A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
Elevate-CKD
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)
2 other identifiers
interventional
7,000
31 countries
419
Brief Summary
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
Typical duration for phase_3
419 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
August 4, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedStudy Start
First participant enrolled
August 28, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2030
Study Completion
Last participant's last visit for all outcomes
October 4, 2030
August 10, 2026
August 1, 2026
4.1 years
August 4, 2026
August 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality
Time to the first occurrence of any component of this composite: * ≥ 50% sustained decline in eGFR * ESKD defined as: Sustained eGFR \< 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant \- All-cause mortality
Event-driven, trial is estimated to be up to 4.5 years
Secondary Outcomes (9)
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or CV and renal death
Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke
Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)
Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality
Event-driven, trial is estimated to be up to 4.5 years
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death
Event-driven, trial is estimated to be up to 4.5 years
- +4 more secondary outcomes
Study Arms (2)
Elecoglipron
EXPERIMENTALElecoglipron tablet once daily
Placebo
ACTIVE COMPARATORPlacebo matching Elecoglipron tablet once daily
Interventions
Eligibility Criteria
You may qualify if:
- Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
- On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.
You may not qualify if:
- BMI \<23 kg/m² at screening
- History of type 1 diabetes mellitus
- HbA1c ≥10% (86 mmol/mol) at screening
- 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 hypoglycemia unawareness
- Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
- 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
- History/family history (first degree) of medullary thyroid cancer or MEN2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (426)
Research Site
Sheffield, Alabama, 35660, United States
Research Site
Surprise, Arizona, 85374, United States
Research Site
Chula Vista, California, 91910, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Topeka, Kansas, 66606, United States
Research Site
Beltsville, Maryland, 20705, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
Troy, Michigan, 48098, United States
Research Site
Edina, Minnesota, 55435, United States
Research Site
Saint Paul, Minnesota, 55117, United States
Research Site
Eatontown, New Jersey, 07724, United States
Research Site
Albany, New York, 12205, United States
Research Site
Buffalo, New York, 14215, United States
Research Site
Mineola, New York, 11501, United States
Research Site
Morehead City, North Carolina, 28557, United States
Research Site
Shelby, North Carolina, 28150, United States
Research Site
Statesville, North Carolina, 28625, United States
Research Site
Wilmington, North Carolina, 28401, United States
Research Site
Wilmington, North Carolina, 28403, United States
Research Site
Maumee, Ohio, 43537, United States
Research Site
Rapid City, South Dakota, 57701, United States
Research Site
Knoxville, Tennessee, 37912, United States
Research Site
Morristown, Tennessee, 37813, United States
Research Site
Arlington, Texas, 76015, United States
Research Site
Dallas, Texas, 75246, United States
Research Site
Houston, Texas, 77054, United States
Research Site
Lubbock, Texas, 79430, United States
Research Site
Mesquite, Texas, 75149, United States
Research Site
San Antonio, Texas, 78230, United States
Research Site
Shenandoah, Texas, 77384, United States
Research Site
South Salt Lake, Utah, 84115, United States
Research Site
Norfolk, Virginia, 23502, United States
Research Site
Buenos Aires, C1056, Argentina
