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Clinical Trials List

Protocol NumberD7261C00003
NCT Number(ClinicalTrials.gov Identfier)NCT07662109
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 and Dapagliflozin in Combination, Compared With Elecoglipron Alone and Dapagliflozin Alone, in Adults With Type 2 Diabetes Mellitus (Eluminate-5)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator Hao-Chang Hung Division of Endocrinology
Chi Mei Medical Center

Co-Principal Investigator

Principal Investigator 裴馰 Division of Endocrinology
Fu Jen Catholic University Hospital

Co-Principal Investigator

Principal Investigator 曾士婷 Division of Endocrinology
Kuang Tien General Hospital

Co-Principal Investigator

Principal Investigator 朱志勳 Division of Endocrinology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

Principal Investigator 杜思德 Division of Endocrinology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

Principal Investigator 江珠影 Division of Endocrinology
Far Eastern Memorial Hospital

Co-Principal Investigator

Principal Investigator JUN-SING WANG Division of Endocrinology
Taichung Veterans General Hospital

Co-Principal Investigator

Principal Investigator 劉鳳炫 Division of Endocrinology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

Principal Investigator CHIH-YUAN WANG Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

Principal Investigator 黃建寧 Division of Endocrinology
Chung Shan Medical University Hospital

Co-Principal Investigator

Principal Investigator Yi-Ching Yang
National Taiwan University Hospital

Co-Principal Investigator

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 dapagliflozin 單一療法，僅透過生活型態管理或穩定劑量 metformin 治療效果不佳之 T2DM 成人受試者的療效、安全性和耐受性。

Test Drug

錠劑
膜衣錠

Active Ingredient

Elecoglipron
Dapagliflozin

Dosage Form

110
116

Dosage

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

Endpoints

評估 elecoglipron 65 mg + dapagliflozin 10 mg 相較於 dapagliflozin 10 mg 單一療法在下列方面的療效：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

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

The Estimated Number of Participants

  • Taiwan

    144 participants

  • Global

    2000 participants

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