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Semaglutide for reducing visceral fat in adults with HIV, BMI 25–30 kg/m2 and no diabetes: randomized trial with lifestyle intervention

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on adults living with HIV infection who are on stable antiretroviral therapy and have a body weight index ( BMI ) between 25 and 30 kg/m² without diabetes. These individuals often carry excess fat around the organs, known as visceral adipose tissue. The medication being tested is semaglutide, an injection that may help reduce this deep‑body fat when added to a structured diet and exercise plan.

The purpose of the study is to find out whether adding semaglutide to the lifestyle program leads to a greater loss of visceral fat after 12 months compared with the lifestyle program alone. Participants will be randomly assigned to receive either the medication or no medication while all follow the same diet and activity guidelines. Throughout the year, they will undergo body scans using DEXA, which measures bone and fat composition, and a scan called Positron Emission Tomography that can show inflammation in blood vessels.

At the start, participants will have baseline measurements taken, then receive weekly injections if assigned to the medication group, and attend regular clinic visits for safety checks and counseling on diet and exercise. After about a year, the same measurements will be repeated to assess changes in body fat and overall health.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    You will meet with study staff to confirm that you meet the eligibility criteria, including having HIV infection, a body‑mass index between 25 and 30 kg/m², and no diabetes.

    You will sign a consent form that explains the trial, the procedures, and your rights as a participant.

  2. Step 2

    Baseline Measurements

    A whole‑body DEXA scan will be performed to measure your visceral adipose tissue (VAT) and overall body composition.

    A PET scan using the tracer FDG will assess vascular inflammation.

    Blood samples will be taken to evaluate metabolic and immune markers, and you will complete questionnaires about your health and daily activities.

    Physical performance tests will be conducted to establish a baseline for strength and mobility.

  3. Step 3

    Start of Structured Lifestyle Intervention and First Injection

    You will receive counseling on diet, physical activity, and other lifestyle changes designed to support weight loss.

    The first dose of semaglutide will be administered by injection. The initial dose is 0.25 mg, given once a week.

  4. Step 4

    Medication Titration and Ongoing Injections

    Weekly injections of semaglutide will continue for the duration of the trial, which is 12 months.

    The dose may be increased at scheduled intervals, following the study protocol, using the available strengths of 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg, each also given once a week.

    Dose adjustments are made to improve tolerability and effectiveness while monitoring safety.

  5. Step 5

    Regular Follow‑Up Visits

    You will attend clinic visits approximately every month. During each visit, study staff will check your weight, body‑mass index, and any side effects.

    Blood will be drawn to monitor glucose, liver function, and inflammatory markers.

    You will receive the next weekly injection of semaglutide and reinforcement of the lifestyle recommendations.

  6. Step 6

    Mid‑Study Assessments

    At about 6 months, another DEXA scan will be performed to evaluate changes in visceral fat.

    A repeat PET scan may be done to assess any changes in vascular inflammation.

    Additional questionnaires will be completed to capture changes in quality of life and physical performance.

  7. Step 7

    Final Assessment at Month 12

    At the end of the 12‑month period, a final DEXA scan will measure the percentage change in visceral adipose tissue.

    A final PET scan will evaluate vascular inflammation.

    Blood tests, physical performance tests, and patient‑reported outcome questionnaires will be repeated.

    Your final dose of semaglutide will be administered, and the study medication will be discontinued.

  8. Step 8

    Study Completion

    After the final visit, your participation concludes. The collected data will be analyzed to determine the effect of semaglutide combined with the lifestyle program on visceral fat and related health outcomes.

Who can join the trial?

