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NCT07662044PHASE3Recruiting

A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

AstraZeneca

Start Date

7/6/2026

Completion Date

7/14/2028

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening * T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * Body mass index (BMI) of ≥ 23 kg/m2 at screening * Stable body weight (self-reported or documented) for 90 days prior to screening Exclusion Criteria: * Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma * Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema * Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying * History of acute or chronic pancreatitis * Severe congestive heart failure (New York Heart Association IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Interventions

DRUG

Elecoglipron

DRUG

Dapagliflozin

DRUG

Elecoglipron-matched placebo

DRUG

Dapagliflozin-matched placebo

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Conditions

Type 2 Diabetes Mellitus

Locations

Research Site

Birmingham, Alabama 35233

United States

Research Site

Daphne, Alabama 36526

United States

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Lomita, California 90717

United States

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Los Alamitos, California 90720

United States

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San Diego, California 92111

United States

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Walnut Creek, California 94598

United States

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Englewood, Colorado 80110

United States

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Bridgeport, Connecticut 06606

United States

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Jacksonville, Florida 32256

United States

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Orlando, Florida 32801

United States

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Conyers, Georgia 30094

United States

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Decatur, Georgia 30030

United States

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Hinesville, Georgia 31313

United States

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El Dorado, Kansas 67042

United States

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Newton, Kansas 67114

United States

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Lexington, Kentucky 40509

United States

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Covington, Louisiana 70433

United States

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Bowie, Maryland 20715

United States

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Southfield, Michigan 48075

United States

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Kansas City, Missouri 64111

United States

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St Louis, Missouri 63141

United States

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Las Vegas, Nevada 89119

United States

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Anderson, South Carolina 29621

United States

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Knoxville, Tennessee 37909

United States

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Fort Worth, Texas 76135

United States

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Irving, Texas 75061

United States

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Renton, Washington 98057

United States

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Buenos Aires, C1425AGC

Argentina

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CABA, C1120AAC

Argentina

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Caba, C1128AAF

Argentina

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Ciudad de Buenos Aires, C1094AAD

Argentina

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Mar del Plata, B7600GNY

Argentina

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San Nicolás, B2900DMH

Argentina

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San Vicente, 5006

Argentina

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Santa Fe, S3000FWO

Argentina

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Baotou, 014030

China

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Binzhou, 256606

China

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Cangzhou, 061002

China

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Changsha, 430033

China

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Chengdu, 610081

China

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Ganzhou, 341099

China

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Haikou, 570208

China

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Hangzhou, 310006

China

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Huangshi, 435000

China

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Huzhou, 313003

China

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Jinan, 250013

China

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Jinzhou, 121002

China

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Lanzhou, 730000

China

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Lianyungang, 222023

China

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Liaocheng, 252000

China

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Liuzhou, 545006

China

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Loudi, 417099

China

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Luoyang, 471001

China

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Luoyang, 471003

China

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Nanchang, 330006

China

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Nanjing, 2100008

China

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Nanjing, 211100

China

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Nanyang, 473000

China

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Ningbo, 315010

China

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Panjin, 124000

China

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Qingdao, 266035

China

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Sanmenxia, 472000

China

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Shanghai, 200040

China

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Suining Shi, 629000

China

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Tonghua, 134000

China

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Xi'an, 710077

China

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Xiangtan, 411100

China

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Xuancheng, 242000

China

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Yibin, 610500

China

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Yichang, 443003

China

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Yuncheng, 044099

China

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Zhengzhou, 450002

China

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Zhengzhou, 450012

China

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Zhenjiang, 212002

China

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Gandrup, 9362

Denmark

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Herlev, 2730

Denmark

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Hillerød, 3400

Denmark

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Hvidovre, 2650

Denmark

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Athens, 10676

Greece

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Athens, 11526

Greece

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Athens, 12131

Greece

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Athens, 15125

Greece

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Heraklion, 71500

Greece

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Piraeus, 18454

Greece

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Thessaloniki, 54636

Greece

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Thessaloniki, 57001

Greece

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Thessaloniki, 57010

Greece

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Budapest, 1027

Hungary

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Budapest, 1036

Hungary

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Budapest, 1138

Hungary

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Debrecen, 4032

Hungary

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Dunaújváros, 2400

Hungary

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Szeged, 6725

Hungary

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Szolnok, 5000

Hungary

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Amagasaki-shi, 660-8550

Japan

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Chiba, 261-0004

Japan

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Chitose-shi, 066-0032

Japan

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Chūōku, 1040031

Japan

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Koga-shi, 306-0232

Japan

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Minatoku, 105-0004

Japan

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Okayama, 701-1192

Japan

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Oyama-shi, 323-0022

Japan

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Shinjuku-ku, 169-0072

Japan

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Zentsuji-shi, 765-0071

Japan

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Bratislava, 81108

Slovakia

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Bratislava, 831 03

Slovakia

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Košice, 04001

Slovakia

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Martin, 036 01

Slovakia

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Námestovo, 02901

Slovakia

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Poprad, 05845

Slovakia

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Rožňava, 048 01

Slovakia

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Brackenfell, 7560

South Africa

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Cape Town, 7500

South Africa

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Cape Town, 7570

South Africa

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Claremont, 7708

South Africa

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Durban, 4093

South Africa

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eMkhomazi, 4170

South Africa

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Johannesburg, 1827

South Africa

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KwaDukuza, 4449

South Africa

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Paarl, 7646

South Africa

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Pretoria, 2

South Africa

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Jongno-gu, 110-746

South Korea

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Seongnam-si, 463-712

South Korea

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Seoul, 03080

South Korea

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Seoul, 5505

South Korea

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Barcelona, 08016

Spain

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Barcelona, 08020

Spain

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Barcelona, 08035

Spain

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Barcelona, 08930

Spain

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Figueres, 17600

Spain

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Seville, 41003

Spain

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Seville, 41950

Spain

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Changhua, 500

Taiwan

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 813

Taiwan

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New Taipei City, 220

Taiwan

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Taichung, 40201

Taiwan

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Taichung, 40705

Taiwan

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Taichung, 433004

Taiwan

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Tainan, 70403

Taiwan

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Tainan County, 71044

Taiwan

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Taipei, 10002

Taiwan

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Adana, 01060

Turkey (Türkiye)

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Ankara, 06530

Turkey (Türkiye)

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Ankara, 06560

Turkey (Türkiye)

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Bursa, 16310

Turkey (Türkiye)

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Izmir, 35340

Turkey (Türkiye)

Research Site

Kayseri, 38039

Turkey (Türkiye)

Research Site

Samsun, 55139

Turkey (Türkiye)