A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus
Eluminate-5
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared With Elecoglipron Alone and Dapagliflozin Alone, in Adults With Type 2 Diabetes Mellitus (Eluminate-5)
2 other identifiers
interventional
2,000
23 countries
272
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Jul 2026
Typical duration for phase_3 type-2-diabetes-mellitus
272 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 23, 2026
CompletedStudy Start
First participant enrolled
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 5, 2028
July 15, 2026
July 1, 2026
2 years
June 18, 2026
July 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Hemoglobin A1c (HbA1c)
Baseline to Week 40
Secondary Outcomes (10)
Change from baseline in Hemoglobin A1c (HbA1c)
Baseline to Week 40
Achievement of HbA1c < 7% (53 mmol/mol)
Week 40
Percent change in body weight
Baseline to Week 40
Change from baseline in body weight
Baseline to Week 40
Change from baseline in Fasting Plasma Glucose (FPG)
Baseline to Week 40
- +5 more secondary outcomes
Study Arms (5)
Elecoglipron dose level 1 + dapagliflozin
EXPERIMENTALParticipants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.
Elecoglipron dose level 2 + dapagliflozin
EXPERIMENTALParticipants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.
Elecoglipron dose level 1 + dapagliflozin-matched placebo
EXPERIMENTALParticipants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
Elecoglipron dose level 2 + dapagliflozin-matched placebo
EXPERIMENTALParticipants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
Elecoglipron-matched placebo + dapagliflozin
ACTIVE COMPARATORParticipants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.
Interventions
Elecoglipron is administered orally once daily.
Dapagliflozin administered orally once daily.
A placebo matching elecoglipron administered orally once daily.
A placebo matching dapagliflozin administered orally once daily.
Eligibility Criteria
You may qualify if:
- Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
- T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
- HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- Body mass index (BMI) of ≥ 23 kg/m2 at screening
- Stable body weight (self-reported or documented) for 90 days prior to screening
You may not qualify if:
- Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
- Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
- Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
- History of acute or chronic pancreatitis
- Severe congestive heart failure (New York Heart Association IV)
- History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (272)
Research Site
Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Sheffield, Alabama, 35660, United States
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Little Rock, Arkansas, 72205, United States
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Bakersfield, California, 93309, United States
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Los Angeles, California, 90017, United States
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Ontario, California, 91762, United States
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Lake City, Florida, 32055, United States
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Lakeland, Florida, 33813, United States
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Atlanta, Georgia, 30315, United States
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Chicago, Illinois, 60640, United States
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Skokie, Illinois, 60077, United States
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Evansville, Indiana, 47714, United States
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Sioux City, Iowa, 51106, United States
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Zachary, Louisiana, 70791, United States
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Annapolis, Maryland, 21401, United States
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Lutherville-Timonium, Maryland, 21093, United States
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Oxon Hill, Maryland, 20745, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Troy, Michigan, 48098, United States
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Ridgeland, Mississippi, 39157, United States
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Elkhorn, Nebraska, 68022, United States
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Albuquerque, New Mexico, 87112, United States
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Brooklyn, New York, 11201, United States
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Raleigh, North Carolina, 27607, United States
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Beachwood, Ohio, 44122, United States
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Maumee, Ohio, 43537, United States
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Norman, Oklahoma, 73069, United States
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Kingsport, Tennessee, 37660, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75230, United States
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McKinney, Texas, 75069, United States
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Paris, Texas, 75462, United States
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San Antonio, Texas, 78229, United States
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South Jordan, Utah, 84095, United States
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Arlington, Virginia, 22205, United States
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Newport News, Virginia, 23606, United States
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Redmond, Washington, 98052, United States
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Kingwood, West Virginia, 26537, United States
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Buenos Aires, C1012AAR, Argentina
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Buenos Aires, C1425AGC, Argentina
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CABA, C1120AAC, Argentina
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Caba, C1128AAF, Argentina
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Ciudad de Buenos Aires, C1094AAD, Argentina
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Mar del Plata, B7600GNY, Argentina
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Rosario, S2000CVD, Argentina
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San Nicolás, B2900DMH, Argentina
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San Vicente, 5006, Argentina
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Barretos, 14784-400, Brazil
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Brasília, 71625-009, Brazil
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Campinas, 13060-904, Brazil
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Curitiba, 80030-480, Brazil
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Fortaleza, 60430-350, Brazil
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Natal, 59020-035, Brazil
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Porto Alegre, 90630-165, Brazil
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Rio de Janeiro, 22270-060, Brazil
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São José dos Campos, 12243-280, Brazil
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São Paulo, 01228-200, Brazil
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São Paulo, 04012-180, Brazil
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Baotou, China