10 criteria

  • Age: You must be older than 18 years.
  • HIV infection and stable antiretroviral therapy (ART): You must have HIV and have been taking the same HIV medicines without change for at least 12 weeks.
  • Undetectable HIV RNA: The amount of HIV in your blood must be so low it cannot be measured (less than 50 copies per milliliter).
  • Body mass index (BMI): Your BMI must be 25 or higher but less than 30 kg/m². BMI is a number that compares your weight to your height.
  • DEXA‑derived VAT area of at least 140 cm²: A special scan (DEXA) that measures body fat must show that the fat around your internal organs (visceral adipose tissue) is 140 cm² or more.
  • Waist circumference or waist‑to‑hip ratio: Your waist must be at least 94 cm if you are a man or at least 80 cm if you are a woman, or your waist‑to‑hip ratio must be at least 1.00 for men or 0.85 for women. These measurements help assess belly fat.
  • Informed consent: You must be able to read, understand, and sign a consent form that explains the study and your rights.
  • Willingness to follow study procedures: You must agree to attend all visits, follow the study instructions, and be available for the entire study period.
  • No other weight‑loss programme or bariatric/metabolic surgery: You must not plan to join any other weight‑loss program or have weight‑loss surgery while the study is running.
  • Women of childbearing potential: If you could become pregnant, you need a negative pregnancy test at screening and at the start of the study, and you must agree to use a highly effective contraceptive method throughout the study and for at least two months after the last dose of the study drug.

Who cannot join the trial?

17 criteria

  • Known diabetes mellitus (a condition where blood sugar is too high)
  • Previous use of semaglutide or other GLP-1 receptor agonists (medicines that affect blood sugar control)
  • Previous major cardiovascular event, such as a myocardial infarction (heart attack), stroke, or procedures to open blocked heart or blood vessels (coronary or peripheral revascularization)
  • Active malignancy (cancer) that is currently being treated, except skin cancer that has been completely removed (non‑melanoma skin cancer)
  • Severe hepatic (liver) or renal (kidney) impairment, as judged by the doctor
  • Personal or family history of medullary thyroid cancer (a rare type of thyroid gland cancer)
  • Pregnancy or breastfeeding
  • Any reason that makes a PET scan or taking semaglutide unsafe (contraindication)
  • Any active or chronic uncontrolled inflammatory condition, infection, or cancer
  • Any significant illness within 14 days before joining the study that is not already listed as an exclusion
  • Physical or mental disability, or a lab test abnormality, that could increase risk or affect study results
  • Regular use of medicines that affect the immune system (immunomodulators), except constant use of NSAIDs (common pain relievers) for at least 6 months without plans to change
  • Use of megestrol acetate, testosterone, or any steroid beyond normal body amounts within 6 months, or intention to start them
  • Elevated serum lipase level more than 1.5 times the normal upper limit at screening (an enzyme that can signal pancreas problems)
  • History of excessive alcohol use (average two or more drinks each day)
  • History of pancreatitis (inflammation of the pancreas)
  • Allergy (hypersensitivity) to the study drug or any of its ingredients
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Investigated drugs

Wegovy is an injectable medication that contains the active ingredient semaglutide. It works by mimicking a natural hormone that helps control appetite and blood sugar. In the study, participants receive Wegovy by using a pre‑filled pen that they inject under the skin. The medication is being tested to see if it can reduce the amount of fat stored around the organs (visceral fat) when added to other health measures.

The structured lifestyle intervention is a program that includes guidance on healthy eating, regular physical activity, and behavioral counseling. Participants meet with health professionals who help them set realistic goals, track their progress, and make lasting changes to their daily habits. This therapy is used as the standard care in the trial, and the researchers want to know if adding Wegovy to this program leads to greater reductions in visceral fat.

What is already known about the treatment

Semaglutide - Semaglutide is given as a solution for injection using a pre‑filled pen that the patient pushes under the skin. It is an approved drug used to help people lose weight and to control blood sugar in type 2 diabetes, and it is widely described in medical studies. The medicine works by copying a natural hormone called GLP‑1, which tells the pancreas to release insulin, slows down stomach emptying and reduces appetite, leading to lower calorie intake. It belongs to the class of GLP‑1 receptor agonists, a type of peptide hormone therapy.

Investigated diseases

HIV infection - HIV infection is a viral disease that targets the immune system, especially the CD4 + T‑cells that help fight infections. After an initial acute phase with flu‑like symptoms, the virus establishes a chronic presence in the body. Over time, the number of CD4 + cells gradually declines, reducing the body's ability to respond to other pathogens. This decline can lead to increased susceptibility to opportunistic infections and other health problems. The disease course varies, but without effective control the immune damage progresses steadily.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526738-18-00Protocol codeSHAPEEstimated enrolment66 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

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