Tesamorelin for HIV-Related Lipodystrophy

Overseen By Pamela Freda, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Columbia University

Must be taking: Antiretrovirals

Must not be taking: Glucocorticoids

Disqualifiers: Diabetes, Malignancy, Renal, Liver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the drug tesamorelin affects body fat and metabolism in people with HIV lipodystrophy, a condition where fat is unevenly distributed in the body. Participants will receive daily tesamorelin injections for a year while researchers monitor changes in body composition and metabolic health. Individuals living with HIV-related fat accumulation, who are on stable HIV therapy and have consistent weight, might be a good fit for this study. As a Phase 4 trial, tesamorelin is already FDA-approved and proven effective; this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must have been on a stable anti-retroviral therapy for at least 8 weeks before joining. It's best to discuss your specific medications with the trial team.

What is the safety track record for tesamorelin?

In previous studies, tesamorelin has shown some safety data for people with HIV-related lipodystrophy. Research indicates that allergic reactions occurred in about 3.6% of patients using tesamorelin, meaning allergic reactions were uncommon. The FDA has already approved tesamorelin for reducing excess belly fat in people with HIV-related lipodystrophy, suggesting the treatment is generally safe for this use. However, individual reactions vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for HIV-related lipodystrophy focus on lifestyle changes and medications like metformin or growth hormone therapy. But Tesamorelin works differently, targeting and reducing visceral fat through its role as a Growth Hormone-Releasing Hormone (GHRH) analogue. Researchers are excited because Tesamorelin is administered via a simple daily subcutaneous injection, potentially offering a more direct and effective approach to managing this condition. Additionally, its targeted mechanism could provide a more tailored treatment option, possibly leading to better outcomes for patients.

What evidence suggests that tesamorelin might be an effective treatment for HIV-related lipodystrophy?

Studies have shown that tesamorelin effectively treats HIV-related lipodystrophy, a condition characterized by fat accumulation in certain body areas. Research indicates that tesamorelin reduces fat stored around internal organs. Specifically, results from previous patients demonstrated that it not only reduces this type of fat but also improves overall body image for those with HIV-related lipodystrophy. The positive effects last for up to a year with ongoing treatment. This treatment is already approved and has proven effective in managing this condition. Participants in this trial will receive a daily subcutaneous injection of 2 mg of tesamorelin, with regular visits to monitor safety and effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Pamela U. Freda, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for HIV-infected adults with lipodystrophy and central fat buildup, having a waist circumference over set limits. They must have stable weight, controlled HIV viral load, normal fasting glucose levels, be on consistent anti-retroviral therapy for at least 8 weeks, and have a CD4 count above 100 cells/mm3. It excludes those with diabetes needing medication, abnormal kidney/liver function, pregnant women or those not using contraception, cancer history or certain hormonal disorders.

Inclusion Criteria

Weight stable for 8 weeks prior to enrollment

HIV RNA load <1000 copies/mL

Abdominal fat accumulation defined as: Waist Circumference (WC) 102 cm for men, 88 cm for women, except in subjects of East/South Asian ethnicity in whom this will be defined by WC 90 cm for men and 80 cm for women

Exclusion Criteria

I am not pregnant or using reliable birth control if of childbearing age.

Known hypersensitivity to tesamorelin and/or mannitol

I have had cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily subcutaneous injections of tesamorelin 2 mg for 12 months

12 months

6 visits (in-person) at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tesamorelin

Trial Overview The study tests the effects of tesamorelin (a growth hormone-releasing hormone analog) on body composition in patients with HIV lipodystrophy. Participants will receive daily subcutaneous injections of tesamorelin for up to 12 months and undergo body composition testing, tissue biopsies, metabolic rate measurements and insulin sensitivity assessments before treatment as well as after 6 and 12 months.

How Is the Trial Designed?

Group I: Tesamorelin Experimental Treatment 1 Intervention

Subjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit.

Tesamorelin is already approved in United States for the following indications:

Approved in United States as Egrifta for:

• Lipodystrophy

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Tesamorelin, a growth hormone-releasing factor analog, has shown efficacy in reducing excess visceral fat in HIV-infected patients, based on results from two phase III clinical trials.

Further long-term studies are needed to assess the safety of tesamorelin and its potential to lower cardiovascular risks linked to HIV-associated lipodystrophy and improve body fat distribution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth hormone-releasing factor agonists for the treatment of HIV-associated lipodystrophy. Hu, M., Tomlinson, B.[2017]

Tesamorelin is effective in reducing visceral adipose tissue (VAT) in patients with HIV-associated lipodystrophy, as shown in two 26-week clinical trials, with benefits maintained for up to 52 weeks in those who continued treatment.

