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

Recruiting · NCT07662044 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

DapagliflozinDapagliflozin-matched placeboElecoglipronElecoglipron-matched placebo

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 17 US states.

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 - Adana, Turkey (Türkiye)
Research Site - Amagasaki-shi, Japan
Research Site - Ankara, Turkey (Türkiye)
Research Site - Ankara, Turkey (Türkiye)
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Athens, Greece
Research Site - Baotou, China
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Binzhou, China
Research Site - Brackenfell, South Africa
Research Site - Bratislava, Slovakia
Research Site - Bratislava, Slovakia
Research Site - Budapest, Hungary
Research Site - Budapest, Hungary
Research Site - Budapest, Hungary
Research Site - Buenos Aires, Argentina
Research Site - Bursa, Turkey (Türkiye)
Research Site - CABA, Argentina
Research Site - Caba, Argentina
Research Site - Cangzhou, China
Research Site - Cape Town, South Africa
Research Site - Cape Town, South Africa
Research Site - Changhua, Taiwan
Research Site - Changsha, China
Research Site - Chengdu, China
Research Site - Chiba, Japan
Research Site - Chitose-shi, Japan
Research Site - Chūōku, Japan

Showing 60 of 149 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →