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A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
NCT07784725 · AstraZeneca
In plain English
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Official title
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)
About this study
This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo, administered SC once weekly in adults with obesity or overweight with at least one weight-related comorbidity without T2DM. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Study design
Enrollment target: 2500 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-08-19
Estimated completion: 2029-05-21
Last updated: 2026-08-25
Interventions
Drug: AZD6234Drug: Placebo
Primary outcomes
- • Percent change in body weight from baseline at 68 weeks of treatment (68 weeks)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (212)
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Dothan, Alabama, United States
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Huntsville, Alabama, United States
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Mesa, Arizona, United States
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Escondido, California, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Stockbridge, Georgia, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Ames, Iowa, United States
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Troy, Michigan, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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Jersey City, New Jersey, United States
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Cortland, New York, United States
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Statesville, North Carolina, United States
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Fargo, North Dakota, United States
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Columbus, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Kingsport, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Arlington, Virginia, United States
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Renton, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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CABA, Argentina
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Ciudad de Buenos Aires, Argentina
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Mendoza, Argentina
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Ramos Mejía, Argentina
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Rosario, Argentina
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San Nicolás, Argentina
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Botany, Australia
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Kotara, Australia
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Malvern, Australia
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St Albans, Australia
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St Leonards, Australia
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Waitara, Australia
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Belo Horizonte, Brazil
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Brasília, Brazil
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Campinas, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Curitiba, Brazil
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Curitiba, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São José dos Campos, Brazil
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São Paulo, Brazil
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Montana, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Yambol, Bulgaria
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Calgary, Alberta, Canada
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New Westminster, British Columbia, Canada
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Surrey, British Columbia, Canada
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Victoria, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Truro, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Stoney Creek, Ontario, Canada
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Stouffville, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Beijing, China
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Cangzhou, China
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Changchun, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Danyang, China
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Ganzhou, China
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Guiyang, China
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Hengshui, China
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Huizhou, China
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Lanzhou, China
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Panjin, China
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Qiqihar, China
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Shanghai, China
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Suzhou, China
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Xiamen, China
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Xianyang, China
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Zigong, China
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Benešov, Czechia
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Brandýs nad Labem, Czechia
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Brno, Czechia
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Hodonín, Czechia
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Kladno, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Štětí, Czechia
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Bobigny, France
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Colmar, France
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Dijon, France
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Paris, France
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Pessac, France
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Pierre-Bénite, France
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Thionville, France
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Toulouse, France
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Vénissieux, France
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Bochum, Germany
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Bünde, Germany
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Dresden, Germany
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Frankfurt, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Göttingen, Germany
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Hamburg, Germany
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Hamburg, Germany
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Hanover, Germany
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Homburg, Germany
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Jerichow, Germany
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Karlsruhe, Germany
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Leipzig, Germany
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Magdeburg, Germany
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Mainz, Germany
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München, Germany
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München, Germany
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Offenbach, Germany
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Schwerin, Germany
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Wiesbaden, Germany
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Bhubaneswar, India
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Coimbatore, India
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Hyderabad, India
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Indore, India
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Jaipur, India
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Jodhpur, India
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Kochi, India
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Kolkata, India
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Noida, India
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Pune, India
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Pune, India
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Siliguri, India
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Surat, India
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Vijayawada, India
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Bologna, Italy
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Milan, Italy
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Palermo, Italy
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Pisa, Italy
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Roma, Italy
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Rozzano, Italy
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Sesto San Giovanni, Italy
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Torino, Italy
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Chūōku, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Hachioji-shi, Japan
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Osaka, Japan
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Shibuya-ku, Japan
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Takatsuki-shi, Japan
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Bialystok, Poland
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Elblag, Poland
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Gdynia, Poland
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Katowice, Poland
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Katowice, Poland
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Krakow, Poland
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Krakow, Poland
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Legnica, Poland
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Lodz, Poland
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Lodz, Poland
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Poznan, Poland
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Radzionków, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Anyang, South Korea
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Bucheon-si, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Yangsan, South Korea
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Changhua, Taiwan
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Chiayi City, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan