EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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Placebo matching Elecoglipron tablet once daily

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.

A study to investigate outcomes with elecoglipron compared with placebo in adult participants with chronic kidney disease.

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A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

Time to the first occurrence of any component of this composite:
- ≥ 50% sustained decline in eGFR
- ESKD defined as:
Sustained eGFR < 10 mL/min/1.73 m2, or
Chronic dialysis treatment, or
Receiving a renal transplant
- All-cause mortality

Time to the first occurrence of any component of this composite:
- ≥ 50% sustained decline in eGFR
- ESKD defined as:
Sustained eGFR < 10 mL/min/1.73 m2, or
Chronic dialysis treatment, or
Receiving a renal transplant
- CV and renal death

Time to the first occurrence of any component of this composite:
- All-cause mortality
- MI
- Stroke

Time to the first occurrence of any component of this composite:
- CV and renal death
- MI
- Stroke

Time to the first occurrence of any component of this composite:
- ≥ 50% sustained decline in eGFR
- ESKD defined as:
Sustained eGFR < 10 mL/min/1.73 m2, or
Chronic dialysis treatment, or
Receiving a renal transplant
- Renal death

Time to the first occurrence of any component of this composite:
- CV death
- HF hospitalizations (hHF)

Time to first occurrence of any component of this composite:
- CV death
- MI
- Stroke
- HF hospitalizations (hHF)

Arms	Assigned Interventions
Experimental: Elecoglipron Elecoglipron tablet once daily	Drug: Elecoglipron Elicoglipron tablet
Active Comparator: Placebo Placebo matching Elecoglipron tablet once daily	Drug: Placebo Placebo tablet

A study to investigate outcomes with elecoglipron compared with placebo in adult participants with chronic kidney disease. - Elevate-CKD

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