RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07662109

Registry updated: 2026-08-31

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Description

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

Interventions

Elecoglipron (Drug)
Elecoglipron is administered orally once daily.
Dapagliflozin (Drug)
Dapagliflozin administered orally once daily.
Elecoglipron-matched placebo (Drug)
A placebo matching elecoglipron administered orally once daily.
Dapagliflozin-matched placebo (Drug)
A placebo matching dapagliflozin administered orally once daily.

Eligibility criteria

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

Conditions

Type 2 Diabetes Mellitus

Locations

Research Site — Huntsville, Alabama, United States
Research Site — Mobile, Alabama, United States
Research Site — Sheffield, Alabama, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Bakersfield, California, United States
Research Site — Los Angeles, California, United States
Research Site — Ontario, California, United States
Research Site — Lake City, Florida, United States
Research Site — Lakeland, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Skokie, Illinois, United States
Research Site — Evansville, Indiana, United States
Research Site — Sioux City, Iowa, United States
Research Site — Zachary, Louisiana, United States
Research Site — Annapolis, Maryland, United States
Research Site — Lutherville-Timonium, Maryland, United States
Research Site — Oxon Hill, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Troy, Michigan, United States
Research Site — Ridgeland, Mississippi, United States
Research Site — Elkhorn, Nebraska, United States
Research Site — Albuquerque, New Mexico, United States
Research Site — Brooklyn, New York, United States
Research Site — Raleigh, North Carolina, United States
Research Site — Beachwood, Ohio, United States
Research Site — Maumee, Ohio, United States
Research Site — Norman, Oklahoma, United States
Research Site — Kingsport, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Dallas, Texas, United States
Research Site — McKinney, Texas, United States
Research Site — Paris, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — South Jordan, Utah, United States
Research Site — Arlington, Virginia, United States
Research Site — Newport News, Virginia, United States
Research Site — Redmond, Washington, United States
Research Site — Kingwood, West Virginia, United States
Research Site — Buenos Aires, Argentina
Research Site — Buenos Aires, Argentina
Research Site — CABA, Argentina
Research Site — Caba, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — Mar del Plata, Argentina
Research Site — Rosario, Argentina
Research Site — San Nicolás, Argentina
Research Site — San Vicente, Argentina
Research Site — Barretos, Brazil
Research Site — Brasília, Brazil
Research Site — Campinas, Brazil
Research Site — Curitiba, Brazil
Research Site — Fortaleza, Brazil
Research Site — Natal, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — São José dos Campos, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Baotou, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changde, China
Research Site — Changsha, China
Research Site — Changzhou, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chenzhou, China
Research Site — Chifeng, China
Research Site — Hangzhou, China
Research Site — Hefei, China
Research Site — Huai'an, China
Research Site — Jinan, China
Research Site — Jincheng, China
Research Site — Jining, China
Research Site — Jinzhou Shi, China
Research Site — Kaifeng, China
Research Site — Langfang, China
Research Site — Liangyugang, China
Research Site — Luoyang, China
Research Site — Meihekou, China
Research Site — Nanjing, China
Research Site — Nantong, China
Research Site — Nanyang, China
Research Site — Pinggu, China
Research Site — Pingxiang, China
Research Site — Sanya, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shantou, China
Research Site — Shenyang, China
Research Site — Shenyang, China
Research Site — Shijiazhuang, China
Research Site — Shijiazhuang, China
Research Site — Tianjin, China
Research Site — Wuhan, China
Research Site — Wuhu, China
Research Site — Xi'an, China
Research Site — Xiangyang, China
Research Site — Xianyang, China
Research Site — Xuzhou, China
Research Site — Xuzhou, China
Research Site — Yan’an, China
Research Site — Yueyang, China
Research Site — Zhumadian, China
Research Site — Zibo, China
Research Site — Hradec Králové, Czechia
Research Site — Humpolec, Czechia
Research Site — Jílové u Prahy, Czechia
Research Site — Ostrava, Czechia
Research Site — Prague, Czechia
Research Site — Prague, Czechia
Research Site — Prague, Czechia
Research Site — Příbram, Czechia
Research Site — Aarhus N, Denmark
