, 29340, United States

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Bristol, Tennessee, 37620, United States

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Abilene, Texas, 79606, United States

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Dallas, Texas, 75230, United States

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El Paso, Texas, 79935, United States

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Houston, Texas, 77004, United States

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West Jordan, Utah, 84088, United States

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Charlottesville, Virginia, 22911, United States

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Manassas, Virginia, 20110, United States

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Norfolk, Virginia, 23504, United States

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Seattle, Washington, 98105, United States

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Kingwood, West Virginia, 26537, United States

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Surrey, British Columbia, V3T 2V6, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Lévis, Quebec, G6V 6E2, Canada

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Falkensee, 14612, Germany

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Hamburg, 22607, Germany

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Münster, 48145, Germany

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Oldenburg, 23758, Germany

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Sankt Ingbert, 66386, Germany

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Wangen, 88239, Germany

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Budapest, 1036, Hungary

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Budapest, 1083, Hungary

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Debrecen, 4032, Hungary

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Szeged, 6725, Hungary

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Chūōku, 103-0027, Japan

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Chūōku, 104-0031, Japan

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Matsuyama, 7900034, Japan

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Shinjuku-ku, 160-0008, Japan

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Bialystok, 15-435, Poland

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Krakow, 31-156, Poland

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Krakow, 31-261, Poland

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Lodz, 90-338, Poland

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Lublin, 20-718, Poland

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Poznan, 60-589, Poland

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Poznan, 61-655, Poland

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Tarnów, 33-100, Poland

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Bratislava, 831 03, Slovakia

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Prešov, 080 01, Slovakia

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Rožňava, 048 01, Slovakia

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Sabinov, 083 01, Slovakia

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Trebišov, 07501, Slovakia

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A Coruña, 15006, Spain

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Barcelona, 8035, Spain

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Madrid, 28006, Spain

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Málaga, 29010, Spain

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Seville, 41003, Spain

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Seville, 41010, Spain

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Seville, 41950, Spain

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Blackpool, FY3 7EN, United Kingdom

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Bristol, BS34 6BQ, United Kingdom

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Chesterfield, S40 4AA, United Kingdom

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Corby, NN17 2UR, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Rotherham, S65 1DA, United Kingdom

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Yate, BS37 4AX, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking (blinding) applies to patients and investigators involved in AZD5004 and placebo arms, however not in active comparator arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: October 8, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

PL (8); ES (7); HU (4); JP (4); CA (6); GB (7); SL (5); US (50); DE (6)