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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.

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 data supports the effectiveness of the drug Tesamorelin for reducing excess abdominal fat in patients with HIV-related lipodystrophy?

Research shows that Tesamorelin is effective in reducing visceral adipose tissue (deep belly fat) in people with HIV-related lipodystrophy, with improvements in body composition and waist size. These benefits were maintained for those who continued the treatment for up to 52 weeks, although stopping the drug led to the return of the fat. ^{1 2 3 4 5}

Is tesamorelin safe for humans?

Tesamorelin has been generally well tolerated in clinical trials for HIV-associated lipodystrophy, with some serious side effects occurring but not commonly. Long-term safety data is still needed to fully understand its effects. ^{1 2 3 4 6}

How is the drug Tesamorelin unique in treating HIV-related lipodystrophy?

Tesamorelin is unique because it is the first and only drug specifically approved to reduce excess abdominal fat in patients with HIV-associated lipodystrophy by stimulating the body's own growth hormone production. Unlike other treatments, it effectively reduces visceral fat without significantly affecting subcutaneous fat, and improvements in body composition and image are maintained with continued use. ^{1 2 3 4 6}

Research Team

Pamela U. Freda, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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, 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tesamorelin. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. New Zealand pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. [2022]

5. England 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Growth hormone-releasing factor agonists for the treatment of HIV-associated lipodystrophy. [2017]