A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
SELENE 1
A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)
4 other identifiers
interventional
2,500
16 countries
212
Brief Summary
The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment
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
212 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 5, 2026
CompletedStudy Start
First participant enrolled
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 21, 2029
August 25, 2026
August 1, 2026
2 years
August 5, 2026
August 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in body weight from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change
68 weeks
Secondary Outcomes (7)
Absolute change in weight (kg) from baseline at 68 weeks of treatment
68 weeks
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
68 weeks
Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment
68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
68 weeks
- +2 more secondary outcomes
Study Arms (3)
AZD6234 Dose 1
EXPERIMENTALAZD6234 Dose 1
AZD6234 Dose 2
EXPERIMENTALAZD6234 Dose 2
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Males \& females (inclusive of all gender identities) age ≥18 years
- BMI ≥30 kg/m2 OR BMI ≥27 kg/m2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
- Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
- History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime
You may not qualify if:
- Obesity primarily caused by other endocrine disorders
- History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening
- Significant hepatobiliary disease and/or any of the following results at Screening:
- ALT ≥ 3.0 × ULN
- AST ≥ 3.0 × ULN
- TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome)
- Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (212)
Research Site
Dothan, Alabama, 36305, United States
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Huntsville, Alabama, 35801, United States
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Mesa, Arizona, 85206, United States
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Escondido, California, 92025, United States
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Clearwater, Florida, 33765, United States
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Jacksonville, Florida, 32205, United States
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Stockbridge, Georgia, 30281, United States
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Champaign, Illinois, 61822, United States
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Chicago, Illinois, 60640, United States
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Ames, Iowa, 50010, United States
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Troy, Michigan, 48098, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64131, United States
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Butte, Montana, 59701, United States
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Las Vegas, Nevada, 89101, United States
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Jersey City, New Jersey, 07306, United States
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Cortland, New York, 13045, United States
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Statesville, North Carolina, 28625, United States
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Fargo, North Dakota, 58104, United States
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Columbus, Ohio, 43215, United States
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Tulsa, Oklahoma, 74133, United States
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Portland, Oregon, 97202, United States
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Philadelphia, Pennsylvania, 19107, United States
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Smithfield, Pennsylvania, 15478, United States
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Kingsport, Tennessee, 37660, United States
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Houston, Texas, 77043, United States
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San Antonio, Texas, 78231, United States
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Sugar Land, Texas, 77478, United States
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Waco, Texas, 76710, United States
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Salt Lake City, Utah, 84124, United States
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Arlington, Virginia, 22206, United States
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Renton, Washington, 98057, United States
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Seattle, Washington, 98104, United States
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Buenos Aires, C1425AGC, Argentina
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CABA, C1120AAC, Argentina
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Ciudad de Buenos Aires, C1094AAD, Argentina
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Mendoza, 5500, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Rosario, S2000PBJ, Argentina
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San Nicolás, B2900DMH, Argentina
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Botany, 2019, Australia
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Kotara, 2289, Australia
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Malvern, 3144, Australia
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St Albans, 3021, Australia
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St Leonards, 2065, Australia
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Waitara, 2077, Australia
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Belo Horizonte, 30150-320, Brazil
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Brasília, 71625-009, Brazil
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Campinas, 13060-904, Brazil
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Campinas, 13087-567, Brazil
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Curitiba, 80030-480, Brazil
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Curitiba, 80230-130, Brazil
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Curitiba, 80810-040, 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, 04266-010, Brazil
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Montana, 3400, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1618, Bulgaria
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Varna, 9010, Bulgaria
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Yambol, 8600, Bulgaria
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Calgary, Alberta, T3R 1W9, Canada
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New Westminster, British Columbia, V3L 3W4, Canada
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Surrey, British Columbia, V3S 2N6, Canada
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Victoria, British Columbia, V8V 4A1, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Truro, Nova Scotia, B2N 1L2, Canada
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Brampton, Ontario, L6T 0G1, Canada
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Guelph, Ontario, N1H 1B1, Canada
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Hamilton, Ontario, L8L 5G8, Canada
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Mississauga, Ontario, L5K2L3, Canada
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North York, Ontario, M6B 3H7, Canada
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Scarborough Village, Ontario, M1R 0B1, Canada
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Stoney Creek, Ontario, L8J 3W2, Canada
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Stouffville, Ontario, L4A1H2, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Montreal, Quebec, H4N 2W2, Canada
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Québec, Quebec, G1V 4T3, Canada
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Québec, Quebec, G2J 0C4, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Sherbrooke, Quebec, J1L 0K3, Canada
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Beijing, 100000, China
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Cangzhou, 061001, China
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Changchun, 130011, China
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Changchun, 130041, China
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Changsha, 410006, China
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Chengdu, 610021, China
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Danyang, 212399, China
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Ganzhou, 341000, China
