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Clinical Trials List

Protocol NumberD7265C00001
NCT Number(ClinicalTrials.gov Identfier)NCT07753993
Not yet recruiting

2026-06-01 - 2031-06-30

Phase III

Recruiting14

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)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/08

Investigators and Locations

Principal Investigator Ji-Tseng Fang Division of Nephrology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator VIN-CENT Wu Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Chin Lee Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王怡寬 Division of Nephrology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 杜思德 Division of Endocrinology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YUNG-HO HSU Division of Nephrology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾牧圻 Division of Nephrology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張家築 Division of Nephrology
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 江珠影 Division of Endocrinology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王憲奕 Division of Nephrology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Hsien Chen Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳勝文 Division of Nephrology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 杜奕德 Division of Nephrology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Junne-Ming Sung
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Kidney Disease

Objectives

本試驗的目的，是研究 elecoglipron 相較於安慰劑在患有 CKD、伴隨和未伴隨 T2DM、 接受 SGLT2i（dapagliflozin 每日 10 mg）作為CKD之 GDMT背景下 和其他 SoC 治療參與者的治療結果。

Test Drug

錠劑
膜衣錠

Active Ingredient

Elecoglipron
DAPAGLIFLOZIN

Dosage Form

110
116

Dosage

5 mg, 15 mg, 20 mg, 45 mg
10mg

Endpoints

首次出現以下任一複合風險組成事件前所經時間：
•eGFR 持續降低 ≥ 50%
•ESKD 定義為：
eGFR 持續 < 10 mL/min/1.73 m2，或
慢性透析治療，或
接受腎臟移植
•全因死亡率

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    260 participants

  • Global

    7000 participants

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