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

Phase 3

Recruiting

• Conditions: Hypertension
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT06948422
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Study First Posted: 2025-04-29
• Study Start: 2025-04-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 974

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron (GZL1)	Orforglipron	Participants will receive orforglipron orally or placebo.
Orforglipron (GZL1)	Placebo	Participants will receive orforglipron orally or placebo.
Orforglipron (GZL2)	Orforglipron	Participants will receive orforglipron orally or placebo.
Orforglipron (GZL2)	Placebo	Participants will receive orforglipron orally or placebo.

Primary Outcome Measures

Name	Time	Method
Number of Participants Allocated to Each ISA	Week -8 to Week 0

Trial Locations

Locations (99)

Elite Clinical Studies, LLC; 🇺🇸 Phoenix, Arizona, United States

Valley Clinical Trials, Inc.; 🇺🇸 Northridge, California, United States

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

Excel Medical Clinical Trials; 🇺🇸 Boca Raton, Florida, United States

Care Access - Brandon; 🇺🇸 Brandon, Florida, United States

Northeast Research Institute - Downtown Office; 🇺🇸 Jacksonville, Florida, United States

Peace River Cardiovascular Center; 🇺🇸 Port Charlotte, Florida, United States

Care Access - Sun City Center - Cypress Village Boulevard; 🇺🇸 Sun City Center, Florida, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

Sinai Hospital Of Baltimore; 🇺🇸 Baltimore, Maryland, United States

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