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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06948422

Enrollment

974

Registered

2025-04-29

Start date

2025-04-30

Completion date

2027-09-01

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGOrforglipron

Administered orally.

DRUGPlacebo

Administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of Participants Allocated to Each ISA	Week -8 to Week 0

Countries

Argentina, China, Czechia, Germany, Greece, India, Japan, Poland, Puerto Rico, Spain, United States

Contacts

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026