Trial comparing treatments for Chronic Kidney Disease
Official title A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease.
ClinicalTrials.gov ID: NCT07753993
What this study is testing
What is Elecoglipron?
Elecoglipron is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Montgomery, Alabama, United States
- Sheffield, Alabama, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Surprise, Arizona, United States
- Little Rock, Arkansas, United States
- Chula Vista, California, United States
- Concord, California, United States
- Daly City, California, United States
- Fremont, California, United States
- Huntington Beach, California, United States
- Huntington Park, California, United States
- Lomita, California, United States
- National City, California, United States
- Northridge, California, United States
- Rolling Hills Estates, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
+ 538 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Montgomery, Alabama, United States; Sheffield, Alabama, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States; Surprise, Arizona, United States and 552 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.