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NCT07667803PHASE3Recruiting

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

AstraZeneca

Start Date

6/29/2026

Completion Date

7/30/2029

Summary

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Detailed Description

This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Legal age of consent and at least 18 years old * Study 1 - * BMI ≥ 30 kg/m2 or * 25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities: * Hypertension * Prediabetes * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea. * Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below: * Established diagnosis of T2DM * Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit * Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change) * History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria * Study 1 - Established diagnosis of T1DM or T2DM. * Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes: * T1DM * HbA1c ≥ 10% (86 mmol/mol) at the screening visit * 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 the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis * History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2

Interventions

DRUG

Elecoglipron

DRUG

Placebo

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Conditions

Weight Management

Locations

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Birmingham, Alabama 35205

United States

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Dothan, Alabama 36305

United States

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Chandler, Arizona 85225

United States

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Peoria, Arizona 85382

United States

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Little Rock, Arkansas 72205

United States

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Lynwood, California 90262

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Rolling Hills Estates, California 90274

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Sacramento, California 95821

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Arvada, Colorado 80002

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New Haven, Connecticut 06511

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Clearwater, Florida 33765

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Plantation, Florida 33324

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Woodstock, Georgia 30189

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Ammon, Idaho 83406

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Melrose Park, Illinois 60160

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Indianapolis, Indiana 46254

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Wichita, Kansas 67218

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Louisville, Kentucky 40213

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Alexandria, Louisiana 71303

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Baltimore, Maryland 21229

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Potomac, Maryland 20854

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White Marsh, Maryland 21162

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Ypsilanti, Michigan 48197

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Ridgeland, Mississippi 39157

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Kansas City, Missouri 64114

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St Louis, Missouri 63123

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Reno, Nevada 89511

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Albuquerque, New Mexico 87106

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Albany, New York 12205

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Laurelton, New York 11413

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Long Island City, New York 11106

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Greensboro, North Carolina 27408

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Raleigh, North Carolina 27609

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Rocky Mount, North Carolina 27804

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Statesville, North Carolina 28625

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Columbus, Ohio 43228

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Dayton, Ohio 45424

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Edmond, Oklahoma 73013

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Tulsa, Oklahoma 74133

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Portland, Oregon 97223

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DuBois, Pennsylvania 15801

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Newport, Pennsylvania 17074

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Philadelphia, Pennsylvania 19104

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East Providence, Rhode Island 02914

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Charleston, South Carolina 29407

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Gaffney, South Carolina 29340

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Rapid City, South Dakota 57701

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Franklin, Tennessee 37067

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Knoxville, Tennessee 37912

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Dallas, Texas 75254

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Houston, Texas 77081

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Humble, Texas 77346

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Irving, Texas 75063

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Sandy City, Utah 84070

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Midlothian, Virginia 23112

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Morgantown, West Virginia 26501

United States

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Buenos Aires, 1061

Argentina

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Buenos Aires, C1425AGC

Argentina

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CABA, 1056

Argentina

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CABA, C1120AAC

Argentina

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Caba, C1128AAF

Argentina

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Capital Federal, C1014A

Argentina

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Granadero Baigorria, S2152BOF

Argentina

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Lanus, B1824KAJ

Argentina

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Rosario, 2000

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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Botany, 2019

Australia

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Camberwell, 3124

Australia

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Kotara, 2289

Australia

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Maroubra, 2035

Australia

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St Albans, 3021

Australia

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St Leonards, 2065

Australia

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Belém, 66073-005

Brazil

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Brasília, 72145-450

Brazil

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Campinas, 13060-080

Brazil

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Campinas, 13092133

Brazil

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Curitiba, 80045-170

Brazil

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Fortaleza, 60430-350

Brazil

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Porto Alegre, 90430-001

Brazil

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São José dos Campos, 12230-001

Brazil

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São Paulo, 01228-000

Brazil

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São Paulo, 01236-030

Brazil

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São Paulo, 04012-180

Brazil

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Calgary, Alberta T2V 4J2

Canada

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Calgary, Alberta T3R 1W9

Canada

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Vancouver, British Columbia V5Y 3W2

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Victoria, British Columbia V8V 4A1

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Moncton, New Brunswick E1G 1A7

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Truro, Nova Scotia B2N 1L2

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Brampton, Ontario L6T 0G1

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Hamilton, Ontario L8L 5G8

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Niagara Falls, Ontario L2H 1H5

