A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin

Recruiting · NCT07662135 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

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 for at least 90 days prior to screening
On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
HbA1c value:
On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
Impaired renal function
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 19 US states.

Research Site - Sun City, Arizona, United States
Research Site - Surprise, Arizona, United States
Research Site - Concord, California, United States
Research Site - Sacramento, California, United States
Research Site - Victorville, California, United States
Research Site - Fleming Island, Florida, United States
Research Site - Lauderdale Lakes, Florida, United States
Research Site - Leesburg, Florida, United States
Research Site - Miami Lakes, Florida, United States
Research Site - Ocoee, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Chicago, Illinois, United States
Research Site - Braintree, Massachusetts, United States
Research Site - New Bedford, Massachusetts, United States
Research Site - Worcester, Massachusetts, United States
Research Site - Saint Joseph, Michigan, United States
Research Site - Saint Paul, Minnesota, United States
Research Site - Kansas City, Missouri, United States
Research Site - Omaha, Nebraska, United States
Research Site - Las Vegas, Nevada, United States
Research Site - Albuquerque, New Mexico, United States
Research Site - The Bronx, New York, United States
Research Site - Kinston, North Carolina, United States
Research Site - Raleigh, North Carolina, United States
Research Site - Winston-Salem, North Carolina, United States
Research Site - Cincinnati, Ohio, United States
Research Site - East Providence, Rhode Island, United States
Research Site - Gaffney, South Carolina, United States
Research Site - Greenville, South Carolina, United States
Research Site - San Antonio, Texas, United States
Research Site - San Antonio, Texas, United States
Research Site - Ogden, Utah, United States
Research Site - Arlington, Virginia, United States
Research Site - Aarhus N, Denmark
Research Site - Adana, Turkey (Türkiye)
Research Site - Aligarh, India
Research Site - Ankara, Turkey (Türkiye)
Research Site - Antalya, Turkey (Türkiye)
Research Site - Bad Oeynhausen, Germany
Research Site - Bakırköy, Turkey (Türkiye)
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Barcelona, Spain
Research Site - Batu Caves, Malaysia
Research Site - Belagavi, India
Research Site - Belgavi, India
Research Site - Berlin, Germany
Research Site - Binzhou, China
Research Site - Blackpool, United Kingdom
Research Site - Brandenburg an der Havel, Germany
Research Site - Calicut, India
Research Site - Changsha, China
Research Site - Chemnitz, Germany
Research Site - Chengdu, China
Research Site - Chennai, India
Research Site - Chennai, India
Research Site - Chiang Mai, Thailand
Research Site - Chigasaki-shi, Japan
Research Site - Chihuahua City, Mexico
Research Site - Chikushino-shi, Japan

Showing 60 of 186 listed sites. See the official record for the complete list.

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