Study on Semaglutide for Weight Loss in Patients with HIV and Obesity

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people living with HIV and obesity. The treatment being tested is a medication called Ozempic, which contains the active substance semaglutide. Semaglutide is a type of medication known as a GLP-1 analogue, which is used to help with weight loss. The study will compare the effects of semaglutide, in addition to diet and exercise, against diet and exercise alone.

The purpose of the study is to see if semaglutide can help people with HIV and obesity lose more weight than they would with just diet and exercise. Participants in the study will receive semaglutide as an injection using a pre-filled pen. The study will last for several weeks, during which participants will be monitored for changes in their body weight and other health markers. Some participants will receive a placebo instead of semaglutide to help researchers understand the true effects of the medication.

Throughout the study, researchers will also look at other health factors, such as changes in body fat, immune system function, and overall quality of life. The study aims to provide valuable information on how semaglutide can be used to support weight loss in people living with HIV and obesity, potentially leading to better health outcomes for this group.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, HIV status, and body mass index (BMI).

Written informed consent is required to participate in the trial.

2 initial assessment

An initial assessment is conducted to establish baseline measurements, including total body weight and other health markers.

This assessment helps in tracking changes throughout the study.

3 treatment phase

The treatment involves the administration of semaglutide, a medication given as an injection.

The dosage starts with Ozempic 0.25 mg solution for injection in a pre-filled pen.

The dosage is gradually increased to Ozempic 0.5 mg and then to Ozempic 1 mg as per the study protocol.

Injections are administered once a week.

4 diet and exercise

Participants are advised to follow a specific diet and exercise regimen.

This is to assess the efficacy of semaglutide as an adjunct to these lifestyle changes.

5 mid-study evaluation

At week 16, an evaluation is conducted to measure weight loss and other health markers.

The proportion of participants not achieving at least 5% weight loss from baseline is assessed.

6 final assessment

At week 28, a final assessment is conducted to measure changes in total body weight and other health markers.

Secondary outcomes such as changes in fat distribution, immune function, and quality of life are also evaluated.

7 end of study

The study is estimated to conclude by October 31, 2026.

Participants are informed of the study results and any relevant findings related to their health.

Who Can Join the Study?

Be over 18 years old
Have a positive test for HIV-1 antibodies, which are proteins the body makes in response to the HIV virus, using a specific type of test called a 3rd or 4th generation Ag/Ab ELISA assay
Be on stable ART (antiretroviral therapy) for at least 2 years, with the last two viral loads (amount of HIV in the blood) being less than 40 copies/mL, according to local testing rules
Have a CD4 count of 200 cells/mm³ or more for at least 1 year. CD4 cells are a type of white blood cell that helps the body fight infections
Have a BMI (Body Mass Index) of 30 kg/m² or more, or have a BMI of 27 kg/m² or more along with hypertension (high blood pressure), dyslipidaemia (abnormal amount of fats in the blood), or type 2 diabetes mellitus (a condition where the body has trouble using insulin properly)
Understand the study procedures, be able to follow them, and voluntarily agree to participate by giving written informed consent for the trial

Who Cannot Join the Study?

Individuals who do not have both HIV and obesity cannot participate. HIV is a virus that affects the immune system, and obesity means having too much body fat.
Participants must be within the specified age range, which is not detailed here.
Both males and females are eligible, but specific criteria may exclude some individuals.
People who are considered part of a vulnerable population may be excluded. A vulnerable population includes groups who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Universita’ Degli Studi Di Modena E Reggio Emilia	Modena	Italy
University Hospital Galway	Galway	Ireland
Rigshospitalet	Copenhagen	Denmark
Sb Vaodfxaticyvvrs Uxznavgipt Hukaquwv	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2022
Ireland	Recruiting	01.06.2022
Italy	Not yet recruiting	01.06.2022

Trial locations

Investigated drugs:

Semaglutide

Semaglutide is a medication used in this trial to help with weight loss. It is a GLP-1 analogue, which means it mimics a hormone in the body that helps regulate appetite and food intake. In this study, semaglutide is given as an injection under the skin. The goal is to see if adding semaglutide to a diet and exercise plan can help people living with HIV and obesity lose more weight compared to just following the diet and exercise plan alone.

Investigated diseases:

Human Immunodeficiency Virus (HIV) Infection – HIV is a virus that attacks the body’s immune system, specifically the CD4 cells (T cells), which help the immune system fight off infections. Over time, HIV can destroy so many of these cells that the body can’t fight off infections and disease. The progression of HIV can lead to acquired immunodeficiency syndrome (AIDS), the most severe phase of HIV infection. During this phase, the immune system is badly damaged, and the body becomes vulnerable to opportunistic infections and certain cancers. Without treatment, HIV can gradually weaken the immune system, but with proper medical care, it can be controlled.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that presents a risk to health. It is commonly measured using the body mass index (BMI), where a BMI of 30 or higher is considered obese. Obesity can develop gradually over time due to a combination of genetic, behavioral, and environmental factors. It often leads to various health issues, including heart disease, diabetes, and joint problems. The condition can affect individuals of all ages and is influenced by lifestyle factors such as diet and physical activity. Managing obesity typically involves lifestyle changes, including diet and exercise.

Trial ID:

2024-513168-24-00

Protocol code:

Semaglutide_2019

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Semaglutide for Weight Loss in Patients with HIV and Obesity

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