Clinical Trials List
Protocol NumberD7261C00004
Not yet recruiting
2026-06-01 - 2028-12-31
Phase III
Not yet recruiting1
A randomized, double-blind, parallel-group, phase 3 trial was conducted to evaluate the efficacy, safety, and tolerability of elecoglipron compared to placebo in adult patients with type 2 diabetes, impaired renal function, and receiving background treatment with dapagliflozin (Eluminate-4).
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/21
Investigators and Locations
Co-Principal Investigator
- FAN-CHI CHANG Division of Nephrology
- CHUN-FU LAI Division of Nephrology
- YI-TING HSIEH Division of Nephrology
- 陳怡婷 Division of Nephrology
- YU-HSIANG CHOU Division of Nephrology
- WEN-CHIH CHIANG Division of Nephrology
- - - Division of Nephrology
- 黃道民 Division of Nephrology
Co-Principal Investigator
- Li-Yee Hong Division of Nephrology
- 高芷華 Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
- YUNG-HO HSU Division of Nephrology
- 賴史忠 Division of Nephrology
- 林冠宏 Division of Nephrology
- Chia-Te Liao Division of Nephrology
- Yu-Wei Chen Division of Nephrology
- Mai-Szu Wu Division of Nephrology
Co-Principal Investigator
- 傅崇銘 Division of Nephrology
- Wen-Chin Lee Division of Nephrology
- CHIH-CHAO YANG Division of Nephrology
- 李岳庭 Division of Nephrology
- 黃鏘綺 Division of Nephrology
- 邱千華 Division of Nephrology
- 許淳惟 Division of Nephrology
- 蘇昱日 Division of Nephrology
- 姜威宇 Division of Nephrology
- 周嘉安 Division of Nephrology
Co-Principal Investigator
- 陳靜怡 Division of Nephrology
- Te-Chao Fang Division of Nephrology
- I-WEN WU Division of Nephrology
- Chih-Chin Kao Division of Nephrology
Principal Investigator
Ji-Tseng Fang
Co-Principal Investigator
- 林承緯 Division of Nephrology
- Chun-Hsiu Liu Division of Nephrology
- 吳欣旭 Division of Nephrology
- Chih-Shiang Chang Division of Nephrology
- Yung-Chang Chen Division of Nephrology
- 鄭昌錡 Division of Nephrology
- Jia-Hong Lin Division of Nephrology
- Guan-Hsing Chen Division of Nephrology
- 陳怡文 Division of Nephrology
- 范佩君 Division of Nephrology
- 王涵芸 Division of Nephrology
- Cheng-Chia Lee Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Type 2 diabetes
Objectives
This is a global, randomized, double-blind, parallel-group, multicenter, phase 3 trial designed to evaluate the efficacy, safety, and tolerability of elecoglipron compared to placebo in adult patients with type 2 diabetes mellitus (T2DM) who have poor lifestyle management and impaired renal function and are currently receiving or about to receive SGLT2i background therapy (dapagliflozin 10 mg) according to CKD GDMT and are receiving at most one stable dose of a hypoglycemic agent (metformin, SU, nateglinide, AGI, or basal or premixed insulin).
Test Drug
Dapagliflozin
Elecoglipron
Elecoglipron
Active Ingredient
Dapagliflozin
Elecoglipron
Elecoglipron
Dosage Form
Film-coated tablets
Tablets
Tablets
Dosage
10 mg
5 mg, 15 mg, 20 mg, 45 mg
5 mg, 15 mg, 20 mg, 45 mg
Endpoints
Evaluate the efficacy of elecoglipron 45 mg and elecoglipron 65 mg compared to placebo in the following aspects, in the context of background medication dapagliflozin 10 mg: glycemic control.
Inclution Criteria
Participants are eligible for inclusion in this trial only if they meet all of the following criteria:
Age: 1. Participants must be of legal age of consent and at least 18 years old when signing the participant consent form.
