A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.

Recruiting · NCT07753993 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.

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

Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.

Exclusion criteria

BMI \<23 kg/m² at screening
History of type 1 diabetes mellitus
HbA1c ≥10% (86 mmol/mol) at screening
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 hypoglycemia unawareness
Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
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
History/family history (first degree) of medullary thyroid cancer or MEN2

Where it is running

60 locations listed across 33 US states.

Research Site - Huntsville, Alabama, United States
Research Site - Montgomery, Alabama, United States
Research Site - Sheffield, Alabama, United States
Research Site - Peoria, Arizona, United States
Research Site - Phoenix, Arizona, United States
Research Site - Surprise, Arizona, United States
Research Site - Little Rock, Arkansas, United States
Research Site - Chula Vista, California, United States
Research Site - Concord, California, United States
Research Site - Daly City, California, United States
Research Site - Fremont, California, United States
Research Site - Huntington Beach, California, United States
Research Site - Huntington Park, California, United States
Research Site - Lomita, California, United States
Research Site - National City, California, United States
Research Site - Northridge, California, United States
Research Site - Northridge, California, United States
Research Site - Rolling Hills Estates, California, United States
Research Site - San Diego, California, United States
Research Site - San Francisco, California, United States
Research Site - San Mateo, California, United States
Research Site - Tarzana, California, United States
Research Site - Arvada, Colorado, United States
Research Site - Denver, Colorado, United States
Research Site - Hartford, Connecticut, United States
Research Site - Middlebury, Connecticut, United States
Research Site - Waterbury, Connecticut, United States
Research Site - Boca Raton, Florida, United States
Research Site - Boynton Beach, Florida, United States
Research Site - Cutler Bay, Florida, United States
Research Site - Fort Lauderdale, Florida, United States
Research Site - Hollywood, Florida, United States
Research Site - Jacksonville Beach, Florida, United States
Research Site - Jensen Beach, Florida, United States
Research Site - Lauderdale Lakes, Florida, United States
Research Site - Longwood, Florida, United States
Research Site - Melbourne, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Ocoee, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Pensacola, Florida, United States
Research Site - Port Charlotte, Florida, United States
Research Site - Riverview, Florida, United States
Research Site - Austell, Georgia, United States
Research Site - Columbus, Georgia, United States
Research Site - East Point, Georgia, United States
Research Site - Tucker, Georgia, United States
Research Site - Champaign, Illinois, United States
Research Site - Chicago, Illinois, United States
Research Site - Chicago, Illinois, United States
Research Site - Rockford, Illinois, United States
Research Site - Tinley Park, Illinois, United States
Research Site - Ames, Iowa, United States
Research Site - Topeka, Kansas, United States
Research Site - Beltsville, Maryland, United States
Research Site - Boston, Massachusetts, United States
Research Site - New Bedford, Massachusetts, United States
Research Site - Detroit, Michigan, United States
Research Site - Flint, Michigan, United States

Showing 60 of 715 listed sites. See the official record for the complete list.

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