ClinicalTrials.gg
RecruitingNCT06482853Updated Sep 24, 2026

Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension

An Early Phase 1 interventional study of Angiotensin-(1-7) and Saline in Obesity and Hypertension, sponsored by Milton S. Hershey Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Milton S. Hershey Medical Center · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Obesity by Milton S. Hershey Medical Center — 2 open to participants now, 2 under way, none of them phase 3. Obesity · Milton S. Hershey Medical Center.

Planned enrollment
10th of 14
52 · median 91
Started
2025
the only one that year
Phase 1
2 of 17
1 open now
Registered
16th of 17
by date

Among the 17 studies in Obesity by Milton S. Hershey Medical Center, this one is the 10th largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2025, is one of 2 in phase 1, and was the 16th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

2 of the 17 studies in Obesity by Milton S. Hershey Medical Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Obesity by Milton S. Hershey Medical Center, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Obesity
  • Hypertension

Keywords

  • Angiotensin-(1-7)
  • Cardiovascular
  • Sympathetic Nervous System
  • Blood Pressure
  • Endothelial Function
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women of all races
  • Age 18 to 65 years
  • (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
  • Fluent in written and spoken English
  • Satisfactory history and physical exam

Exclusion criteria

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
  • > 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, )
  • History or presence of immunological or hematological disorders
  • Impaired hepatic function [ (AST) or alanine transaminase (ALT) levels >2 times ]
  • 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 therapy (>7 consecutive days in 1 month)
  • Treatment with any drug in the 1-month preceding the study
  • Inability to give, or withdraw,
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (estimated)

Study 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.

    Drug: Angiotensin-(1-7)

  • 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.

    Drug: Saline

Interventions

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

    Also known as: Angiotensin I/II (1-7) Acetate

  • DrugSaline

    Saline will be used as the placebo comparator.

    Also known as: Normal saline, 0.9% sodium chloride

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 120 minutes

  2. 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.

    Time frame: 120 minutes

Secondary outcomes

  1. 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.

    Time frame: 120 minutes

  2. 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.

    Time frame: 120 minutes

  3. 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.

    Time frame: 120 minutes

  4. Change in Systolic Blood Pressure

    Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  5. Change in Diastolic Blood Pressure

    Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  6. Change in Heart Rate

    Heart rate will be measured continuously by electrocardiogram during angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  7. 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.

    Time frame: 120 minutes

Other outcomes

  1. Change in Angiotensin II

    Plasma angiotensin II levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  2. Change in Angiotensin-(1-7)

    Plasma angiotensin-(1-7) levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  3. Change in Renin Activity

    Plasma renin activity will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  4. Change in Aldosterone

    Plasma or serum aldosterone levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  5. Change in Heart Rate Variability

    Heart rate variability will be calculated from the continuous electrocardiogram recordings obtained during angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

  6. Change in Baroreflex Sensitivity

    Baroreflex sensitivity will be calculated from the continuous blood pressure and electrocardiogram recordings obtained during angiotensin-(1-7) versus saline infusion.

    Time frame: 120 minutes

07

Study locations

1 of 1 sites recruiting
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
    Recruiting
    • Amy Arnold, PhD · Contactaarnold5@pennstatehealth.psu.edu · 717-531-3674
    • Urs A Leuenberger, MD · Sub investigator
    • Aimee Cauffman, RN · Sub investigator
    • Cheryl Blaha, RN · Sub investigator
    • Jian Cui, PhD · Sub investigator
    • Takuto Hamaoka, MD, PhD · Sub investigator
    • Mami Hamaoka, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be available to other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Mar 2029, 50 months after the start.

Of 105 non-industry phase 1 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 50 months is above that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2024
First posted
Jul 1, 2024
StartActual
Jan 23, 2025
Primary completionEst.
Mar 2029
CompletionEst.
Mar 2029
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06482853
Responsible party
Amy Arnold (Associate Professor, Milton S. Hershey Medical Center) — Principal investigator
First posted
Jul 1, 2024
Start date
Jan 23, 2025
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Sep 24, 2026

Study contacts

Aimee Cauffman, RN
Contact
acauffman@pennstatehealth.psu.edu
717-531-1617
Amy Arnold, PhD
Contact
aarnold5@pennstatehealth.psu.edu
717-531-3674
Amy Arnold, PhD
principal investigator · Pennsylvania State University College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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