Not recruiting

Study on Semaglutide for Patients with Obesity and Resistant Hypertension to Improve Blood Pressure Control

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called semaglutide on individuals with obesity and resistant hypertension. Obesity is a condition where a person has an excessive amount of body fat, and resistant hypertension is a type of high blood pressure that remains high despite taking multiple medications. The trial aims to see if targeting obesity with semaglutide can help improve blood pressure control compared to a placebo. Semaglutide is administered as a solution for injection using a pre-filled pen, and it is known by the brand names Wegovy and Ozempic.

Participants in the study will receive either semaglutide or a placebo, which is an injection that does not contain any active medication. The study will last for a period of 36 weeks, during which participants will receive regular injections and follow a healthy lifestyle advice program. The trial will monitor changes in blood pressure, body weight, and other health-related factors to assess the effectiveness and safety of semaglutide in managing resistant hypertension and obesity.

The study will also evaluate the acceptability of the treatment by observing any side effects and the number of participants who continue with the treatment. Additionally, the trial will gather information on participants' quality of life, health beliefs, and medication adherence. The goal is to determine if semaglutide can be a beneficial treatment option for people with obesity and resistant hypertension, potentially leading to better blood pressure control and overall health improvements.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes verifying a body mass index (BMI) of 30 or higher and resistant hypertension, which is high blood pressure that remains uncontrolled despite taking three or more medications, including a diuretic.
Step 2
Randomization
Participants are randomly assigned to receive either the medication semaglutide or a placebo. This process ensures that the study results are unbiased.
Step 3
Medication administration
The medication semaglutide is administered as a solution for injection under the skin (subcutaneous). The dosage varies: 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, or 2.4 mg, depending on the specific product used. The placebo is an injection with an empty syringe, designed to mimic the administration process.
Step 4
Treatment period
The treatment period lasts for 36 weeks. During this time, participants continue their usual lifestyle and medication regimen, with the addition of the trial medication or placebo.
Step 5
Monitoring and follow-up
Regular monitoring of blood pressure and other health indicators is conducted to assess the effects of the treatment. Participants report any side effects or changes in health status.
Step 6
Final assessment
At the end of the 36-week period, a final assessment is conducted to evaluate changes in blood pressure, weight, and overall health. The results contribute to understanding the effectiveness and safety of semaglutide in managing resistant hypertension and obesity.

Who can join the trial?

6 criteria

The patient must have **obesity**, which means having a **Body Mass Index (BMI)** of 30 or higher. **BMI** is a number calculated from a person's weight and height.
check
The patient must have **resistant hypertension**, which means:
- The average **systolic blood pressure** (the top number in a blood pressure reading) is 130 mmHg or higher, measured at least six times at home.
- The patient is taking three or more medications to lower blood pressure, including a **diuretic**. A **diuretic** is a type of medicine that helps the body get rid of extra salt and water.
- The patient must provide **written informed consent** to participate, which means they agree to join the study and are available for study activities.
- The study is open to both **male** and **female** participants.
- The study includes participants from a **vulnerable population**, which means people who might need extra protection or care.

Who cannot join the trial?

4 criteria

Individuals with certain cardiovascular disorders, such as hypertension (high blood pressure) and obesity (having too much body fat), may not be eligible.
Participants must be within specific age ranges, which are not specified here.
Both male and female participants are considered for the study.
People who are part of a vulnerable population may not be eligible. This term refers to groups who might need special protection or care, such as children, elderly, or those with certain disabilities.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
University Hospital Galway
Galway, Ireland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Semaglutide is a medication used in this trial to help people with obesity and resistant high blood pressure. It works by helping to control appetite and reduce body weight, which may also help in managing blood pressure levels. The trial aims to see if using semaglutide can improve blood pressure control in these patients.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered as a subcutaneous injection, typically once a week. It is currently being studied in clinical trials for its potential benefits in treating obesity and resistant hypertension. The main therapeutic indications include managing obesity and improving blood pressure control in individuals with resistant hypertension. At the molecular level, semaglutide works by mimicking a hormone called GLP-1, which helps regulate appetite and insulin secretion. It is classified as a GLP-1 receptor agonist, a type of medication that influences blood sugar levels and appetite control.

Investigated diseases

Hypertension
Hypertension, also known as high blood pressure, is a condition where the force of the blood against the artery walls is consistently too high. Over time, this increased pressure can cause damage to the blood vessels and organs, such as the heart, kidneys, and brain. It often develops over many years and may not show symptoms initially, making it a silent condition. As it progresses, it can lead to complications like heart disease, stroke, and kidney problems. Regular monitoring and lifestyle changes are crucial in managing this condition.
Obesity
Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the body mass index (BMI), with a BMI of 30 or higher indicating obesity. This condition develops gradually over time due to factors like poor diet, lack of physical activity, and genetic predisposition. Obesity can lead to various health issues, including type 2 diabetes, heart disease, and certain cancers. It often requires long-term lifestyle changes to manage effectively.