The treatment is generally well tolerated, with serious side effects occurring in less than 4% of patients, primarily involving injection-site reactions and common growth hormone-related issues, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on tesamorelin in HIV-associated lipodystrophy. Dhillon, S.[2017]

Tesamorelin has been shown to significantly reduce waist circumference and visceral adipose tissue in patients with HIV-associated lipodystrophy after 26 weeks of treatment, improving body image as well.

The treatment was found to maintain these improvements without negatively affecting blood glucose and lipid levels, indicating its safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. Spooner, LM., Olin, JL.[2022]

Tesamorelin, a growth hormone-releasing factor analogue, was approved by the FDA in November 2010 specifically for reducing excess abdominal fat in HIV-infected patients with lipodystrophy.

This approval highlights tesamorelin's efficacy in addressing a significant health issue related to body fat distribution in individuals with HIV, providing a targeted treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tesamorelin. Grunfeld, C., Dritselis, A., Kirkpatrick, P.[2021]

In a post hoc analysis of a phase III clinical trial involving participants treated with tesamorelin for 26 weeks, the drug effectively reduced visceral adipose tissue (VAT) and waist circumference in individuals with and without dorsocervical fat.

The results indicate that tesamorelin is equally effective in reducing excess VAT regardless of the presence of dorsocervical fat, suggesting it can be a suitable treatment option for all patients with HIV-related fat accumulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tesamorelin in people with HIV with and without dorsocervical fat: Post hoc analysis of phase III double-blind placebo-controlled trial. Rahman, F., McLaughlin, T., Mesquita, P., et al.[2023]

Tesamorelin is effective in reducing visceral adipose tissue (VAT) in patients with HIV-associated lipodystrophy, as demonstrated in two 26-week clinical trials, with benefits maintained for up to 52 weeks in those who continued treatment.

The treatment is generally well tolerated, with serious side effects occurring in less than 4% of patients, primarily involving injection-site reactions and common growth hormone-related issues, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy. Dhillon, S.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT00608023

TH9507 Extension Study in Patients With HIV-Associated ... HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20554713/

Effects of tesamorelin (TH9507), a growth hormone ... Conclusions: Treatment with tesamorelin reduces VAT and maintains the reduction for up to 52 wk, preserves abdominal sc adipose tissue, improves body image and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947601/

Effect of tesamorelin in people with HIV with and without ... Tesamorelin is equally effective and should be considered in the treatment of excess VAT regardless of the presence of dorsocervical fat.

4. natap.org natap.org/2008/DrugResistance/DrugRes_03.htm

Effect of Tesamorelin (TH9507), a Growth Hormone ... Results: Mean age was 48±7 (SD) years, waist circumference 105±9 cm, BMI 29±4 kg/m2, CD4 cell count 599±290 cells/mm3, and 76% of patients had undetectable HIV ...

5. medscape.com medscape.com/viewarticle/758381

Tesamorelin for HIV-associated Lipodystrophy Conclusions: Tesamorelin is effective in improving visceral adiposity and body image in patients with HIV-associated lipodystrophy over 26–52 weeks of treatment ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf

EGRIFTA® (tesamorelin for injection), for subcutaneous use Hypersensitivity reactions occurred in 3.6% of patients with HIV-associated lipodystrophy treated with EGRIFTA® in the Phase 3 clinical trials.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539131/

Clinical Review Report: Tesamorelin (Egrifta) - NCBI Bookshelf The objective of this systematic review was to evaluate the beneficial and harmful effects of tesamorelin for the treatment of excess VAT, as assessed by waist ...

8. empr.com empr.com/news/egrifta-wr-now-available-for-hiv-related-lipodystrophy/

Egrifta WR Now Available for HIV-Related Lipodystrophy Egrifta WR™, a new concentrated formulation (F8) of tesamorelin, is now available for the reduction of excess abdominal fat in HIV-infected ...

9. molinahealthcare.com molinahealthcare.com/providers/wa/medicaid/resource/PDF/egrifta-tesamorelin-mcp131.pdf

Egrifta Tesamorelin Molina Clinical Policy 131 ⌘ While Egrifta™ (tesamorelin) is FDA-approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, an improvement in net ...

10. natap.org natap.org/2010/HIV/BriefingFDA.pdf

FDA Briefing Materials EGRIFTA (tesamorelin acetate for ... 800,000 HIV-infected patients may exhibit the clinical manifestation of HIV lipodystrophy and represent a potential target for therapeutic interventions aimed ...