臨床研究等提出・公開システム

Japanese

Date of registration	June. 29, 2026
Last modified on	June. 29, 2026
Trial ID	jRCT2031260268

Scientific Title	The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function. (Eluminate-4)
Public Title	A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)

Contact for Scientific Queries	Name	Tsugumi Hirotaka
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	RD-clinical-information-Japan@astrazeneca.com
Contact for Public Queries	Name	Tsugumi Hirotaka
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	RD-clinical-information-Japan@astrazeneca.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 06, 2026
Target sample size		118
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening - TL2i or SGLT2i-naive and other glucose lowering medication(s) - HbA1c value: 1. On stable dose of SGLT2i >_ 7.0% to <_ 10.5% (53 to 91.3 mmol/mol) 2. SGLT2i-naive >_ 7.5% to <_ 10.5% (58 to 91.3 mmol/mol) - Impaired renal function - 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	- 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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 Diabetes Mellitus and Impaired Renal Function
Intervention(s)		Experimental: Elecoglipron dose level 1 Participants will receive elecoglipron at dose level 1, administered orally once daily, in addition to background dapagliflozin 10 mg. Drug: Elecoglipron Elecoglipron is administered orally once daily. Experimental: Elecoglipron dose level 2 Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg. Drug: Elecoglipron Elecoglipron is administered orally once daily. Placebo Comparator: Placebo Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg. Drug: Placebo Placebo is administered orally once daily.
Primary Outcome(s)		Change from baseline in Hemoglobin A1c (HbA1c)[Time frame: Baseline to Week 40]

Primary Sponsor	Astrazeneca K.K

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Polaris Institutional Review Board
Address	4-4-16-301, Hon-cho, Kawaguchi-shi, Saitama-ken , Saitama
Telephone	+81-42-648-5551
Approval Status	Approval
Date of approval	May. 22, 2026

Plan to share IPD	Yes
Plan description	Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Plan to share IPD

Yes

Plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Secondary ID(s)	NCT07662135
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Bulgaria/China/Denmark/Germany/India/Malaysia/ Mexico/Spain/Taiwan/Thailand/Turkey/Ukraine/United Kingdom/United States of America/Vietnam