臨床研究等提出・公開システム

Japanese

Date of registration	June. 26, 2026
Last modified on	June. 26, 2026
Trial ID	jRCT2031260261

Scientific Title	The purpose of this study is 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 (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication. (Eluminate-5)
Public Title	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)

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. 16, 2026
Target sample size		165
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 (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	- 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
Intervention(s)		Experimental: Elecoglipron dose level 1 + dapagliflozin Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily. Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin Dapagliflozin administered orally once daily. Experimental: Elecoglipron dose level 2 + dapagliflozin Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily. Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin Dapagliflozin administered orally once daily. Experimental: Elecoglipron dose level 1 + dapagliflozin-matched placebo Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily. Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin-matched placebo A placebo matching dapagliflozin administered orally once daily. Experimental: Elecoglipron dose level 2 + dapagliflozin-matched placebo Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily. Drug: Elecoglipron Elecoglipron is administered orally once daily. Drug: Dapagliflozin-matched placebo A placebo matching dapagliflozin administered orally once daily. Active Comparator: Elecoglipron-matched placebo + dapagliflozin Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily. Drug: Dapagliflozin Dapagliflozin administered orally once daily. Drug: Elecoglipron-matched placebo A placebo matching elecoglipron 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)	NCT07662109
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Argentina/Brazil/China/the Czech Republic/Denmark/Germany/Greece/Hungary/India/Malaysia/Mexico/Poland/Slovaki/South Africa/South Korea/Taiwan/Thailand/Turkey/Ukraine/United Kingdom/United States of America/Vietnam