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) studied | Hypertension |
| Date of first enrollment | 26/06/2025 |
| Target sample size | 974 |
| Countries of recruitment | United States,Japan,Argentina,Japan,China,Japan,Czechia,Japan,Germany,Japan,Greece,Japan,India,Japan,Poland,Japan,Puerto Rico,Japan,Spain,Japan |
| Study type | Interventional |
| 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 Outcome | Number of Participants Allocated to Each ISA [ Time Frame: Week -8 to Week 0 |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| 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
| Primary Sponsor | Masaki Takeshi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | NCT06948422, NCT06948435, NCT06952530 |
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 |
| 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 |
| LTG_CallCenter@lists.lilly.com | |
| Affiliation | Eli Lilly Japan K.K. |