What side effects are associated with this type of intervention?

Common treatments for lipohypertrophy, particularly GLP-1 receptor agonists like Semaglutide, include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Other potential side effects are decreased appetite, weight loss, and in some cases, pancreatitis. Additionally, there may be an increased risk of thyroid C-cell tumors, as observed in rodent studies, though this has not been confirmed in humans. It is important for patients to discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for various conditions, including type 2 diabetes and obesity, which are relevant to the treatment of lipohypertrophy. Notably, semaglutide has been approved for type 2 diabetes and weight management. Other GLP-1 receptor agonists, such as liraglutide, have also been approved for similar indications, including type 2 diabetes and obesity. These drugs work by enhancing insulin secretion, reducing appetite, and promoting weight loss, which can be beneficial in managing conditions like lipohypertrophy.

What other types of research exist?

Promising alternatives to Semaglutide for lipohypertrophy patients include: 1) Tesamorelin, a growth hormone-releasing factor analogue, which has shown efficacy in reducing visceral fat. 2) Metformin, particularly for patients with coexisting type 2 diabetes mellitus, as it can reduce visceral and abdominal fat. 3) Poly-L-lactic acid (injectable filler) for cosmetic correction of facial lipoatrophy. These options should be discussed with a healthcare provider to tailor treatment to individual patient needs.

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GLP-1 Receptor Agonist

Semaglutide for HIV-Associated Lipohypertrophy

Q: What is the mechanism of action of this treatment?

GLP-1 receptor agonists, such as semaglutide, work by mimicking the incretin hormone GLP-1, which enhances glucose-dependent insulin secretion, inhibits glucagon release, and slows gastric emptying. These actions collectively improve insulin sensitivity and reduce visceral fat accumulation, which is crucial for patients with lipohypertrophy. By targeting visceral fat, these treatments help mitigate the metabolic complications associated with lipohypertrophy, such as insulin resistance and increased cardiovascular risk.

Phase 2

Waitlist Available

Led By Grace A McComsey, MD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.

Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men, and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV treatment.

Must not have

Any active or chronic uncontrolled inflammatory condition, infection or cancer

Glomerular filtration rate <50 cc/min/1.73 m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial tests semaglutide, a medication that controls blood sugar, in people with HIV who have abnormal fat accumulation. It aims to see if the drug can reduce fat, improve blood vessel function, and lower inflammation. Semaglutide has been used to improve blood sugar levels and reduce body weight in individuals with obesity and type 2 diabetes.

Who is the study for?

Adults over 18 with HIV and obesity (BMI ≥25 kg/m²) who have experienced increased abdominal size after starting HIV treatment. Participants must be on stable antiretroviral therapy, with controlled HIV-1 RNA levels for at least 6 months, and not planning to change their HIV medication or start a weight loss program during the study. Women of childbearing potential must test negative for pregnancy and agree to use contraception.

What is being tested?

The trial is testing Semaglutide, a drug that may reduce fat accumulation and improve heart health in people with HIV-associated lipohypertrophy. It's compared against a placebo in a randomized, double-blinded setup to see if it changes visceral fat, insulin resistance, inflammation markers, and cardiovascular risk.

What are the potential side effects?

Semaglutide can cause digestive issues like nausea or diarrhea, increase the risk of low blood sugar levels especially when combined with other diabetes medications, possible thyroid tumors including cancer (rare), pancreatitis (inflammation of the pancreas), gallbladder problems like gallstones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a consistent HIV treatment for the last year.

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My waist size and ratio are high due to HIV treatment.

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I have confirmed HIV-1 infection.

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I have been on a consistent HIV medication regimen for the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any ongoing infections, inflammations, or untreated cancers.

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My kidney function is reduced.

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I have had moderate to severe stomach issues in the past month.

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I am not pregnant or breastfeeding.

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I have a history of heavy drinking, pancreatitis, thyroid cancer, or MEN syndrome type 2.

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I have used growth hormone treatments in the past year or plan to start.

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I am not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of semaglutide on quantity of abdominal fat (total, subcutaneous, visceral)

Effects of semaglutide on quantity of fat (total body fat, limb fat, trunk fat)

Effects of semaglutide on quantity of pericardial fat

Secondary study objectives

Effects of semaglutide on EndoPat

Effects of semaglutide on anthropometric measurements (weight, waist circumference, waist-to-hip ratio)

Effects of semaglutide on bone

+45 more

Other study objectives

Changes over time in HIV-associated lipohypertrophy

Effects of semaglutide on adipokines and natriuretic peptides

Effects of semaglutide on neurocognitive scores

+6 more

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants with HIV and lipohypertrophy: semaglutide armExperimental Treatment1 Intervention

Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.

Group II: Participants with HIV and lipohypertrophy: placebo armPlacebo Group1 Intervention

Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

FDA approved

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as semaglutide, work by mimicking the incretin hormone GLP-1, which enhances glucose-dependent insulin secretion, inhibits glucagon release, and slows gastric emptying. These actions collectively improve insulin sensitivity and reduce visceral fat accumulation, which is crucial for patients with lipohypertrophy. By targeting visceral fat, these treatments help mitigate the metabolic complications associated with lipohypertrophy, such as insulin resistance and increased cardiovascular risk.

Wegovy (semaglutide): a new weight loss drug for chronic weight management.