ObesityEarly Phase 1NCT06482853
Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
A Early Phase 1 study testing Angiotensin-(1-7) and Saline in people with Obesity and Hypertension, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Angiotensin-(1-7) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to Mar 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Amy Arnold, PhD, 717-531-3674, aarnold5@pennstatehealth.psu.edu
Urs A Leuenberger, MD
About this study
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.
Read the detailed description
A randomized, double blind, placebo controlled, crossover study will be conducted to determine if acute intravenous angiotensin-(1-7) infusion reduces cardiovascular sympathetic tone and blood pressure and improves the function of blood vessels in participants with obesity hypertension. This is an outpatient study that requires a screening visit, and if eligible, two study visits separated by at least one week in the Clinical Research Center within the Penn State Milton S. Hershey Medical Center. The study visits will include intravenous infusion of angiotensin-(1-7) or saline for approximately two hours, starting with increasing doses and holding at a steady-state dose. Endothelial function will be measured and blood samples collected at baseline and at the end of infusion. Blood pressure, heart rate, and muscle sympathetic nerve activity (via microneurography) will be measured continuously throughout the study. Each study visit will last approximately 4 hours.
- Conditions
- Obesity, Hypertension
- Being tested
- Angiotensin-(1-7), Saline
- Keywords
- Angiotensin-(1-7), Cardiovascular, Sympathetic Nervous System, Blood Pressure, Endothelial Function
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin-(1-7)Drug
Also called Angiotensin I/II (1-7) Acetate
This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.
SalineDrug
Also called Normal saline, 0.9% sodium chloride
Saline will be used as the placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin-(1-7) | Experimental | 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. Receives: Drug: Angiotensin-(1-7) |
| Saline | Placebo comparator | 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Sympathetic Nerve Burst Rate
Muscle sympathetic nerve burst rate will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Brachial Artery Diameter
A blood pressure cuff will be inflated to a suprasystolic pressure for 5 minutes then deflated. Brachial artery diameter will be measured continuously before, during, and after cuff inflation using duplex ultrasound at baseline and at the end of angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Secondary outcomes (7)
Change in Muscle Sympathetic Nerve Burst Incidence
Muscle sympathetic nerve burst incidence will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Muscle Sympathetic Nerve Amplitude
Muscle sympathetic nerve amplitude will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Muscle Sympathetic Nerve Total Activity
Muscle sympathetic nerve total activity will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Systolic Blood Pressure
Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Diastolic Blood Pressure
Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Heart Rate
Heart rate will be measured continuously by electrocardiogram during angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Change in Plasma Catecholamines
Circulating catecholamine levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start23 Jan 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Amy Arnold, Milton S. Hershey Medical Center
- Investigators
- Amy Arnold, PhD, Principal investigator, Pennsylvania State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482853
- Sponsor's protocol ID
- STUDY 8170-Part 2
- Other IDs
- R01HL170140
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
- ClinicalTrials.gov ID
- NCT06482853
- Acronym / sponsor ID
- STUDY 8170-Part 2
- Conditions
- Obesity, Hypertension
- Keywords
- Angiotensin-(1-7), Cardiovascular, Sympathetic Nervous System, Blood Pressure, Endothelial Function
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, double blind, placebo controlled, crossover study will be conducted to determine if acute intravenous angiotensin-(1-7) infusion reduces cardiovascular sympathetic tone and blood pressure and improves the function of blood vessels in participants with obesity hypertension. This is an outpatient study that requires a screening visit, and if eligible, two study visits separated by at least one week in the Clinical Research Center within the Penn State Milton S. Hershey Medical Center. The study visits will include intravenous infusion of angiotensin-(1-7) or saline for approximately two hours, starting with increasing doses and holding at a steady-state dose. Endothelial function will be measured and blood samples collected at baseline and at the end of infusion. Blood pressure, heart rate, and muscle sympathetic nerve activity (via microneurography) will be measured continuously throughout the study. Each study visit will last approximately 4 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiotensin-(1-7) | Experimental | Drug: 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. |
| Saline | Placebo comparator | Drug: SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin-(1-7)Also: Angiotensin I/II (1-7) AcetateThis is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure. | Drug | Angiotensin-(1-7) |
| SalineAlso: Normal saline, 0.9% sodium chlorideSaline will be used as the placebo comparator. | Drug | Saline |
Primary outcome
Change in Muscle Sympathetic Nerve Burst Rate
Time frame: 120 minutes
Muscle sympathetic nerve burst rate will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
Change in Brachial Artery Diameter
Time frame: 120 minutes
A blood pressure cuff will be inflated to a suprasystolic pressure for 5 minutes then deflated. Brachial artery diameter will be measured continuously before, during, and after cuff inflation using duplex ultrasound at baseline and at the end of angiotensin-(1-7) versus saline infusion.
7 secondary outcomes
Change in Muscle Sympathetic Nerve Burst Incidence
Time frame: 120 minutes
Change in Muscle Sympathetic Nerve Amplitude
Time frame: 120 minutes
Change in Muscle Sympathetic Nerve Total Activity
Time frame: 120 minutes
Change in Systolic Blood Pressure
Time frame: 120 minutes
Change in Diastolic Blood Pressure
Time frame: 120 minutes
Change in Heart Rate
Time frame: 120 minutes
Change in Plasma Catecholamines
Time frame: 120 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Arnold, PhD principal investigator
Pennsylvania State University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Angiotensin-(1-7) and Saline in people with Obesity and Hypertension, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimee Cauffman, RN (717-531-1617, acauffman@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Sympathetic Nerve Burst Rate (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.