Participant Type and Disease Characteristics: 2. Participants must have been diagnosed with type 2 diabetes mellitus (T2DM) according to World Health Organization or local diagnostic criteria at least 90 days prior to the screening follow-up visit (first follow-up visit). 3. At least 90 days prior to the screening follow-up visit (first follow-up visit), a prescription must be issued according to local package inserts for a stable dose of a sodium-glucose cotransporter 2 inhibitor (SGTL2i) or never having received an SGTL2i, and in combination with at most one of the following treatments: metformin or sulfonylurea (SU) or nateglinide or alpha-glucosidase inhibitors (AGI) or basal or premixed insulin (with a maximum daily variation of no more than 20% in total insulin dose).
4. Glycated hemoglobin (HbA1C) values measured by the central laboratory at the screening follow-up visit (first follow-up visit):
(a) Received a stable dose of SGLT2i at the screening follow-up visit (first follow-up visit): ≥ 7.0% to ≤ 10.5% (53 to 91.3 mmol/mol).
(b) Never received SGLT2i at the screening follow-up visit (first follow-up visit): ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol). 5. Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) ≥ 20 to ≤ 60 mL/min/1.73 m² at the screening follow-up visit (first follow-up visit) (GFR estimated based on creatinine using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).
Weight
6. Body mass index (BMI) ≥ 23 kg/m² at the screening follow-up visit (first follow-up visit).
7. As determined by the trial administrator, stable weight (± 5% weight change) for 90 days prior to the screening follow-up visit (first follow-up visit) (self-reported or recorded) until the screening period.
Sex and Contraception/Barrier Requirements
8. Individuals designated as male and/or female at birth, including all gender identities.
Informed Consent
9. Able to sign a participant consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations set forth in this trial protocol.
10. Provide a signed and dated written ICF before conducting any necessary trial-specific procedures, specimen collection, and analysis.
Selective Genome Project Informed Consent
11. Provide a signed and dated selective genome project study information and participant consent form before collecting specimens used to support the selective genome project study. (Not applicable; Taiwan did not participate)
Age: 1. Participants must be of legal age of consent and at least 18 years old when signing the participant consent form.
Participant Type and Disease Characteristics: 2. Participants must have been diagnosed with type 2 diabetes mellitus (T2DM) according to World Health Organization or local diagnostic criteria at least 90 days prior to the screening follow-up visit (first follow-up visit). 3. At least 90 days prior to the screening follow-up visit (first follow-up visit), a prescription must be issued according to local package inserts for a stable dose of a sodium-glucose cotransporter 2 inhibitor (SGTL2i) or never having received an SGTL2i, and in combination with at most one of the following treatments: metformin or sulfonylurea (SU) or nateglinide or alpha-glucosidase inhibitors (AGI) or basal or premixed insulin (with a maximum daily variation of no more than 20% in total insulin dose).
4. Glycated hemoglobin (HbA1C) values measured by the central laboratory at the screening follow-up visit (first follow-up visit):
(a) Received a stable dose of SGLT2i at the screening follow-up visit (first follow-up visit): ≥ 7.0% to ≤ 10.5% (53 to 91.3 mmol/mol).
(b) Never received SGLT2i at the screening follow-up visit (first follow-up visit): ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol). 5. Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) ≥ 20 to ≤ 60 mL/min/1.73 m² at the screening follow-up visit (first follow-up visit) (GFR estimated based on creatinine using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).
Weight
6. Body mass index (BMI) ≥ 23 kg/m² at the screening follow-up visit (first follow-up visit).
7. As determined by the trial administrator, stable weight (± 5% weight change) for 90 days prior to the screening follow-up visit (first follow-up visit) (self-reported or recorded) until the screening period.
Sex and Contraception/Barrier Requirements
8. Individuals designated as male and/or female at birth, including all gender identities.
Informed Consent
9. Able to sign a participant consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations set forth in this trial protocol.
10. Provide a signed and dated written ICF before conducting any necessary trial-specific procedures, specimen collection, and analysis.
