RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07662044

Registry updated: 2026-08-31

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

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 — Birmingham, Alabama, United States
Research Site — Daphne, Alabama, United States
Research Site — Lomita, California, United States
Research Site — Los Alamitos, California, United States
Research Site — San Diego, California, United States
Research Site — Walnut Creek, California, United States
Research Site — Englewood, Colorado, United States
Research Site — Bridgeport, Connecticut, United States
Research Site — Jacksonville, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Conyers, Georgia, United States
Research Site — Decatur, Georgia, United States
Research Site — Hinesville, Georgia, United States
Research Site — El Dorado, Kansas, United States
Research Site — Newton, Kansas, United States
Research Site — Lexington, Kentucky, United States
Research Site — Covington, Louisiana, United States
Research Site — Bowie, Maryland, United States
Research Site — Southfield, Michigan, United States
Research Site — Kansas City, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Las Vegas, Nevada, United States
Research Site — Anderson, South Carolina, United States
Research Site — Knoxville, Tennessee, United States
Research Site — Fort Worth, Texas, United States
Research Site — Irving, Texas, United States
Research Site — Renton, Washington, United States
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 — San Nicolás, Argentina
Research Site — San Vicente, Argentina
Research Site — Santa Fe, Argentina
Research Site — Baotou, China
Research Site — Binzhou, China
Research Site — Cangzhou, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Ganzhou, China
Research Site — Haikou, China
Research Site — Hangzhou, China
Research Site — Huangshi, China
Research Site — Huzhou, China
Research Site — Jinan, China
Research Site — Jinzhou, China
Research Site — Lanzhou, China
Research Site — Lianyungang, China
Research Site — Liaocheng, China
Research Site — Liuzhou, China
Research Site — Loudi, China
Research Site — Luoyang, China
Research Site — Luoyang, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nanjing, China
Research Site — Nanyang, China
Research Site — Ningbo, China
Research Site — Panjin, China
Research Site — Qingdao, China
Research Site — Sanmenxia, China
Research Site — Shanghai, China
Research Site — Suining Shi, China
Research Site — Tonghua, China
Research Site — Xi'an, China
Research Site — Xiangtan, China
Research Site — Xuancheng, China
Research Site — Yibin, China
Research Site — Yichang, China
Research Site — Yuncheng, China
Research Site — Zhengzhou, China
Research Site — Zhengzhou, China
Research Site — Zhenjiang, China
Research Site — Gandrup, Denmark
Research Site — Herlev, Denmark
Research Site — Hillerød, Denmark
Research Site — Hvidovre, Denmark
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Heraklion, Greece
Research Site — Piraeus, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Thessaloniki, Greece
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Dunaújváros, Hungary
Research Site — Szeged, Hungary
Research Site — Szolnok, Hungary
Research Site — Amagasaki-shi, Japan
Research Site — Chiba, Japan
Research Site — Chitose-shi, Japan
Research Site — Chūōku, Japan
Research Site — Koga-shi, Japan
Research Site — Minatoku, Japan
Research Site — Okayama, Japan
Research Site — Oyama-shi, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Zentsuji-shi, Japan
Research Site — Bratislava, Slovakia
Research Site — Bratislava, Slovakia
Research Site — Košice, Slovakia
Research Site — Martin, Slovakia
Research Site — Námestovo, Slovakia
Research Site — Poprad, Slovakia
Research Site — Rožňava, Slovakia
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 — 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 — Jongno-gu, South Korea
Research Site — Seongnam-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Figueres, Spain
Research Site — Seville, Spain
Research Site — Seville, Spain
Research Site — Changhua, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung 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 — Adana, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Bursa, Turkey (Türkiye)
Research Site — Izmir, Turkey (Türkiye)
Research Site — Kayseri, Turkey (Türkiye)
Research Site — Samsun, Turkey (Türkiye)

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment