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

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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 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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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Investigated drugs

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.

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 effectiveness in aiding weight loss in individuals living with HIV and obesity. The medication is primarily used for managing type 2 diabetes and obesity. It works by mimicking a hormone called GLP-1, which helps regulate appetite and food intake by acting on receptors in the brain. Semaglutide belongs to the pharmacological class of GLP-1 receptor agonists.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513168-24-00Protocol codeSemaglutide_2019Estimated enrolment80 patientsSponsorUniversity College Dublin

sourced from the EU Clinical Trials Register and site verification

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