Selective Genome Project Informed Consent
11. Provide a signed and dated selective genome project study information and participant consent form before collecting specimens used to support the selective genome project study. (Not applicable; Taiwan did not participate)
Exclusion Criteria
Participants are ineligible to participate in the trial if they meet any of the following criteria:
Diabetes
1. Any of the following related medical histories or complications:
(a) Type 1 diabetes mellitus (T1DM), secondary diabetes (including congenital), or ketoacidosis or hyperosmolar coma occurring within 180 days prior to or during the screening follow-up visit (1st follow-up visit).
(b) Currently receiving or expected to receive treatment interventions for diabetic retinopathy and/or macular edema. To confirm participant eligibility, fundus photography or cycloplegic ophthalmoscopy will be performed by an ophthalmologist/optometrist according to the schedule of activities (SoA) or according to local practice.
(c) Having experienced one or more severe hypoglycemic events within 180 days prior to or during the screening follow-up visit (1st follow-up visit), defined as experiencing neurogenic hypoglycemia requiring assistance, or as determined by the trial administrator to have experienced involuntary hypoglycemia or poor recognition of hypoglycemic symptoms.
Weight
2. Any of the following conditions related to medical reasons or planned/previous weight changes:
(a) Received any prescription, over-the-counter, or herbal supplements for weight loss within 90 days prior to the screening follow-up visit (First Follow-up Visit) and up to the screening period.
(b) Received or planned (during the trial period) endoscopic or surgical weight loss procedures (e.g., bariatric surgery or implantation of a weight loss device [e.g., gastric balloon or duodenal barrier]). Exception: Subjects who have had an implanted weight loss device removed and whose weight is stable more than 180 days prior to the screening follow-up visit (First Follow-up Visit) (as described in inclusion criterion 7).
(c) Plans to initiate a targeted weight loss program during the trial period, in addition to lifestyle management as outlined in the trial protocol.
Gastrointestinal/Hepatic Disorders
3. Patients with known clinically significant conditions affecting the upper gastrointestinal (GI) tract (e.g., gastroparesis, gastric outlet obstruction, serious illness, or surgery) or those using any medication that affects gastric motility or gastric emptying (e.g., metoclopramide) that may interfere with the absorption or interpretation of the investigational drug's safety and tolerability data.
4. Subjects must have a history of any of the following conditions:
(a) Cirrhosis or decompensated liver function (including ascites, hepatic encephalopathy, or variceal bleeding)
(b) Liver transplant or currently on the liver transplant list
(c) Clinically significant liver disease of any etiology as determined by the trial administrator, including but not limited to alcoholic steatohepatitis, drug-induced, viral or autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemostasis, alpha-1 antitrypsin deficiency (A1AT), and Wilson's disease.
Exceptions include subjects with metabolic dysfunction-related fatty liver disease or metabolic dysfunction-related steatohepatitis. 5. At the screening follow-up visit (first follow-up visit), any of the following results are present:
(a) Alanine aminotransferase/transaminase (ALT) ≥ 3 × upper limit of normal (ULN)
(b) Aspartate aminotransferase/transaminase (AST) ≥ 3 × ULN
(c) Alkaline phosphatase (ALP) ≥ 1.5 × ULN
(d) Total bilirubin (TBIL) ≥ 1.5 × ULN (unless there is a known history of Gilbert's syndrome, a maximum dose of 3 mg/dL [51 µmol/L] may be accepted if direct bilirubin (DBIL) < ULN). 6. Subjects had active hepatitis B/C, defined as:
(a) Positive for hepatitis B core antibody (HBcAb) and positive/detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and/or positive for hepatitis B surface antigen (HBsAg).
(b) Positive for hepatitis C virus (HCV) antibody and positive for HCV ribonucleic acid (RNA).