Research Site
Buenos Aires, C1060AAB, Argentina
Research Site
Caba, C1128AAF, Argentina
Research Site
CABA, C1425HFA, Argentina
Research Site
Ciudad de Buenos Aires, 1128, Argentina
Research Site
Ciudad de Buenos Aires, C1094AAD, Argentina
Research Site
Córdoba, X5006CBI, Argentina
Research Site
La Plata, B1900, Argentina
Research Site
Mar del Plata, 7600, Argentina
Research Site
Mar del Plata, B7600, Argentina
Research Site
Rosario, 2000, Argentina
Research Site
Rosario, S2000CVD, Argentina
Research Site
San Nicolás, B2900DMH, Argentina
Research Site
Santa Rosa, 6300, Argentina
Research Site
Castle Hill, 2154, Australia
Research Site
Fitzroy, 3065, Australia
Research Site
Gosford, 2250, Australia
Research Site
Perth, 6000, Australia
Research Site
Southport, 4215, Australia
Research Site
Wollongong, 2500, Australia
Research Site
Barretos, 14784-400, Brazil
Research Site
Belém, 66073-005, Brazil
Research Site
Belo Horizonte, 30150-320, Brazil
Research Site
Bragança Paulista, 12916-542, Brazil
Research Site
Brasília, 71625-009, Brazil
Research Site
Campina Grande do Sul, 83.430-000, Brazil
Research Site
Campinas, 13060-080, Brazil
Research Site
Campinas, 13092133, Brazil
Research Site
Curitiba, 80810-040, Brazil
Research Site
Joinville, 89227-680, Brazil
Research Site
Natal, 59020-035, Brazil
Research Site
Porto Alegre, 90020-090, Brazil
Research Site
Porto Alegre, 9061-000, Brazil
Research Site
Porto Alegre, 90630-165, Brazil
Research Site
Presidente Prudente, 19050-680, Brazil
Research Site
São José dos Campos, 12230-001, Brazil
Research Site
São Paulo, 01228-000, Brazil
Research Site
São Paulo, 01327-001, Brazil
Research Site
São Paulo, 04038-031, Brazil
Research Site
São Paulo, 05403-9000, Brazil
Research Site
Plovdiv, 4000, Bulgaria
Research Site
Calgary, Alberta, T3R 1W9, Canada
Research Site
Edmonton, Alberta, T6G 2G3, Canada
Research Site
Vancouver, British Columbia, V5Y 3W2, Canada
Research Site
Winnipeg, Manitoba, R2V 3M3, Canada
Research Site
Toronto, Ontario, M4G 3E8, Canada
Research Site
Waterloo, Ontario, N2T 0C1, Canada
Research Site
Montreal, Quebec, H4J 1C5, Canada
Research Site
Araucania, 4781151, Chile
Research Site
Osorno, 5311092, Chile
Research Site
Region Metropolitana, 7550000, Chile
Research Site
Santiago, 7510187, Chile
Research Site
Santiago, 8330034, Chile
Research Site
Temuco, 4810345, Chile
Research Site
Victoria, 4720000, Chile
Research Site
Viña del Mar, 2540488, Chile
Research Site
Hradec Králové, 50005, Czechia
Research Site
Humpolec, 396 01, Czechia
Research Site
Jilemnice, 514 01, Czechia
Research Site
Liberec, 46014, Czechia
Research Site
Mariánské Lázně, 35301, Czechia
Research Site
Náchod, 547 01, Czechia
Research Site
Nové Město na Moravě, 692 31, Czechia
Research Site
Nový Jičín, 741 01, Czechia
Research Site
Ostrava, 70030, Czechia
Research Site
Prague, 100 34, Czechia
Research Site
Prague, 130 00, Czechia
Research Site
Prague, 160 00, Czechia
Research Site
Tábor, 390 03, Czechia
Research Site
Třebíč, 674 01, Czechia
Research Site
Aalborg, 9000, Denmark
Research Site
Aarhus, 8200, Denmark
Research Site
Copenhagen E, 2100, Denmark
Research Site
Herlev, 2730, Denmark
Research Site
Herning, 7400, Denmark
Research Site
Holbæk, 4300, Denmark
Research Site
Roskilde, 4000, Denmark
Research Site
Helsinki, 00290, Finland
Research Site
Jyväskylä, 40620, Finland
Research Site
Oulu, 90220, Finland
Research Site
Tampere, 33100, Finland
Research Site
Tampere, 33101, Finland
Research Site
Turku, 20100, Finland
Research Site
Ahrensburg, 22926, Germany
Research Site
Bad Mergentheim, 97980, Germany
Research Site
Bad Nenndorf, 31542, Germany
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 10249, Germany
Research Site
Berlin, 10787, Germany
Research Site
Berlin, 12203, Germany
Research Site
Bonn, 53127, Germany
Research Site
Brandenburg an der Havel, 14770, Germany
Research Site
Braunschweig, 38126, Germany
Research Site
Chemnitz, 09116, Germany
Research Site