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North York, Ontario M6B 3H7

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Sarnia, Ontario N7T 4X3

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Scarborough Village, Ontario M1R 0B1

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Stouffville, Ontario L4A1H2

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Toronto, Ontario M3J 0K2

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Toronto, Ontario M6G 1M2

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Toronto, Ontario M9V 4B4

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Joliette, Quebec J6E 6A9

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Montreal, Quebec H4N 2W2

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Saint-Lambert, Quebec J4P 2H4

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Terrebonne, Quebec J6X 4P7

Canada

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Araucania, 4781151

Chile

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Concepción, 4070196

Chile

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Las Condes, 7560908

Chile

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Osorno, 5311092

Chile

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Providencia, 7500504

Chile

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Santiago, 7510187

Chile

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Santiago, 7691236

Chile

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Santiago, 8330034

Chile

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Santiago, 8331143

Chile

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Temuco, 4810345

Chile

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Binzhou, 256603

China

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Chengdu, 610078

China

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Chengdu, 610081

China

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Deyang, 618000

China

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Ganzhou, 341099

China

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Guangzhou, 510220

China

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Guangzhou, 510280

China

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Haikou, 570208

China

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Hangzhou, 310006

China

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Hangzhou, 311200

China

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Huaian, 223300

China

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Huzhou, 313003

China

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Jinan, 250001

China

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Jinzhou, 121002

China

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Kunming, CN-650034

China

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Lanzhou, 730000

China

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Linhai, 317000

China

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Liuzhou, 545006

China

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Luoyang, 471001

China

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Nanchang, 330006

China

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Nanjing, 210006

China

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Nanjing, 211100

China

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Nantong, 226001

China

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Ningbo, 315000

China

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Panjin, 124000

China

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Pingxiang, 337055

China

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Qingdao, 266035

China

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Shanghai, 200025

China

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Shanghai, 201200

China

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Shenyang, 110016

China

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Shenzhen, 518036

China

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Siping, 136000

China

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Suining, 629000

China

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Suzhou, 215006

China

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Ürümqi, 831118

China

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Wanzhou, 404000

China

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Wenzhou, 325000

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Wuhan, 430030

China

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Wuxi, 214023

China

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Xiangfan, 441021

China

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Xuancheng, 242000

China

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Yibin, 644000

China

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Yichang, 443003

China

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Zhengzhou, 450002

China

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Zhenjiang, 212002

China

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Zunyi, 563100

China

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Bad Oeynhausen, 32545

Germany

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Bochum, 44789

Germany

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Cologne, 50937

Germany

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Cologne, 51069

Germany

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Dresden, 01307

Germany

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Falkensee, 14612

Germany

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Gera, 07548

Germany

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Hamburg, 22607

Germany

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Leipzig, 04103

Germany

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Leipzig, 04107

Germany

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Lübeck, 23562

Germany

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Mainz, 55131

Germany

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Mannheim, 68167

Germany

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München, 80809

Germany

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Münster, 48145

Germany

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Nuremberg, 90443

Germany

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Obertshausen, 63179

Germany

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Oldenburg, 23758

Germany

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Stuttgart, 70199

Germany

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Ulm, 89073

Germany

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Wangen, 88239

Germany

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Würzburg, 97080

Germany

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Bangalore, 560 092

India

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Belagavi, 590006

India

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Bikaner, 334001

India

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Delhi, 110029

India

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Guntur, 522001

India

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Hyderabad, 500034

India

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Jodhpur, 342005

India

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Kolkata, 700014

India

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Kolkata, 700020

India

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Madurai, 625020

India

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Mumbai, 400008

India

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Mumbai, 400012

India

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Mysore, 570001

India

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Nagpur, 440010

India

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New Delhi, 110002

India

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Siliguri, 734012

India

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Bologna, 40138

Italy

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Catania, 95123

Italy

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Chieti, 66100

Italy

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Florence, 50134

Italy

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Latina, 04100

Italy

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Milan, 20154

Italy

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Pisa, 56100

Italy

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Ravenna, 48121

Italy

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Roma, 00128

Italy

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Roma, 161

Italy