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Guiyang, 550044, China
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Hengshui, 053099, China
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Huizhou, 516002, China
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Lanzhou, 730000, China
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Panjin, 124009, China
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Qiqihar, 161005, China
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Shanghai, 200032, China
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Suzhou, 215006, China
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Xiamen, 361101, China
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Xianyang, 712000, China
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Zigong, 643000, China
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Benešov, 256 01, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Brno, 602 00, Czechia
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Hodonín, 695 01, Czechia
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Kladno, 272 01, Czechia
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Ostrava, 702 00, Czechia
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Prague, 104 00, Czechia
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Prague, 116 94, Czechia
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Prague, 140 00, Czechia
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Prague, 149 00, Czechia
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Prague, 150 00, Czechia
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Prague, 19800, Czechia
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Štětí, 411 08, Czechia
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Bobigny, 93000, France
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Colmar, 68024, France
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Dijon, 21000, France
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Paris, 75900, France
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Pessac, 33604, France
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Pierre-Bénite, 69495, France
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Thionville, 57100, France
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Toulouse, 31059, France
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Vénissieux, 69200, France
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Berlin, 10117, Germany
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Berlin, 10629, Germany
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Berlin, 10787, Germany
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Bochum, 44789, Germany
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Bünde, 32257, Germany
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Dresden, 01069, Germany
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Frankfurt, 60590, Germany
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Frankfurt, 60596, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Hamburg, 20095, Germany
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Hamburg, 20253, Germany
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Hanover, 30159, Germany
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Homburg, 66421, Germany
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Jerichow, 39319, Germany
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Karlsruhe, 76137, Germany
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Leipzig, 04177, Germany
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Magdeburg, 39110, Germany
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Mainz, 55128, Germany
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München, 80339, Germany
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München, 81667, Germany
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Offenbach, 63065, Germany
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Schwerin, 19055, Germany
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Wiesbaden, 65189, Germany
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Bhubaneswar, 751019, India
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Coimbatore, 641009, India
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Hyderabad, 500048, India
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Indore, 452008, India
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Jaipur, 302001, India
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Jodhpur, 342005, India
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Kochi, 682041, India
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Kolkata, 700014, India
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Noida, 201310, India
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Pune, 411021, India
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Pune, 411057, India
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Siliguri, 734012, India
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Surat, 395002, India
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Vijayawada, 520 008, India
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Bologna, 40138, Italy
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Milan, 20138, Italy
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Milan, 20149, Italy
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Palermo, 90127, Italy
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Pisa, 56100, Italy
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Roma, 128, Italy
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Rozzano, 20089, Italy
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Sesto San Giovanni, 20099, Italy
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Torino, 10126, Italy
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Chūōku, 103-0025, Japan
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Chūōku, 103-0027, Japan
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Fukuoka, 812-0025, Japan
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Hachioji-shi, 192-0071, Japan
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Osaka, 540-0001, Japan
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Shibuya-ku, 151-0051, Japan
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Takatsuki-shi, 569-1192, Japan
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Bialystok, 15-481, Poland
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Elblag, 82-300, Poland
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Gdynia, 81-338, Poland
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Katowice, 40-081, Poland
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Katowice, 40-772, Poland
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Krakow, 30-105, Poland
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Krakow, 31-271, Poland
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Legnica, 59-220, Poland
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Lodz, 90-132, Poland
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Lodz, 90-338, Poland
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Poznan, 60-354, Poland
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Radzionków, 41-922, Poland
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Warsaw, 00-719, Poland
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Warsaw, 03-291, Poland
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Wroclaw, 53-673, Poland
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Anyang, 14068, South Korea
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Bucheon-si, 14754, South Korea
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Daegu, 41944, South Korea
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Seoul, 02841, South Korea
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Seoul, 04763, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Yangsan, 50612, South Korea
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Changhua, 500, Taiwan
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Chiayi City, 600, Taiwan
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Kaohsiung City, 80756, Taiwan
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New Taipei City, 24352, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan, 333, Taiwan
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2026
First Posted
August 25, 2026
Study Start
August 19, 2026
Primary Completion (Estimated)
August 11, 2028
Study Completion (Estimated)
May 21, 2029
Last Updated
August 25, 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.