7. Positive for serum human immunodeficiency virus (HIV) antibody.
8. A history of acute (unless caused by previously remitted cholelithiasis-related pancreatitis and after cholecystectomy) or chronic pancreatitis. Cardiovascular/Renal
9. Cardiac arrhythmias or electrocardiogram (ECG) morphological abnormalities, as determined by the trial administrator, may affect the interpretation of the corrected QTc interval, including ST wave morphology.
(a) Second- or third-degree atrioventricular block or sinoatrial node dysfunction with clinically significant pauses, and not treated with a pacemaker.
(b) Ventricular arrhythmias requiring treatment.
(c) Atrial fibrillation/flutter with a confirmed resting ventricular rate > 100 bpm.
(d) A QT interval corrected for heart rate using Fridericia's formula (QTcF) (the ECG interval measured from the start of the QRS complex to the end of the T wave) > 450 msec, or a family history of congenital long QT syndrome.
10. Within 90 days prior to the screening follow-up visit (1st follow-up visit) and during the screening period, any of the following conditions must have occurred: acute myocardial infarction, unstable angina, transient ischemic attack or stroke, percutaneous coronary intervention, or coronary artery bypass grafting.
11. Severe congestive heart failure (HF) (New York Heart Association Class IV).
12. Subjects diagnosed by the trial administrator with rapidly deteriorating kidney disease (e.g., acute glomerulonephritis) during the screening follow-up visit (1st follow-up visit) or screening period, and who are currently undergoing or planning to undergo dialysis, or who are clinically diagnosed with nephrotic syndrome.
Malignant Tumors
13. History/family history (first-degree relatives) of medullary thyroid carcinoma or type 2 multiple endocrine tumors.
14. History of active malignant tumors within 5 years prior to the screening follow-up visit (1st follow-up visit). Exceptions include appropriately treated basal and squamous cell skin cancer, and carcinoma in situ (e.g., cervical cancer, or carcinoma in situ, or grade 1 [e.g., Gleason 6 or lower] prostate cancer).
Other 15. Any hematological condition that may interfere with HbA1c measurement (e.g., heme disorders, hemolytic anemia, red blood cell transfusion within 90 days prior to the screening follow-up [first follow-up]).
16. A known or suspected history of drug abuse, or a history of alcohol abuse or excessive drinking, which the trial administrator deems likely to affect the subject's safety or adherence to the trial procedures.
Gender and Contraception/Barrier Requirements
17. Women who are lactating, breastfeeding, or pregnant, or women who plan to conceive or begin breastfeeding at any time from the start of screening until 5 days after the last dose of the investigational drug.
Previous/Concomitant Therapies
18. Concomitant use of potent or intermediate-potency cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, or medications with a narrow therapeutic index and sensitivity to CYP3A4, breast cancer resistance protein (BCRP), P-glycoprotein (Pgp), or cytochrome P450 2C8 (CYP2C8).
19. Subjects currently on a lower dose of statin due to prior intolerance to high-intensity doses (e.g., atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg).
20. Received any medication for diabetes treatment not listed in inclusion criterion 3 within 90 days prior to the screening follow-up visit (first follow-up visit) and throughout the screening period.
21. A history of allergy/allergic reaction to GLP-1 RA or excipients as determined by the trial administrator.
22. Received medication related to significant weight gain or glucose abnormalities within 90 days prior to the screening follow-up visit (first follow-up visit) and during the screening period.
Trial-Related
23. The trial administrator believes that the subject's medical history or any existing condition may interfere with the assessment of the trial intervention, expose the subject to risk, affect the subject's ability to participate, or affect the interpretation of trial results.
24. If the trial administrator determines that the subject is unlikely to comply with the trial procedures, restrictions, and requirements, the subject should not participate in the trial.
25. Within 30 days prior to the screening follow-up visit (first follow-up visit) or within 5 drug half-lives (whichever is longer) and during the screening period, the subject received another trial intervention in a clinical trial (excluding GLP-1 RA, which requires a 90-day interval).