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Beijing, 100044, China
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Beijing, 100050, China
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Beijing, 102218, China
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Changde, 415000, China
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Changsha, 410015, China
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Changzhou, 272100, China
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Chengdu, 610078, China
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Chengdu, 611130, China
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Chenzhou, 423000, China
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Chifeng, 024000, China
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Hangzhou, 310014, China
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Hefei, 230601, China
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Huai'an, 223005, China
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Jinan, 250031, China
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Jincheng, 048000, China
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Jining, 272006, China
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Jinzhou Shi, 121001, China
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Kaifeng, 475000, China
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Langfang, 065000, China
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Liangyugang, 222002, China
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Luoyang, 471009, China
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Meihekou, 135022, China
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Nanjing, 210011, China
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Nantong, 226001, China
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Nanyang, 473009, China
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Pinggu, 101200, China
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Pingxiang, 337055, China
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Sanya, 572000, China
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Shanghai, 200062, China
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Shanghai, 201199, China
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Shantou, 515065, China
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Shenyang, 110004, China
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Shenyang, 110023, China
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Shijiazhuang, 050000, China
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Shijiazhuang, 050001, China
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Tianjin, 300000, China
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Wuhan, 430010, China
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Wuhu, 241004, China
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Xi'an, 710077, China
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Xiangyang, 441000, China
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Xianyang, 712000, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yan’an, 716000, China
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Yueyang, 414000, China
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Zhumadian, 463000, China
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Zibo, 255499, China
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Hradec Králové, 500 02, Czechia
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Humpolec, 396 01, Czechia
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Jílové u Prahy, 254 01, Czechia
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Ostrava, 702 00, Czechia
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Prague, 147 00, Czechia
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Prague, 149 00, Czechia
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Prague, 160 00, Czechia
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Příbram, 261 01, Czechia
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Aarhus N, 8200, Denmark
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Esbjerg, 6700, Denmark
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Gandrup, 9362, Denmark
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Herlev, 2730, Denmark
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Hillerød, 3400, Denmark
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Hvidovre, 2650, Denmark
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Odense, 5000, Denmark
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Berlin, 13597, Germany
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Cologne, 51069, Germany
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Damme, 49401, Germany
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Deggingen, 73326, Germany
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Duisburg, 47269, Germany
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Essen, 45355, Germany
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Falkensee, 14612, Germany
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Frankfurt, 60596, Germany
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Hamburg, 22607, Germany
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Leipzig, 04249, Germany
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Münster, 48145, Germany
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Nittendorf, 93152, Germany
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Pohlheim, 35415, Germany
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Villingen-Schwenningen, 78048, Germany
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Wallerfing, 94574, Germany
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Weinheim, 69469, Germany
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Alexandroupoli, 68100, Greece
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Athens, 115 25, Greece
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Athens, 11527, Greece
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Athens, 17562, Greece
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Ioannina, 45500, Greece
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Thessaloniki, 54635, Greece
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Thessaloniki, 54642, Greece
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Thessaloniki, 54645, Greece
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Budapest, 1036, Hungary
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Budapest, 1089, Hungary
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Debrecen, 4032, Hungary
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Salgótarján, 3100, Hungary
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Szeged, 6725, Hungary
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Szolnok, 5000, Hungary
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Zalaegerszeg, 8900, Hungary
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Bangalore, 560 092, India
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Belagavi, 590006, India
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Belagavi, 590010, India
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Calicut, 673008, India
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Chennai, 600086, India
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Coimbatore, 641018, India
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Guwahati, 781032, India
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Indore, 452008, India
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Jaipur, 302017, India
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Kochi, 682040, India
