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NCT Number: NCT06948422

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEMEDIC, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally.

Other names: LY3502970

Placebo

Drug

Administered orally.

Primary outcomes

  1. Number of Participants Allocated to Each ISA

    Time frame: Week -8 to Week 0

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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