26. Participation in any other type of interventional trial concurrently, or prior randomization to this trial.
27 Any AstraZeneca or test center employee directly involved in the planning and/or execution of this trial.
Diabetes
1. Any of the following related medical histories or complications:
(a) Type 1 diabetes mellitus (T1DM), secondary diabetes (including congenital), or ketoacidosis or hyperosmolar coma occurring within 180 days prior to or during the screening follow-up visit (1st follow-up visit).
(b) Currently receiving or expected to receive treatment interventions for diabetic retinopathy and/or macular edema. To confirm participant eligibility, fundus photography or cycloplegic ophthalmoscopy will be performed by an ophthalmologist/optometrist according to the schedule of activities (SoA) or according to local practice.
(c) Having experienced one or more severe hypoglycemic events within 180 days prior to or during the screening follow-up visit (1st follow-up visit), defined as experiencing neurogenic hypoglycemia requiring assistance, or as determined by the trial administrator to have experienced involuntary hypoglycemia or poor recognition of hypoglycemic symptoms.
Weight
2. Any of the following conditions related to medical reasons or planned/previous weight changes:
(a) Received any prescription, over-the-counter, or herbal supplements for weight loss within 90 days prior to the screening follow-up visit (First Follow-up Visit) and up to the screening period.
(b) Received or planned (during the trial period) endoscopic or surgical weight loss procedures (e.g., bariatric surgery or implantation of a weight loss device [e.g., gastric balloon or duodenal barrier]). Exception: Subjects who have had an implanted weight loss device removed and whose weight is stable more than 180 days prior to the screening follow-up visit (First Follow-up Visit) (as described in inclusion criterion 7).
(c) Plans to initiate a targeted weight loss program during the trial period, in addition to lifestyle management as outlined in the trial protocol.
Gastrointestinal/Hepatic Disorders
3. Patients with known clinically significant conditions affecting the upper gastrointestinal (GI) tract (e.g., gastroparesis, gastric outlet obstruction, serious illness, or surgery) or those using any medication that affects gastric motility or gastric emptying (e.g., metoclopramide) that may interfere with the absorption or interpretation of the investigational drug's safety and tolerability data.
4. Subjects must have a history of any of the following conditions:
(a) Cirrhosis or decompensated liver function (including ascites, hepatic encephalopathy, or variceal bleeding)
(b) Liver transplant or currently on the liver transplant list
(c) Clinically significant liver disease of any etiology as determined by the trial administrator, including but not limited to alcoholic steatohepatitis, drug-induced, viral or autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemostasis, alpha-1 antitrypsin deficiency (A1AT), and Wilson's disease.
Exceptions include subjects with metabolic dysfunction-related fatty liver disease or metabolic dysfunction-related steatohepatitis. 5. At the screening follow-up visit (first follow-up visit), any of the following results are present:
(a) Alanine aminotransferase/transaminase (ALT) ≥ 3 × upper limit of normal (ULN)
(b) Aspartate aminotransferase/transaminase (AST) ≥ 3 × ULN
(c) Alkaline phosphatase (ALP) ≥ 1.5 × ULN
(d) Total bilirubin (TBIL) ≥ 1.5 × ULN (unless there is a known history of Gilbert's syndrome, a maximum dose of 3 mg/dL [51 µmol/L] may be accepted if direct bilirubin (DBIL) < ULN). 6. Subjects had active hepatitis B/C, defined as:
(a) Positive for hepatitis B core antibody (HBcAb) and positive/detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and/or positive for hepatitis B surface antigen (HBsAg).
(b) Positive for hepatitis C virus (HCV) antibody and positive for HCV ribonucleic acid (RNA).
7. Positive for serum human immunodeficiency virus (HIV) antibody.
8. A history of acute (unless caused by previously remitted cholelithiasis-related pancreatitis and after cholecystectomy) or chronic pancreatitis. Cardiovascular/Renal
9. Cardiac arrhythmias or electrocardiogram (ECG) morphological abnormalities, as determined by the trial administrator, may affect the interpretation of the corrected QTc interval, including ST wave morphology.