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Kochi, 682041, India
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Lucknow, 226030, India
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Madurai, 625020, India
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Mumbai, 400012, India
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Nagpur, 440010, India
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New Delhi, 11029, India
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Thiruvananthapuram, 695031, India
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Chūōku, 103-0027, Japan
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Hachioji-shi, 192-0083, Japan
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Ichikawa-shi, 272-8516, Japan
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Kishiwada-shi, 596-8501, Japan
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Meguro-ku, 153-0053, Japan
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Mito, 310-0826, Japan
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Sapporo, 060-0061, Japan
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Shinjuku-ku, 160-0008, Japan
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Yamato-shi, 242-0004, Japan
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Alor Star, 05400, Malaysia
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Ipoh, 30450, Malaysia
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Kangar, 01000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Sarawak Miri, 98000, Malaysia
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Seremban, 70300, Malaysia
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Seri Manjung, 32040, Malaysia
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Cuernavaca, 62448, Mexico
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Bialystok, 15-897, Poland
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Częstochowa, 42-217, Poland
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Kielce, 25-355, Poland
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Lodz, 90-338, Poland
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Lublin, 20-718, Poland
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Poznan, 60-354, Poland
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Radom, 26-600, Poland
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Warsaw, 00-124, Poland
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Warsaw, 02-507, Poland
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San Juan, 00918, Puerto Rico
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Brackenfell, 7560, South Africa
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Cape Town, 7500, South Africa
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Cape Town, 7570, South Africa
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Claremont, 7708, South Africa
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Durban, 4091, South Africa
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Durban, 4093, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 1827, South Africa
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KwaDukuza, 4449, South Africa
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Paarl, 7646, South Africa
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Pretoria, South Africa
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Goyang-si, 411-706, South Korea
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Guri-si, 11923, South Korea
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Gwangju, 61453, South Korea
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Gyeonggi-do, 13620, South Korea
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Seoul, 03722, South Korea
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Seoul, 06273, South Korea
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Seoul, 136-705, South Korea
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Yangsan, 50612, South Korea
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Changhua, 500, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 813, Taiwan
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New Taipei City, 220, Taiwan
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New Taipei City, 24352, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433004, Taiwan
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Tainan, 70403, Taiwan
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Tainan County, 71044, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10400, Thailand
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Banphaeo, 74120, Thailand
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Changwat Sara Buri, 18000, Thailand
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Khlong Luang, 12120, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 70000, Thailand
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Mueang, 20000, Thailand
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Ratchathewi, 10400, Thailand
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Ankara, 06540, Turkey (Türkiye)
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Ankara, 6200, Turkey (Türkiye)
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Gaziantep, 27470, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Istanbul, 34265, Turkey (Türkiye)
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Istanbul, 34384, Turkey (Türkiye)
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Konya, 42130, Turkey (Türkiye)
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Kyiv, 02002, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03057, Ukraine
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Kyiv, 04114, Ukraine
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Kyiv, 04210, Ukraine
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Lviv, 79010, Ukraine
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Lviv, 79016, Ukraine
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Uzhhorod, 88002, Ukraine
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Uzhhorod, 88014, Ukraine
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Vinnytsia, 21001, Ukraine
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Blackburn, BB2 1AX, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Guisborough, TS14 7DJ, United Kingdom
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Nantwich, CW5 5NX, United Kingdom
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Rotherham, S65 1DA, United Kingdom
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Thetford, IP24 1JD, United Kingdom
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Weston-super-Mare, BS24 7PR, United Kingdom
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Witney, OX28 6JS, United Kingdom
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Woodbridge, IP136TH, United Kingdom
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Yate, BS37 4AX, United Kingdom
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh City, 700000, Vietnam
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Hochiminh, 700000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
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Huế, 530000, Vietnam
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Rach Gia, 920000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 23, 2026
Study Start
July 6, 2026
Primary Completion (Estimated)
July 5, 2028
Study Completion (Estimated)
July 5, 2028
Last Updated
July 15, 2026
Record last verified: 2026-07
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 rerefer 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.