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Semaglutide for HIV-Associated Lipohypertrophy
Study Summary
This trial will assess the effect of semaglutide on visceral and ectopic fat in people with HIV, as well as changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I do not have any ongoing infections, inflammations, or untreated cancers.My kidney function is reduced.My belly has gotten bigger since starting HIV treatment.I have had moderate to severe stomach issues in the past month.I have been on a consistent HIV treatment for the last year.You are willing to comply with all study procedures and are available for the duration of the study.I am not pregnant or breastfeeding.I am 18 years old or older.I am a woman who cannot get pregnant or my male partner cannot father a child.I have signed and understand the consent form.I use certain medications regularly without changes, including NSAIDs or statins, and my thyroid condition is under control.I have confirmed HIV-1 infection.I am not trying to conceive and will use multiple forms of birth control if sexually active.I have been on a consistent HIV medication regimen for the last year.My waist size and ratio are high due to HIV treatment.You have a higher than normal body weight for your height.I haven't used steroids or hormone therapies like megestrol or testosterone in the last 6 months.I have a history of heavy drinking, pancreatitis, thyroid cancer, or MEN syndrome type 2.I am 18 years old or older.I have used growth hormone treatments in the past year or plan to start.I won't change my HIV treatment, start a weight loss or exercise program, or have surgery during the study.I have heart disease or diabetes, or I've been taking metformin steadily for 6 months without a diabetes diagnosis.I am not pregnant.
- Group 1: Participants with HIV and lipohypertrophy: placebo arm
- Group 2: Participants with HIV and lipohypertrophy: semaglutide arm
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What medicinal purpose is Semaglutide Injectable Product typically utilized for?
"Semaglutide Injectable Product is a viable solution for enduring weight management, reduced-calorie diets, and exercise regimens."
How many participants are engaging in this experiment?
"Yes, the data on clinicaltrials.gov affirms that this research study is still seeking participants. This investigation was originally listed in May of 2019 and most recently edited on July 25th 2022. In total, 104 patients are being sought after from two sites."
Are there any previous studies that have featured Semaglutide Injectable Product?
"Semaglutide Injectable Product was first examined in 2018 at a Novo Nordisk Investigational Site. To date, 18434 clinical trials have concluded, with 58 active studies primarily based out of Cleveland, Ohio."
Has the FDA given their stamp of approval to Semaglutide Injectable Product?
"Our team has evaluated the safety of Semaglutide Injectable Product and deemed it worthy of a score of 2, which is indicative that data exists suggesting its safety but efficacy still needs to be established."
Is this investigation a pioneering effort?
"Since its initiation in 2018, sponsored by Novo Nordisk A/S, a Phase 4 drug approval trial for Semaglutide Injectable Product has been taking place across 55 countries and 772 cities. To date, 58 live studies are still active with 18434 trials having already concluded successfully."
Are there presently opportunities for participation in this experiment?
"According to the clinicaltrials.gov website, this medical trial is still open for enrolment. It was first listed on May 16th 2019 and last revised on July 25th 2022."
What is the purpose of this experimental research?
"The 56-week trial aims to assess the impact of semaglutide on visceral abdominal fat. Secondary objectives include measuring changes in liver fat, gut hormones (GIP and GLP-1 levels) via mixed meal test tolerance, and pulse wave velocity as a surrogate measure for cardiovascular disease risk."
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