(a) Second- or third-degree atrioventricular block or sinoatrial node dysfunction with clinically significant pauses, and not treated with a pacemaker.
(b) Ventricular arrhythmias requiring treatment.
(c) Atrial fibrillation/flutter with a confirmed resting ventricular rate > 100 bpm.
(d) A QT interval corrected for heart rate using Fridericia's formula (QTcF) (the ECG interval measured from the start of the QRS complex to the end of the T wave) > 450 msec, or a family history of congenital long QT syndrome.
10. Within 90 days prior to the screening follow-up visit (1st follow-up visit) and during the screening period, any of the following conditions must have occurred: acute myocardial infarction, unstable angina, transient ischemic attack or stroke, percutaneous coronary intervention, or coronary artery bypass grafting.
11. Severe congestive heart failure (HF) (New York Heart Association Class IV).
12. Subjects diagnosed by the trial administrator with rapidly deteriorating kidney disease (e.g., acute glomerulonephritis) during the screening follow-up visit (1st follow-up visit) or screening period, and who are currently undergoing or planning to undergo dialysis, or who are clinically diagnosed with nephrotic syndrome.
Malignant Tumors
13. History/family history (first-degree relatives) of medullary thyroid carcinoma or type 2 multiple endocrine tumors.
14. History of active malignant tumors within 5 years prior to the screening follow-up visit (1st follow-up visit). Exceptions include appropriately treated basal and squamous cell skin cancer, and carcinoma in situ (e.g., cervical cancer, or carcinoma in situ, or grade 1 [e.g., Gleason 6 or lower] prostate cancer).
Other 15. Any hematological condition that may interfere with HbA1c measurement (e.g., heme disorders, hemolytic anemia, red blood cell transfusion within 90 days prior to the screening follow-up [first follow-up]).
16. A known or suspected history of drug abuse, or a history of alcohol abuse or excessive drinking, which the trial administrator deems likely to affect the subject's safety or adherence to the trial procedures.
Gender and Contraception/Barrier Requirements
17. Women who are lactating, breastfeeding, or pregnant, or women who plan to conceive or begin breastfeeding at any time from the start of screening until 5 days after the last dose of the investigational drug.
Previous/Concomitant Therapies
18. Concomitant use of potent or intermediate-potency cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, or medications with a narrow therapeutic index and sensitivity to CYP3A4, breast cancer resistance protein (BCRP), P-glycoprotein (Pgp), or cytochrome P450 2C8 (CYP2C8).
19. Subjects currently on a lower dose of statin due to prior intolerance to high-intensity doses (e.g., atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg).
20. Received any medication for diabetes treatment not listed in inclusion criterion 3 within 90 days prior to the screening follow-up visit (first follow-up visit) and throughout the screening period.
21. A history of allergy/allergic reaction to GLP-1 RA or excipients as determined by the trial administrator.
22. Received medication related to significant weight gain or glucose abnormalities within 90 days prior to the screening follow-up visit (first follow-up visit) and during the screening period.
Trial-Related
23. The trial administrator believes that the subject's medical history or any existing condition may interfere with the assessment of the trial intervention, expose the subject to risk, affect the subject's ability to participate, or affect the interpretation of trial results.
24. If the trial administrator determines that the subject is unlikely to comply with the trial procedures, restrictions, and requirements, the subject should not participate in the trial.
25. Within 30 days prior to the screening follow-up visit (first follow-up visit) or within 5 drug half-lives (whichever is longer) and during the screening period, the subject received another trial intervention in a clinical trial (excluding GLP-1 RA, which requires a 90-day interval).
26. Participation in any other type of interventional trial concurrently, or prior randomization to this trial.
27 Any AstraZeneca or test center employee directly involved in the planning and/or execution of this trial.
The Estimated Number of Participants
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Taiwan
144 participants
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Global
900 participants
