tesamorelin
updated
What is tesamorelin?
Tesamorelin is a GHRH analog that binds pituitary GHRH receptors and increases pulsatile endogenous growth-hormone release. Growth hormone then drives IGF-1 production and other downstream effects. The clinical trials show a net change in fat compartments; they do not isolate IGF-1 as the sole causal signal.
Tesamorelin reduces excess abdominal fat in adults with HIV and lipodystrophy. It stimulates growth-hormone release and raises IGF-1. In withdrawal studies, visceral fat returned after treatment stopped.
Growth hormone-releasing hormone analog
- Prescription peptide medicine
- Acts through endogenous GH release
- Egrifta WR and Egrifta SV are not interchangeable
What problem is tesamorelin approved to treat?
The current Egrifta WR label covers reduction of excess abdominal fat in adults with HIV and lipodystrophy. The label explicitly says it is not indicated for weight-loss management and that long-term cardiovascular safety has not been established.
Egrifta WR label · HIV lipodystrophy
FDA prescribing information
Theratechnologies. Egrifta WR prescribing information, 2025.
Defines the adult HIV-lipodystrophy indication, states that tesamorelin is not a weight-loss medicine, separates WR from SV handling, and lists malignancy, pregnancy, pituitary-axis, IGF-1, fluid, glucose, hypersensitivity, and injection warnings.
- Participants / model
- Adults with HIV and lipodystrophy who have excess abdominal fat
- Treatment
- Prescription tesamorelin injection sold as Egrifta WR
- Study design
- Regulatory prescribing information
Long-term cardiovascular safety has not been established, and the label is not a general-obesity approval.
Read the original sourceWhat did the pivotal HIV trial show?
A 26-week randomized trial included 412 adults with HIV and treatment-associated abdominal-fat accumulation. Visceral adipose tissue changed -15.2% with tesamorelin and +5.0% with placebo. The sample was 86% men, and the primary endpoint was CT-measured visceral fat.
- Tesamorelin
- -15.2%
- Placebo
- 5%
The trial also reported lipid changes, but it did not establish a reduction in heart attacks, strokes, or mortality.
Falutz trial · HIV visceral fat
Randomized, placebo-controlled trial
Falutz J et al. New England Journal of Medicine, 2007.
In 412 adults with HIV and abdominal-fat accumulation, CT-measured visceral fat changed -15.2% with tesamorelin and +5.0% with placebo at 26 weeks.
- Participants / model
- Adults with HIV and treatment-associated central fat accumulation; 86% men
- Treatment
- Daily subcutaneous tesamorelin 2 mg or placebo
- Follow-up
- 26 weeks
- Study design
- Randomized, placebo-controlled trial
- Funding
- Theratechnologies
The primary endpoint was visceral-fat imaging, not body weight or a cardiovascular event.
Read the original sourceDoes less visceral fat mean visible belly fat or scale weight must fall?
Visceral fat sits around abdominal organs and is measured by imaging. It differs from subcutaneous fat under the skin and from total body weight. In the 60-person non-HIV study, visceral-fat area fell versus placebo while the subcutaneous-fat difference was not significant.
| Endpoint | What it answers | What it does not prove |
|---|---|---|
| Visceral-fat area | Fat around abdominal organs on CT or MRI | Visible subcutaneous fat loss |
| Subcutaneous-fat area | Fat under the skin in the measured region | General weight loss |
| Body weight or BMI | Whole-body size | Which fat compartment changed |
Non-HIV trial · selected obesity population
Randomized, double-blind trial
Makimura H et al. Journal of Clinical Endocrinology and Metabolism, 2012.
In 60 adults with abdominal obesity and reduced GH secretion, tesamorelin reduced visceral-fat area versus placebo over 12 months, without a significant subcutaneous-fat change.
- Participants / model
- Adults with abdominal obesity and reduced GH secretion, without the HIV-lipodystrophy selection used for the approval
- Treatment
- Daily tesamorelin 2 mg or placebo
- Follow-up
- 12 months
- Study design
- Randomized, double-blind, placebo-controlled trial
- Funding
- NIH research support
Small selected-population study; it does not establish a broad obesity indication or long-term clinical outcome benefit.
