Recruiting
Early Phase 1

Angiotensin-(1-7)

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06482853

Conditions

Obesity

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Angiotensin-(1-7)

Saline

Study Details

Brief summary:

Obesity is a global health concern that is associated with high blood pressure and an increased risk for developing cardiovascular disease. The purpose of this study is to find out if the investigational drug angiotensin-(1-7) can improve cardiovascular health in people with obesity and high blood pressure.

Conditions

Obesity

Hypertension

Study ID

NCT06482853

Start date

Jan 23, 2025

Status verified date

Sep, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women of all races
  • Age 18 to 65 years
  • Body mass index (BMI) between 30-45 kg/m2
  • Pre-hypertension (defined as two or more seated blood pressure readings >120/80 mmHg) or hypertension (defined as two or more seated blood pressure readings >130/80 mmHg or use of antihypertensive medications)
  • Capable of giving informed consent
  • Fluent in written and spoken English
  • Satisfactory history and physical exam

Exclusion Criteria:

  • Age ≤ 17 or ≥ 66 years
  • Taking more than two antihypertensive medications
  • Secondary causes of hypertension (e.g., pheochromocytoma, primary aldosteronism, aortic coarctation, adrenal disease)
  • Pregnant or nursing women
  • Women taking hormone replacement therapy within 6 months
  • Decisional impairment
  • Prisoners
  • Alcohol or drug abuse
  • Current smokers
  • Highly trained athletes
  • Subjects with >5% weight change in the past 3 months
  • BMI > 45 kg/m2
  • Evidence of type I or type II diabetes (fasting glucose > 126 mg/dL or use of anti-diabetic medications)
  • History of serious cardiovascular disease (e.g. myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke, transient Ischemic attack)
  • History or presence of immunological or hematological disorders
  • Impaired hepatic function \[aspartate aminotransferase (AST) or alanine transaminase (ALT) levels >2 times upper limit of normal range\]
  • Impaired renal function (serum creatinine >2.0 mg/dl)
  • Anemia
  • Treatment with drugs increasing sympathetic activity \[e.g., serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors, stimulants\]
  • Treatment with phosphodiesterase-5 inhibitors
  • Treatment with anticoagulants (e.g. warfarin)
  • Treatment with chronic systemic glucocorticoid therapy (>7 consecutive days in 1 month)
  • Treatment with any investigational drug in the 1-month preceding the study
  • Inability to give, or withdraw, informed consent

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Angiotensin-(1-7)

Participants will receive intravenous angiotensin-(1-7) at one study visit for a total of 120 minutes. Angiotensin-(1-7) will be given in escalating doses of 2 ng/kg/min, 4 ng/kg/min, and 8 ng/kg/min. Each of these doses will be infused for 10 minutes. Following this 30 minute dose escalation period, angiotensin-(1-7) will be given at 8 ng/kg/min for an additional 90 minutes. Infusion rates will be calculated for each patient based on body mass.

placebo comparator: Saline

Participants receive intravenous saline at one study visit for a total of 120 minutes. The volume of saline will match the volume of angiotensin-(1-7) infused. Infusion rates will be calculated for each patient based on body mass.

Interventions

Angiotensin-(1-7)

This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.

Saline

Saline will be used as the placebo comparator.

Primary outcome measure

  • Change in Muscle Sympathetic Nerve Burst Rate [ Time Frame: 120 minutes ]
  • Change in Brachial Artery Diameter [ Time Frame: 120 minutes ]

Central Contacts and Locations

Central contacts

Aimee Cauffman, RN

717-531-1617acauffman@pennstatehealth.psu.edu

Amy Arnold, PhD

717-531-3674aarnold5@pennstatehealth.psu.edu

Locations

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Amy Arnold, PhD

717-531-3674aarnold5@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • Angiotensin-(1-7)
  • Cardiovascular
  • Sympathetic Nervous System
  • Blood Pressure
  • Endothelial Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-09-19.