Chronic Kidney Disease study: Elecoglipron
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, 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
- The study will find out whether elecoglipron improves health outcomes for people with chronic kidney disease, with or without type 2 diabetes, who are already taking dapagliflozin and other standard kidney medicines.
- Who it's for
- Adults who have chronic kidney disease (some may also have type 2 diabetes) and are currently on dapagliflozin and usual kidney care.
- What's involved
- Participants will be randomly assigned to receive either elecoglipron or a placebo, without knowing which they get, and will continue their regular kidney treatments while attending study visits and undergoing required tests.
- 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 is enrolling
- Minneapolis, Minnesota, United States
- Arlington, Texas, United States
- South Salt Lake, Utah, United States
- Gosford, Australia
- Southport, Australia
- Toronto, Ontario, Canada
- Waterloo, Ontario, Canada
- Stuttgart, Germany
- Kamakura-shi, Japan
- Minokamo Shi, Japan
- Nagoya, Japan
- Taichung, Taiwan
- Taipei, Taiwan
- London, United Kingdom
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, but 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?
This study is enrolling now at Minneapolis, Minnesota, United States; Arlington, Texas, United States; South Salt Lake, Utah, United States; Gosford, Australia; Southport, Australia; Toronto, Ontario, Canada and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.