Read the original sourceEgrifta WR label · HIV lipodystrophy
FDA prescribing information
Theratechnologies. Egrifta WR prescribing information, 2025.
Defines the adult HIV-lipodystrophy indication, states that tesamorelin is not a weight-loss medicine, separates WR from SV handling, and lists malignancy, pregnancy, pituitary-axis, IGF-1, fluid, glucose, hypersensitivity, and injection warnings.
- Participants / model
- Adults with HIV and lipodystrophy who have excess abdominal fat
- Treatment
- Prescription tesamorelin injection sold as Egrifta WR
- Study design
- Regulatory prescribing information
Long-term cardiovascular safety has not been established, and the label is not a general-obesity approval.
Read the original sourceHas tesamorelin been tested outside HIV lipodystrophy?
A 12-month randomized trial in 60 abdominally obese adults with reduced GH secretion found a placebo-corrected reduction in visceral-fat area. Use for general obesity remains experimental.
The study selected people with both abdominal obesity and reduced GH secretion. It was small, and its imaging endpoint does not establish routine obesity treatment or long-term clinical benefit.
Non-HIV trial · selected obesity population
Randomized, double-blind trial
Makimura H et al. Journal of Clinical Endocrinology and Metabolism, 2012.
In 60 adults with abdominal obesity and reduced GH secretion, tesamorelin reduced visceral-fat area versus placebo over 12 months, without a significant subcutaneous-fat change.
- Participants / model
- Adults with abdominal obesity and reduced GH secretion, without the HIV-lipodystrophy selection used for the approval
- Treatment
- Daily tesamorelin 2 mg or placebo
- Follow-up
- 12 months
- Study design
- Randomized, double-blind, placebo-controlled trial
- Funding
- NIH research support
Small selected-population study; it does not establish a broad obesity indication or long-term clinical outcome benefit.
Read the original sourceDoes the visceral-fat reduction persist after treatment stops?
A randomized extension found that visceral fat remained reduced during continued treatment but reaccumulated after participants switched to placebo. The reduction was maintained through 52 weeks in participants who continued treatment.
Extension trial · visceral-fat reaccumulation
Randomized withdrawal extension
Falutz J et al. AIDS, 2008.
Visceral-fat reduction was sustained through 52 weeks with continued tesamorelin, while visceral fat reaccumulated after switching from tesamorelin to placebo.
- Participants / model
- Adults with HIV and central fat accumulation who entered the extension after the initial randomized phase
- Treatment
- Continue tesamorelin or switch to placebo after 26 weeks
- Follow-up
- 52 weeks total
- Study design
- Randomized treatment-extension and withdrawal study
- Funding
- Theratechnologies
Participants entered the extension after completing the initial 26-week trial.
Read the original sourceDid tesamorelin reduce liver fat in people with HIV?
A preliminary six-month trial randomized 50 antiretroviral-treated adults with HIV and abdominal fat accumulation; 48 received study drug. Liver fat changed by a median -2.0 percentage points with tesamorelin and +0.9 with placebo, a net difference of -2.9 points. Visceral-fat area also fell more with tesamorelin.
This small imaging trial did not establish prevention of cirrhosis, liver failure, cardiovascular events, or death. The authors explicitly called the study preliminary and said the clinical importance and long-term consequences remained uncertain.
JAMA trial · preliminary liver-fat result
Randomized, double-blind, placebo-controlled trial
Stanley TL et al. JAMA, 2014.
Fifty antiretroviral-treated adults with HIV and abdominal fat accumulation were randomized and 48 received study drug. At six months, the net treatment difference was -42 cm2 for visceral-fat area and -2.9 percentage points for liver-fat fraction.
- Participants / model
- Men and women with HIV, abdominal fat accumulation, and antiretroviral treatment
- Treatment
- Daily tesamorelin 2 mg or placebo
- Follow-up
- Six months
- Study design
- Small randomized, double-blind, placebo-controlled imaging-endpoint trial
- Funding
- NIH grants listed by PubMed
The authors described the liver-fat result as preliminary and did not establish long-term clinical outcomes.