Research Site — Esbjerg, Denmark
Research Site — Gandrup, Denmark
Research Site — Herlev, Denmark
Research Site — Hillerød, Denmark
Research Site — Hvidovre, Denmark
Research Site — Odense, Denmark
Research Site — Berlin, Germany
Research Site — Cologne, Germany
Research Site — Damme, Germany
Research Site — Deggingen, Germany
Research Site — Duisburg, Germany
Research Site — Essen, Germany
Research Site — Falkensee, Germany
Research Site — Frankfurt, Germany
Research Site — Hamburg, Germany
Research Site — Leipzig, Germany
Research Site — Münster, Germany
Research Site — Nittendorf, Germany
Research Site — Pohlheim, Germany
Research Site — Villingen-Schwenningen, Germany
Research Site — Wallerfing, Germany
Research Site — Weinheim, Germany
Research Site — Alexandroupoli, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Ioannina, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Salgótarján, Hungary
Research Site — Szeged, Hungary
Research Site — Szolnok, Hungary
Research Site — Zalaegerszeg, Hungary
Research Site — Bangalore, India
Research Site — Belagavi, India
Research Site — Belagavi, India
Research Site — Calicut, India
Research Site — Chennai, India
Research Site — Coimbatore, India
Research Site — Guwahati, India
Research Site — Indore, India
Research Site — Jaipur, India
Research Site — Kochi, India
Research Site — Kochi, India
Research Site — Lucknow, India
Research Site — Madurai, India
Research Site — Mumbai, India
Research Site — Nagpur, India
Research Site — New Delhi, India
Research Site — Thiruvananthapuram, India
Research Site — Chūōku, Japan
Research Site — Hachioji-shi, Japan
Research Site — Ichikawa-shi, Japan
Research Site — Kishiwada-shi, Japan
Research Site — Meguro-ku, Japan
Research Site — Mito, Japan
Research Site — Sapporo, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Yamato-shi, Japan
Research Site — Alor Star, Malaysia
Research Site — Ipoh, Malaysia
Research Site — Kangar, Malaysia
Research Site — Kuala Lumpur, Malaysia
Research Site — Sarawak Miri, Malaysia
Research Site — Seremban, Malaysia
Research Site — Seri Manjung, Malaysia
Research Site — Cuernavaca, Mexico
Research Site — Bialystok, Poland
Research Site — Częstochowa, Poland
Research Site — Kielce, Poland
Research Site — Lodz, Poland
Research Site — Lublin, Poland
Research Site — Poznan, Poland
Research Site — Radom, Poland
Research Site — Warsaw, Poland
Research Site — Warsaw, Poland
Research Site — San Juan, Puerto Rico
Research Site — Brackenfell, South Africa
Research Site — Cape Town, South Africa
Research Site — Cape Town, South Africa
Research Site — Claremont, South Africa
Research Site — Durban, South Africa
Research Site — Durban, South Africa
Research Site — eMkhomazi, South Africa
Research Site — Johannesburg, South Africa
Research Site — KwaDukuza, South Africa
Research Site — Paarl, South Africa
Research Site — Pretoria, South Africa
Research Site — Goyang-si, South Korea
Research Site — Guri-si, South Korea
Research Site — Gwangju, South Korea
Research Site — Gyeonggi-do, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Yangsan, South Korea
Research Site — Changhua, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — New Taipei City, Taiwan
Research Site — New Taipei City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Tainan County, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Bangkok, Thailand
Research Site — Banphaeo, Thailand
Research Site — Changwat Sara Buri, Thailand
Research Site — Khlong Luang, Thailand
Research Site — Khon Kaen, Thailand
Research Site — Muang, Thailand
Research Site — Mueang, Thailand
Research Site — Ratchathewi, Thailand
Research Site — Ankara, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Gaziantep, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Konya, Turkey (Türkiye)
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Lviv, Ukraine
Research Site — Lviv, Ukraine
Research Site — Uzhhorod, Ukraine
Research Site — Uzhhorod, Ukraine
Research Site — Vinnytsia, Ukraine
Research Site — Blackburn, United Kingdom
Research Site — Dundee, United Kingdom
Research Site — Guisborough, United Kingdom
Research Site — Nantwich, United Kingdom
Research Site — Rotherham, United Kingdom
Research Site — Thetford, United Kingdom
Research Site — Weston-super-Mare, United Kingdom
Research Site — Witney, United Kingdom
Research Site — Woodbridge, United Kingdom
Research Site — Yate, United Kingdom
Research Site — Hanoi, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Hochiminh City, Vietnam
Research Site — Hochiminh, Vietnam
Research Site — Hồ Chí Minh, Vietnam
Research Site — Huế, Vietnam
Research Site — Rach Gia, Vietnam

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