Clinical Trials List
Protocol NumberD7261C00002
NCT Number(ClinicalTrials.gov Identfier)NCT07662044
Not yet recruiting
2026-06-01 - 2028-12-31
Phase III
Not yet recruiting1
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- 張建偉 Division of Cardiovascular Diseases
- 黃天祈 Division of Cardiovascular Diseases
- Mei Yueh Lee Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
Principal Investigator
Yi-Ching Yang
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Type 2 Diabetes Mellitus
Objectives
此為一項全球性、隨機分配、雙盲、平行分組、多中心、第 3 期試驗，旨在評估 elecoglipron 單一療法或合併 dapagliflozin 相較於安慰劑，僅透過生活型態管理或穩定劑量 metformin 治療效果不佳之第 2 型糖尿病 (T2DM) 成人受試者的療效、安全性和耐受性。
Test Drug
錠劑
膜衣錠
膜衣錠
Active Ingredient
Elecoglipron
Dapagliflozin
Dapagliflozin
Dosage Form
110
116
116
Dosage
5 mg, 15 mg, 20 mg, 45 mg
10 mg
10 mg
Endpoints
評估 elecoglipron 45 mg、elecoglipron 65 mg 和 elecoglipron 65 mg + dapagliflozin 10 mg 相較於安慰劑在下列方面的療效：血糖控制
Inclution Criteria
Inclusion Criteria:
Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to screening
Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening
T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to screening
Exclusion Criteria
Exclusion Criteria:
Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
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 has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
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
Severe congestive heart failure (New York Heart Association IV)
History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
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 has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
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
Severe congestive heart failure (New York Heart Association IV)
History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
The Estimated Number of Participants
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Taiwan
50 participants
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Global
800 participants
