Clinical trial

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

Active, not recruiting · Phase 3 · 5 countries · Registry ID NCT06948422

Active, not recruitingPhase 3Interventional

What this study is about

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionHypertension

Full registry 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

Treatments and study arms

Orforglipron

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

Number of Participants Allocated to Each ISAWeek -8 to Week 0

Study locations

100 locations were listed when this page was built. The first 40 are shown.

CEMEDIC🇦🇷 Buenos Aires, Argentina