Read the original sourceCan Egrifta WR and Egrifta SV be handled as the same product?
Egrifta WR and Egrifta SV contain tesamorelin but differ in formulation, reconstitution, concentration, storage, and administration. The current WR label says not to substitute them volume for volume.
A community vial or an older study formulation does not automatically inherit the current WR product's handling or exposure record.
Egrifta WR label · HIV lipodystrophy
FDA prescribing information
Theratechnologies. Egrifta WR prescribing information, 2025.
Defines the adult HIV-lipodystrophy indication, states that tesamorelin is not a weight-loss medicine, separates WR from SV handling, and lists malignancy, pregnancy, pituitary-axis, IGF-1, fluid, glucose, hypersensitivity, and injection warnings.
- Participants / model
- Adults with HIV and lipodystrophy who have excess abdominal fat
- Treatment
- Prescription tesamorelin injection sold as Egrifta WR
- Study design
- Regulatory prescribing information
Long-term cardiovascular safety has not been established, and the label is not a general-obesity approval.
Read the original sourceIs IGF-1 itself the proven fat-mobilizing switch?
Tesamorelin is a GHRH analog that binds pituitary GHRH receptors and increases pulsatile endogenous growth-hormone release. Growth hormone then drives IGF-1 production and other downstream effects. The clinical trials show a net change in fat compartments; they do not isolate IGF-1 as the sole causal signal.
IGF-1 rises during treatment and is monitored for excessive elevation.
Egrifta WR label · HIV lipodystrophy
FDA prescribing information
Theratechnologies. Egrifta WR prescribing information, 2025.
Defines the adult HIV-lipodystrophy indication, states that tesamorelin is not a weight-loss medicine, separates WR from SV handling, and lists malignancy, pregnancy, pituitary-axis, IGF-1, fluid, glucose, hypersensitivity, and injection warnings.
- Participants / model
- Adults with HIV and lipodystrophy who have excess abdominal fat
- Treatment
- Prescription tesamorelin injection sold as Egrifta WR
- Study design
- Regulatory prescribing information
Long-term cardiovascular safety has not been established, and the label is not a general-obesity approval.
Read the original sourceNon-HIV trial · selected obesity population
Randomized, double-blind trial
Makimura H et al. Journal of Clinical Endocrinology and Metabolism, 2012.
In 60 adults with abdominal obesity and reduced GH secretion, tesamorelin reduced visceral-fat area versus placebo over 12 months, without a significant subcutaneous-fat change.
- Participants / model
- Adults with abdominal obesity and reduced GH secretion, without the HIV-lipodystrophy selection used for the approval
- Treatment
- Daily tesamorelin 2 mg or placebo
- Follow-up
- 12 months
- Study design
- Randomized, double-blind, placebo-controlled trial
- Funding
- NIH research support
Small selected-population study; it does not establish a broad obesity indication or long-term clinical outcome benefit.
Read the original sourceWhich risks follow from raising GH and IGF-1 signaling?
The current label warns about active malignancy, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, and injection-site reactions. Pregnancy and disruption of the hypothalamic-pituitary axis are contraindications. The drug increases endogenous GH release, which then raises IGF-1.
- Active malignancy is a contraindication; prior malignancy requires careful risk assessment.
- Treatment requires monitoring of IGF-1 and blood glucose.
- Swelling, joint discomfort, carpal-tunnel symptoms, hypersensitivity, and injection reactions can occur during treatment.
Egrifta WR label · HIV lipodystrophy
FDA prescribing information
Theratechnologies. Egrifta WR prescribing information, 2025.
Defines the adult HIV-lipodystrophy indication, states that tesamorelin is not a weight-loss medicine, separates WR from SV handling, and lists malignancy, pregnancy, pituitary-axis, IGF-1, fluid, glucose, hypersensitivity, and injection warnings.
- Participants / model
- Adults with HIV and lipodystrophy who have excess abdominal fat
- Treatment
- Prescription tesamorelin injection sold as Egrifta WR
- Study design
- Regulatory prescribing information
Long-term cardiovascular safety has not been established, and the label is not a general-obesity approval.
