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

NCT06948422
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
974
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Lead sponsor
Eli Lilly and Company
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Start date
2025-04-30
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Number of sites
100
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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.
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Short title
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
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Official 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)
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-09-01
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First posted
2025-04-29
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Registry last updated
2026-05-29
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Primary completion date
2027-09-01
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Start date
2025-04-30
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Participants
974
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Participant count basis
Estimated
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Planned participants
974
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Protocol amendments
0
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Number of sites
100
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06948422
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ClinicalTrials.gov ID
NCT06948422
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Screening
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. Number of Participants Allocated to Each ISA

    Timeframe: Week -8 to Week 0

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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

Sources for eligibility
clinicaltrials.gov

  • Elite Clinical Studies, LLCPhoenix, United States
  • Valley Clinical Trials, Inc.Covina, United States
  • Valley Clinical Trials, Inc.Northridge, United States
  • Chase Medical Research, LLCWaterbury, United States
  • Excel Medical Clinical TrialsBoca Raton, United States
  • Care Access - BrandonBrandon, United States
  • Northeast Research Institute - Downtown OfficeJacksonville, United States
  • Care Access - St. PetersburgSt. Petersburg, United States
  • East-West Medical Research InstituteHonolulu, United States
  • Sinai Hospital Of BaltimoreBaltimore, United States
  • Ascension Saint Agnes Heart CareBaltimore, United States
  • Lucida Clinical TrialsNew Bedford, United States
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United States
  • StudyMetrix ResearchCity of Saint Peters, United States
  • Excel Clinical Research, LLCLas Vegas, United States
  • Palm Research Center SunsetLas Vegas, United States
  • Rochester Clinical Research, LLCRochester, United States
  • Remington-Davis, IncColumbus, United States
  • PriMED Clinical ResearchDayton, United States
  • Advanced Research Institute - TigardTigard, United States
  • Care Access - MauldinMauldin, United States
  • Dallas Heart and Vascular Consultants, PADuncanville, United States
  • Texas Institute of Cardiology, PAMcKinney, United States
  • North Hills Family Medicine/North Hills Medical ResearchNorth Richland Hills, United States
  • Advanced Research InstituteOgden, United States

And 75 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2A-MC-GZPL
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)