Cloppenburg, 49661, Germany
Research Site
Cuxhaven, 27472, Germany
Research Site
Dortmund, 44137, Germany
Research Site
Dresden, 1307, Germany
Research Site
Duisburg, 47269, Germany
Research Site
Erlangen, 91054, Germany
Research Site
Essen, 45122, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Frankfurt am Main, 60431, Germany
Research Site
Freiburg im Breisgau, 79110, Germany
Research Site
Fulda, 36037, Germany
Research Site
Gladbeck, 45968, Germany
Research Site
Goslar, 38642, Germany
Research Site
Göttingen, 37075, Germany
Research Site
Hamburg, 21109, Germany
Research Site
Hamburg, 22041, Germany
Research Site
Hamburg, 22143, Germany
Research Site
Hanover, 30159, Germany
Research Site
Hanover, 30625, Germany
Research Site
Herne, 44625, Germany
Research Site
Jerichow, 39319, Germany
Research Site
Kiel, 24105, Germany
Research Site
Landshut, 84034, Germany
Research Site
Leipzig, 04177, Germany
Research Site
Leipzig, 04179, Germany
Research Site
Lübeck, 23552, Germany
Research Site
Magdeburg, 39120, Germany
Research Site
Mainz, 55131, Germany
Research Site
Mannheim, 68167, Germany
Research Site
Nuremberg, 90443, Germany
Research Site
Nuremberg, 90471, Germany
Research Site
Reinfeld (Holstein), 23858, Germany
Research Site
Riesa, 01589, Germany
Research Site
Rostock, 18057, Germany
Research Site
Stuttgart, 70376, Germany
Research Site
Ulm, 89081, Germany
Research Site
Wiesbaden, 65189, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Alexandroupoli, 68100, Greece
Research Site
Athens, 11527, Greece
Research Site
Athens, 12462, Greece
Research Site
Athens, 15125, Greece
Research Site
Chios, 82100, Greece
Research Site
Heraklion, 71500, Greece
Research Site
Ioannina, 45500, Greece
Research Site
Larissa, 41500, Greece
Research Site
Pátrai, 26504, Greece
Research Site
Thessaloniki, 54642, Greece
Research Site
Thessaloniki, 54645, Greece
Research Site
Thessaloniki, 57001, Greece
Research Site
Szeged, 6725, Hungary
Research Site
Chennai, 600037, India
Research Site
Ashkelon, 78278, Israel
Research Site
Be’er Ya‘aqov, 70300, Israel
Research Site
Hadera, 38100, Israel
Research Site
Haifa, 34362, Israel
Research Site
Holon, 58100, Israel
Research Site
Kfar Saba, 4428164, Israel
Research Site
Nahariya, 22100, Israel
Research Site
Ramat Gan, 52621, Israel
Research Site
Rehovot, 76100, Israel
Research Site
Tiberias, 15208, Israel
Research Site
Alessandria, 15100, Italy
Research Site
Bari, 70124, Italy
Research Site
Bologna, 40138, Italy
Research Site
Catania, 95125, Italy
Research Site
Chieri, 10023, Italy
Research Site
Cinisello Balsamo, 20092, Italy
Research Site
Cosenza, 87100, Italy
Research Site
Feltre, 32032, Italy
Research Site
Foggia, 71100, Italy
Research Site
Naples, 80131, Italy
Research Site
Pavia, 27100, Italy
Research Site
Pordenone, 33170, Italy
Research Site
Ranica, 24020, Italy
Research Site
Rome, 00189, Italy
Research Site
San Fermo della Battaglia, 22020, Italy
Research Site
San Giovanni Rotondo, 71013, Italy
Research Site
Trieste, 34149, Italy
Research Site
Aira, 899-5421, Japan
Research Site
Akita, 010-8543, Japan
Research Site
Asahikawa-shi, 070-8530, Japan
Research Site
Chūōku, 103-0002, Japan
Research Site
Fujisawa-shi, 251-0041, Japan
Research Site
Fukuoka, 814-0180, Japan
Research Site
Hachioji-shi, 192-0083, Japan
Research Site
Hamamatsu, 431-3192, Japan
Research Site
Hiroshima, 734-8551, Japan
Research Site
Ichikawa-shi, 272-8516, Japan
Research Site
Ina-shi, 396-8555, Japan
Research Site
Iruma-Gun, 350-0495, Japan
Research Site
Izunokuni-shi, 410-2295, Japan
Research Site
Kamakura-shi, 247-0056, Japan
Research Site
Kanazawa, 920-8650, Japan
Research Site
Kasuga-shi, 816-0864, Japan
Research Site
Kasugai-shi, 486-8510, Japan
Research Site
Kawachinagano-shi, 586-8521, Japan
Research Site
Kitakyushu, 802-8555, Japan
Research Site
Kitakyushu-shi, 802-0077, Japan
Research Site
Kumamoto, 862-0950, Japan
Research Site
Kurume, 830-8543, Japan
Research Site
Kuwana-shi, 511-0061, Japan
Research Site
