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Evaluating orforglipron for treating hypertension in overweight or obese individuals

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)

Phase 3 Interventional Eli Lilly and Company · NCT06948422

This study tests if a new medication called orforglipron can help people who are overweight or obese lower their high blood pressure.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment974 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations100 sites (Phoenix, Arizona and 99 other locations)
Trial IDNCT06948422 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of orforglipron, a novel treatment, for managing hypertension in participants who are overweight or obese. It utilizes a master protocol to support two independent studies, focusing on individuals with elevated blood pressure levels. Participants will be monitored for their blood pressure responses and overall health while receiving either the medication or a placebo. The study seeks to establish a comprehensive framework for evaluating this treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults with hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) and a body mass index (BMI) of 25 kg/m² or higher.

Not a fit: Patients with severely elevated blood pressure (≥ 170/110 mmHg), secondary causes of hypertension, or certain cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for managing hypertension in patients with obesity or overweight, potentially improving their overall health outcomes.

How similar studies have performed: Other studies have shown promise in treating hypertension with novel medications, but this specific approach with orforglipron is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 99 other locations

+50 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hypertension
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.