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

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Hypertension

Treatments: Drug: Orforglipron; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06948422

27223

J2A-MC-GZPL (Other Identifier)

J2A-MC-GZL1 (Other Identifier)

J2A-MC-GZL2 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 974 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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974 participants in 2 patient groups

Orforglipron (GZL1)

Experimental group

Description:

Participants will receive orforglipron orally or placebo.

Treatment:

Drug: Placebo

Drug: Orforglipron

Orforglipron (GZL2)

Experimental group

Description:

Participants will receive orforglipron orally or placebo.

Treatment:

Drug: Placebo

Drug: Orforglipron