Matsumoto-shi, 390-1401, Japan
Research Site
Minatoku, 108-0073, Japan
Research Site
Minokamo Shi, 505-8510, Japan
Research Site
Moriyama-shi, 524-8524, Japan
Research Site
Nagoya, 451-8511, Japan
Research Site
Nagoya, 468-0009, Japan
Research Site
Naka, 311-0113, Japan
Research Site
Naka, 311-0133, Japan
Research Site
Okayama, 700-0804, Japan
Research Site
Okayama, 700-8557, Japan
Research Site
Osaka, 558-8558, Japan
Research Site
Osaka, 559-0012, Japan
Research Site
Oyama-shi, 323-0022, Japan
Research Site
Ōita, 870-0039, Japan
Research Site
Sakaishi, 593-8304, Japan
Research Site
Sakushu, 385-8558, Japan
Research Site
Sapporo, 060-0062, Japan
Research Site
Sapporo, 062-0931, Japan
Research Site
Sasebo-shi, 857-8511, Japan
Research Site
Shinjuku-ku, 160-0023, Japan
Research Site
Suita-shi, 565-0871, Japan
Research Site
Suwa-shi, 392-8510, Japan
Research Site
Takasago-shi, 676-0812, Japan
Research Site
Tsu, 514-8507, Japan
Research Site
Ushiku-shi, 300-1207, Japan
Research Site
Utsunomiya, 321-0151, Japan
Research Site
Yokohama, 230-8765, Japan
Research Site
Yokohama, 234-0054, Japan
Research Site
Yokohama, 236-0004, Japan
Research Site
Ipoh, 30990, Malaysia
Research Site
Bergen, 5021, Norway
Research Site
Bodø, 8005, Norway
Research Site
Drammen, 3004, Norway
Research Site
Grålum, 1714, Norway
Research Site
Haugesund, 5528, Norway
Research Site
Levanger, 7601, Norway
Research Site
Lørenskog, 1478, Norway
Research Site
Oslo, 0369, Norway
Research Site
Oslo, 0450, Norway
Research Site
Oslo, 0456, Norway
Research Site
Oslo, 0586, Norway
Research Site
Skedsmokorset, N-2020, Norway
Research Site
Skien, 3710, Norway
Research Site
Stavanger, N-4011, Norway
Research Site
Tromsø, N-9038, Norway
Research Site
Trondheim, 7006, Norway
Research Site
Tønsberg, 3116, Norway
Research Site
Chorrillos, Lima 9, Peru
Research Site
Lima, 14, Peru
Research Site
Lima, 15082, Peru
Research Site
Lima, 15088, Peru
Research Site
Lima, LIMA 01, Peru
Research Site
Lima, LIMA 27, Peru
Research Site
Davao City, 8000, Philippines
Research Site
Davao City, PH-8000, Philippines
Research Site
Iloilo City, 5000, Philippines
Research Site
Las Piñas, 1742, Philippines
Research Site
Manadaluyong City, 1552, Philippines
Research Site
Pasig, 1605, Philippines
Research Site
Quezon City, 0870, Philippines
Research Site
Quezon City, 1101, Philippines
Research Site
Quezon City, 1112, Philippines
Research Site
Będzin, 42-500, Poland
Research Site
Bialystok, 15-481, Poland
Research Site
Czeladź, 41-250, Poland
Research Site
Gmina Świecie, 86-100, Poland
Research Site
Katowice, 40-648, Poland
Research Site
Kwidzyn, 82-500, Poland
Research Site
Lodz, 92-213, Poland
Research Site
Lublin, 20-011, Poland
Research Site
Olsztyn, 10-117, Poland
Research Site
Olsztyn, 10-561, Poland
Research Site
Poznan, 60-355, Poland
Research Site
Poznan, 61-251, Poland
Research Site
Rzeszów, 35-205, Poland
Research Site
Tczew, 83-110, Poland
Research Site
Warsaw, 00-719, Poland
Research Site
Warsaw, 04-141, Poland
Research Site
Włocławek, 87-800, Poland
Research Site
Żywiec, 34-300, Poland
Research Site
Bucharest, 010507, Romania
Research Site
Bucharest, 011053, Romania
Research Site
Bucharest, 031141, Romania
Research Site
Bucharest, 060044, Romania
Research Site
Bucharest, 22328, Romania
Research Site
Cluj-Napoca, 400349, Romania
Research Site
Iași, 700515, Romania
Research Site
Oradea, 410001, Romania
Research Site
Oradea, 410032, Romania
Research Site
Oradea, 410469, Romania
Research Site
Oradea, 410562, Romania
Research Site
Ploieşti, 100179, Romania
Research Site
Timișoara, 300723, Romania
Research Site
Timișoara, 300736, Romania
Research Site
Belgrade, 11000, Serbia
Research Site
Belgrade, 11070, Serbia
Research Site
Belgrade, 11080, Serbia
Research Site
Kragujevac, 34000, Serbia
Research Site
Kruševac, 37000, Serbia
Research Site
Niš, 18000, Serbia
Research Site
Pančevo, 26101, Serbia
Research Site
Anyang-si, 14068, South Korea
Research Site
Busan, 49241, South Korea
