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Clinical Trials in the UK / NCT07662135
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-07-06
Last updated
2026-09-02

Condition(s) studied

Type 2 Diabetes MellitusType 2 Diabetes With Chronic Kidney Disease

Investigational drug(s) / intervention(s)

ElecoglipronPlacebo

Elecoglipron: Elecoglipron is administered orally once daily.

Placebo: Placebo is administered orally once daily.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (186)

FacilityCityRegionStatus
Research Site Sun City Arizona Not Yet Recruiting
Research Site Surprise Arizona Not Yet Recruiting
Research Site Concord California Not Yet Recruiting
Research Site Sacramento California Recruiting
Research Site Victorville California Not Yet Recruiting
Research Site Fleming Island Florida Not Yet Recruiting
Research Site Lauderdale Lakes Florida Not Yet Recruiting
Research Site Leesburg Florida Not Yet Recruiting
Research Site Miami Lakes Florida Recruiting
Research Site Ocoee Florida Recruiting
Research Site Orlando Florida Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Braintree Massachusetts Not Yet Recruiting
Research Site New Bedford Massachusetts Not Yet Recruiting
Research Site Worcester Massachusetts Not Yet Recruiting
Research Site Saint Joseph Michigan Suspended
Research Site Saint Paul Minnesota Not Yet Recruiting
Research Site Kansas City Missouri Recruiting
Research Site Omaha Nebraska Not Yet Recruiting
Research Site Las Vegas Nevada Not Yet Recruiting
Research Site Albuquerque New Mexico Recruiting
Research Site The Bronx New York Not Yet Recruiting
Research Site Kinston North Carolina Not Yet Recruiting
Research Site Raleigh North Carolina Recruiting
Research Site Winston-Salem North Carolina Not Yet Recruiting
Research Site Cincinnati Ohio Not Yet Recruiting
Research Site East Providence Rhode Island Not Yet Recruiting
Research Site Gaffney South Carolina Recruiting
Research Site Greenville South Carolina Not Yet Recruiting
Research Site San Antonio Texas Suspended
Research Site San Antonio Texas Not Yet Recruiting
Research Site Ogden Utah Not Yet Recruiting
Research Site Arlington Virginia Suspended
Research Site Dupnitsa Bulgaria Not Yet Recruiting
Research Site Haskovo Bulgaria Not Yet Recruiting
Research Site Kyustendil Bulgaria Not Yet Recruiting
Research Site Pleven Bulgaria Not Yet Recruiting
Research Site Plovdiv Bulgaria Not Yet Recruiting
Research Site Rousse Bulgaria Not Yet Recruiting
Research Site Stara Zagora Bulgaria Not Yet Recruiting

+ 146 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07662135 on ClinicalTrials.gov ↗ ← All trials in the UK