Read the original sourceStudies and sources
Egrifta WR label · HIV lipodystrophy
FDA prescribing information
Theratechnologies. Egrifta WR prescribing information, 2025.
Defines the adult HIV-lipodystrophy indication, states that tesamorelin is not a weight-loss medicine, separates WR from SV handling, and lists malignancy, pregnancy, pituitary-axis, IGF-1, fluid, glucose, hypersensitivity, and injection warnings.
- Participants / model
- Adults with HIV and lipodystrophy who have excess abdominal fat
- Treatment
- Prescription tesamorelin injection sold as Egrifta WR
- Study design
- Regulatory prescribing information
Long-term cardiovascular safety has not been established, and the label is not a general-obesity approval.
Read the original sourceFalutz trial · HIV visceral fat
Randomized, placebo-controlled trial
Falutz J et al. New England Journal of Medicine, 2007.
In 412 adults with HIV and abdominal-fat accumulation, CT-measured visceral fat changed -15.2% with tesamorelin and +5.0% with placebo at 26 weeks.
- Participants / model
- Adults with HIV and treatment-associated central fat accumulation; 86% men
- Treatment
- Daily subcutaneous tesamorelin 2 mg or placebo
- Follow-up
- 26 weeks
- Study design
- Randomized, placebo-controlled trial
- Funding
- Theratechnologies
The primary endpoint was visceral-fat imaging, not body weight or a cardiovascular event.
Read the original sourceNon-HIV trial · selected obesity population
Randomized, double-blind trial
Makimura H et al. Journal of Clinical Endocrinology and Metabolism, 2012.
In 60 adults with abdominal obesity and reduced GH secretion, tesamorelin reduced visceral-fat area versus placebo over 12 months, without a significant subcutaneous-fat change.
- Participants / model
- Adults with abdominal obesity and reduced GH secretion, without the HIV-lipodystrophy selection used for the approval
- Treatment
- Daily tesamorelin 2 mg or placebo
- Follow-up
- 12 months
- Study design
- Randomized, double-blind, placebo-controlled trial
- Funding
- NIH research support
Small selected-population study; it does not establish a broad obesity indication or long-term clinical outcome benefit.
Read the original sourceExtension trial · visceral-fat reaccumulation
Randomized withdrawal extension
Falutz J et al. AIDS, 2008.
Visceral-fat reduction was sustained through 52 weeks with continued tesamorelin, while visceral fat reaccumulated after switching from tesamorelin to placebo.
- Participants / model
- Adults with HIV and central fat accumulation who entered the extension after the initial randomized phase
- Treatment
- Continue tesamorelin or switch to placebo after 26 weeks
- Follow-up
- 52 weeks total
- Study design
- Randomized treatment-extension and withdrawal study
- Funding
- Theratechnologies
Participants entered the extension after completing the initial 26-week trial.
Read the original sourceJAMA trial · preliminary liver-fat result
Randomized, double-blind, placebo-controlled trial
Stanley TL et al. JAMA, 2014.
Fifty antiretroviral-treated adults with HIV and abdominal fat accumulation were randomized and 48 received study drug. At six months, the net treatment difference was -42 cm2 for visceral-fat area and -2.9 percentage points for liver-fat fraction.
- Participants / model
- Men and women with HIV, abdominal fat accumulation, and antiretroviral treatment
- Treatment
- Daily tesamorelin 2 mg or placebo
- Follow-up
- Six months
- Study design
- Small randomized, double-blind, placebo-controlled imaging-endpoint trial
- Funding
- NIH grants listed by PubMed
The authors described the liver-fat result as preliminary and did not establish long-term clinical outcomes.
Read the original sourceWhy is tesamorelin in S tier?
S tier reflects randomized trials and US approval for excess abdominal fat in adults with HIV and lipodystrophy. It is not approved for general weight management, and long-term cardiovascular safety has not been established.
read Tesamorelin in the reptides guide, chapter 09: 12 pages, free to read.