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San Donato, 20097

Italy

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Amagasaki-shi, 660-0861

Japan

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Chūōku, 103-0002

Japan

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Chūōku, 1040031

Japan

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Kasugai-shi, 486-8510

Japan

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Koga-shi, 306-0232

Japan

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Maebashi, 371-8511

Japan

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Minatoku, 105-0004

Japan

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Minatoku, 108-0073

Japan

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Naka, 311-0113

Japan

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Shinjuku-ku, 169-0072

Japan

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Shizuoka, 424-0855

Japan

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Suita-shi, 564-8565

Japan

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Suita-shi, 565-0853

Japan

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Toshima-ku, 171-0014

Japan

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Yamato-shi, 242-0004

Japan

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Yokohama, 230-8765

Japan

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Yokohama, 232-0064

Japan

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Bialystok, 15-375

Poland

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Bialystok, 15-435

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Bydgoszcz, 85-796

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Kielce, 25-355

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Krakow, 30-727

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Krakow, 31-261

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Krakow, 31-271

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Lodz, 90-338

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Lublin, 20-064

Poland

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Lublin, 20-718

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Poznan, 60-354

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Poznan, 60-589

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Radom, 26-600

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Warsaw, 00-124

Poland

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Warsaw, 02-507

Poland

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Warsaw, 02-758

Poland

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Al-Ahsa, 36428

Saudi Arabia

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Dammam, 31444

Saudi Arabia

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Jeddah, 22384

Saudi Arabia

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Khobar, 31952

Saudi Arabia

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Riyadh, 11462

Saudi Arabia

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Riyadh, 12713

Saudi Arabia

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Bellville, 7530

South Africa

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Bloemfontein, 9301

South Africa

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Cape Town, 7500

South Africa

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Cape Town, 7764

South Africa

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Chatsworth, 4092

South Africa

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Claremont, 7708

South Africa

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Durban, 4091

South Africa

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eMkhomazi, 4170

South Africa

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Johannesburg, 1827

South Africa

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Johannesburg, 2113

South Africa

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Midrand, 1685

South Africa

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Wentworth, 4032

South Africa

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Busan, 49201

South Korea

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Busan, 49241

South Korea

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Daegu, 42415

South Korea

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Goyang-si, 13620

South Korea

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Gyeonggi-do, 13620

South Korea

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Incheon, 21565

South Korea

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Jongno-gu, 110-746

South Korea

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Seoul, 02447

South Korea

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Seoul, 120-752

South Korea

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Suwon, 443-721

South Korea

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A Coruña, 15006

Spain

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Almería, 04009

Spain

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Badalona, 08916

Spain

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Barcelona, 08036

Spain

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Barcelona, 08041

Spain

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Barcelona, 8035

Spain

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León, 24008

Spain

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Madrid, 28006

Spain

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Santander, 39008

Spain

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Santiago de Compostela, 15706

Spain

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Seville, 41003

Spain

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Seville, 41013

Spain

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Seville, 41950

Spain

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Tarragona, 43007

Spain

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Valencia, 46014

Spain

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Changhua, 500

Taiwan

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Kaohsiung City, 807

Taiwan

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Taichung, 402

Taiwan

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Taichung, 40447

Taiwan

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Taichung, 40705

Taiwan

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Taichung, 433004

Taiwan

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Tainan, 704

Taiwan

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Tainan County, 71044

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 110

Taiwan

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Adana, 01060

Turkey (Türkiye)

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Adana, 01120

Turkey (Türkiye)

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Adapazarı, 54290

Turkey (Türkiye)

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Ankara, 06530

Turkey (Türkiye)

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Ankara, 5000

Turkey (Türkiye)

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Ankara, 6230

Turkey (Türkiye)

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Antalya, 07059

Turkey (Türkiye)

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Istanbul, 34098

Turkey (Türkiye)

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Istanbul, 34384

Turkey (Türkiye)

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Istanbul, 34722

Turkey (Türkiye)

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Ashton-under-Lyne, OL6 6EW

United Kingdom

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Blackpool, FY3 7EN

United Kingdom

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Chesterfield, S40 4AA

United Kingdom

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Corby, NN17 2UR

United Kingdom

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Ely, CB7 5JD

United Kingdom

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Glasgow, G51 4TF

United Kingdom

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Hounslow, TW3 3LN

United Kingdom

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Leicester, Le5 4PW

United Kingdom

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Metropolitan Borough of Wirral, CH48 5AA

United Kingdom

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Poole, BH16 5PW

United Kingdom

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Rotherham, S65 1DA

United Kingdom

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Stowmarket, IP142SY

United Kingdom

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Wansford, PE8 6PL

United Kingdom

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Witney, OX28 6JS

United Kingdom

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Yate, BS37 4AX

United Kingdom