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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
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

NCT07662135

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease

Interventions: Elecoglipron, Placebo

Countries: United States, Bulgaria, China, Denmark, Germany, India, Japan, Malaysia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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:

  1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
  2. 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
Locations (169)
  • Peoria, Arizona, United States
  • Surprise, Arizona, United States
  • Concord, California, United States
  • Sacramento, California, United States
  • Victorville, California, United States
  • Fleming Island, Florida, United States
  • Lauderdale Lakes, Florida, United States
  • Leesburg, Florida, United States
  • Miami Lakes, Florida, United States
  • Ocoee, Florida, United States
  • Orlando, Florida, United States
  • Braintree, Massachusetts, United States
  • New Bedford, Massachusetts, United States
  • Saint Joseph, Michigan, United States
  • Saint Paul, Minnesota, United States
  • Kansas City, Missouri, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Albuquerque, New Mexico, United States
  • The Bronx, New York, United States
  • Kinston, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • East Providence, Rhode Island, United States
  • Gaffney, South Carolina, United States
  • Greenville, South Carolina, United States
  • San Antonio, Texas, United States
  • Ogden, Utah, United States
  • Arlington, Virginia, United States
  • + 139 more on CT.gov