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JAPANESE
JRCT ID: jRCT2031250164

Registered date:12/06/2025

A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment26/06/2025
Target sample size974
Countries of recruitmentUnited States,Japan,Argentina,Japan,China,Japan,Czechia,Japan,Germany,Japan,Greece,Japan,India,Japan,Poland,Japan,Puerto Rico,Japan,Spain,Japan
Study typeInterventional
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

Outcome(s)

Primary OutcomeNumber of Participants Allocated to Each ISA [ Time Frame: Week -8 to Week 0
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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.
Exclude 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

Related Information

Contact

Public contact
Name Trial Guide Call Center
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.
Scientific contact
Name Takeshi Masaki
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.