NCT06482853 Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
| NCT ID | NCT06482853 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2025-01-23 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Amy Arnold, PhD
PRINCIPAL INVESTIGATOR
Pennsylvania State University College of Medicine
Frequently Asked Questions
Who can join the NCT06482853 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06482853 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06482853 currently recruiting?
Yes, NCT06482853 is actively recruiting participants. Contact the research team at acauffman@pennstatehealth.psu.edu for enrollment information.
Where is the NCT06482853 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT06482853 clinical trial?
NCT06482853 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Amy Arnold, PhD at Pennsylvania State University College of Medicine. The trial plans to enroll 52 participants.
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