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

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What is this study about?

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.

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.

2 randomization

Participants are randomly assigned to receive either the medication semaglutide or a placebo. This process ensures that the study results are unbiased.

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.

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.

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.

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 Study?

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.
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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centric Health Navan Road	Dublin	Ireland
University Hospital Galway	Galway	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	09.12.2024

Trial locations

Investigated drugs:

Semaglutide

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.

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.

Trial ID:

2024-513958-29-00

Protocol code:

TRI CRF 23-05

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?