Research Site
Cheonan-si, 31151, South Korea
Research Site
Daejeon, 34943, South Korea
Research Site
Goyang-si, 10380, South Korea
Research Site
Guri-si, 11923, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Badajoz, 06080, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Burgos, 09006, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Granada, 18014, Spain
Research Site
Madrid, 28041, Spain
Research Site
Majadahonda, 28222, Spain
Research Site
Málaga, 29010, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Valencia, 46010, Spain
Research Site
Valencia, 46026, Spain
Research Site
Falun, 79182, Sweden
Research Site
Gothenburg, 41345, Sweden
Research Site
Karlstad, 651 85, Sweden
Research Site
Linköping, 581 85, Sweden
Research Site
Lund, 221 85, Sweden
Research Site
Örebro, 70185, Sweden
Research Site
Stockholm, 141 86, Sweden
Research Site
Stockholm, SE-18288, Sweden
Research Site
Uppsala, 75185, Sweden
Research Site
Vaxjo, 352 34, Sweden
Research Site
Changhua, 500, Taiwan
Research Site
Kaohsiung City, 833, Taiwan
Research Site
New Taipei City, 220, Taiwan
Research Site
Taichung, 402, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taichung, 433004, Taiwan
Research Site
Tainan, 704, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 110, Taiwan
Research Site
Taipei, 11696, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
Yung Kang City, 71044, Taiwan
Research Site
Bangkok, 10210, Thailand
Research Site
Bangkok, 10220, Thailand
Research Site
Bangkok, 10300, Thailand
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Banphaeo, 74120, Thailand
Research Site
Hat Yai, 90110, Thailand
Research Site
Khlong Luang, 12120, Thailand
Research Site
Muang, 50200, Thailand
Research Site
Phitsanulok, 65000, Thailand
Research Site
Phutthamonthon, 73170, Thailand
Research Site
Ratchaburi, 70000, Thailand
Research Site
Ubonratchathani, 34000, Thailand
Research Site
Ivano-Frankivsk, 76018, Ukraine
Research Site
Kyiv, 01601, Ukraine
Research Site
Kyiv, 02002, Ukraine
Research Site
Kyiv, 03037, Ukraine
Research Site
Kyiv, 03049, Ukraine
Research Site
Kyiv, 03057, Ukraine
Research Site
Kyiv, 04114, Ukraine
Research Site
Kyiv, 04210, Ukraine
Research Site
Lviv, 79016, Ukraine
Research Site
Vinnytsia, 21001, Ukraine
Research Site
Vinnytsia, 21029, Ukraine
Research Site
Aberdeen, AB25 2ZN, United Kingdom
Research Site
Cardiff, CF14 4XW, United Kingdom
Research Site
Corby, NN18 9EZ, United Kingdom
Research Site
Coventry, CV3 4FJ, United Kingdom
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
Glasgow, G51 4TF, United Kingdom
Research Site
Liverpool, L9 7AL, United Kingdom
Research Site
London, EC1M 6BQ, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Research Site
Metropolitan Borough of Wirral, CH48 5AA, United Kingdom
Research Site
Northwood, HA6 2RN, United Kingdom
Research Site
Nottingham, NG7 2QW, United Kingdom
Research Site
Portsmouth, PO6 3LY, United Kingdom
Research Site
Shipley, BD18 3SA, United Kingdom
Research Site
Swansea, SN6 6NL, United Kingdom
Research Site
Thetford, IP24 1JD, United Kingdom
Research Site
York, YO21 8HE, United Kingdom
Research Site
Da Nang, 55000, Vietnam
Research Site
Haiphong, 180000, Vietnam
Research Site
Hanoi, 100000, Vietnam
Research Site
Hanoi, 10000, Vietnam
Research Site
Hà Nội, 100000, Vietnam
Research Site
Ho Chi Minh City, 7000000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Research Site
Ho Chi Minh City, 70000, Vietnam
Research Site
Hochiminh City, 700000, Vietnam
Research Site
Hồ Chí Minh, 700000, Vietnam
MeSH Terms
Conditions
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
- Masking Details
- Placebo controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2026
First Posted
August 10, 2026
Study Start (Estimated)
August 28, 2026
Primary Completion (Estimated)
October 4, 2030
Study Completion (Estimated)
October 4, 2030
Last Updated
August 10, 2026
Record last verified: 2026-08
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.