臨床研究等提出・公開システム

Japanese

Date of registration	June. 12, 2025
Last modified on	July. 18, 2025
Trial ID	jRCT2031250164

Scientific Title	A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION) (J2A-MC-GZPL )
Public Title	A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening) (J2A-MC-GZPL)

Contact for Scientific Queries	Name	Masaki Takeshi
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com
Contact for Public Queries	Name	Trial Guide Call Center
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 27, 2025
Actual date of first enrollment		June. 26, 2025
Target sample size		974
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	screening
Key inclusion & exclusion criteria	Inclusion Criteria	- Has systolic blood pressure (SBP) >= 140 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg (if DBP criteria alone is met, SBP must be >=130 mmHg) at screening (Visit 1). - Has SBP >= 140 mmHg and/or DBP >= 90 mmHg (if DBP criteria alone is met, SBP must be >=130 mmHg) at week 0 (Visit 3). - Untreated for hypertension, or on stable antihypertensive medications >= 30 days prior to Visit 1. - Have a body mass index (BMI) >= 25 kg/m2.
	Exclusion Criteria	- Has SBP >=170 mmHg and/or DBP >=110 mmHg at Visit 1 or at Visit 3. - Has known secondary causes of hypertension - Have heart failure with reduced ejection fraction (HFrEF) diagnosis - Have had any of the following conditions within 90 days prior to screening. * hospitalization for hypertension or for congestive heart failure * acute coronary syndrome or acute myocardial infarction, or * cerebrovascular accident (stroke). - Have type 1 diabetes (T1D) - Have acute or chronic hepatitis, including a history of autoimmune hepatitis
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hypertension
Intervention(s)		DRUG: Orforglipron(Other Name: LY3502970) Administered orally. DRUG: Placebo Administered orally. (Study Arms) Experimental: Orforglipron (GZL1) Participants will receive orforglipron orally or placebo. Interventions: Drug: Orforglipron Drug: Placebo Experimental: Orforglipron (GZL2) Participants will receive orforglipron orally or placebo. Interventions: Drug: Orforglipron Drug: Placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Number of Participants Allocated to Each ISA [ Time Frame: Week -8 to Week 0
Secondary Outcome(s)

Primary Sponsor	Eli Lilly Japan K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-6665-0572
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Mar. 28, 2025

Plan to share IPD	Yes
Plan description	Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Secondary ID(s)	NCT06948422, NCT06948435, NCT06952530
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Argentina/China/Czechia/Germany/Greece/India/Poland/Puerto Rico/Spain

History of Changes

No	Publication date
2	July. 18, 2025	(this page)	Changes
1	June. 12, 2025	Detail

List of change history