Gathering the record
Relay is organizing the evidence and source boundaries.
Growth hormone–releasing hormone (GHRH) analog
A drug used to reduce excess deep belly fat in adults with HIV-related changes in fat distribution. It is not a general weight-loss drug.
Evidence is explained by question. Dosing references show their own check dates.
60-second overview
Why people look into it, what studies found, and what is still unknown.
Educational information only. Evidence reviewed through July 25, 2026. Published studies, sponsor announcements, and trials without results are labeled separately. Evidence gaps apply to the specific finding beside them.
Research questions
Each label shows how much evidence supports that question.
What studies show
Two randomized Phase 3 trials enrolling 816 adults with HIV-associated abdominal fat accumulation found meaningful reductions in CT-measured visceral fat over 26 weeks, with effects maintained during continued treatment in extension data.
Tesamorelin is a synthetic 44-amino-acid GHRH analog. It stimulates the body’s own growth-hormone axis rather than acting as injected growth hormone.
The strongest evidence is in adults with HIV and lipodystrophy who had excess abdominal fat. The measured outcome was visceral fat—not general weight loss.
Current U.S. labeling covers reduction of excess abdominal fat in adults with HIV and lipodystrophy. The label describes tesamorelin as weight neutral.
The 52-week extension supports on-treatment durability, while participants switched to placebo regained visceral fat.
This is early, condition-specific human evidence for a research area outside the FDA-approved indication.
Tesamorelin did not significantly improve the primary neurocognitive outcome versus standard care over six months.
The labels address elevated IGF-1, glucose intolerance or diabetes, fluid retention, hypersensitivity, injection-site reactions, and malignancy-related precautions.
Risks & unknowns
Current labels identify clinically important risks and monitoring boundaries.
Controlled human evidenceThis is not a complete safety assessment or individualized medical guidance; the current prescribing information is the controlling source.
Open sourceCurrent labels identify clinically important risks and monitoring boundaries.
Controlled human evidenceThis is not a complete safety assessment or individualized medical guidance; the current prescribing information is the controlling source.
Open sourceThe available information does not reliably show how often particular side effects occur.
Evidence boundaryUnder-detected or under-reported events must not be described as rare.
The visceral-fat reduction was sustained at about 18% among participants who continued treatment for 52 weeks. The effect was lost after participants switched from tesamorelin to placebo.
Controlled human evidenceStudy discontinuation describes what happened under a study protocol; it is not an emergency-action threshold.
Open sourceThis profile does not contain verified, product-specific emergency instructions.
Evidence boundaryRelay does not infer emergency guidance from study discontinuations, mechanism, or incomplete adverse-event reporting.
Dosing references
Each table labels its source and applies only to the named route, product, or study. An online example or community report is not an approved dose.
Instructions from the named approved product’s prescribing information. They apply to its stated formulation, route, use, and population.
EGRIFTA WR is labeled for excess abdominal fat in adults with HIV-associated lipodystrophy. It is not indicated for general weight-loss management.
| Product reference | Label detail | Scope |
|---|---|---|
| Dose | 1.28 mg in 0.16 mL, once daily subcutaneously | EGRIFTA WR |
| Reconstitution | 1.3 mL of the supplied bacteriostatic water; label concentration 8 mg/mL | Exact 11.6 mg WR presentation |
| After mixing | Store at 20–25°C; discard after 7 days; do not freeze | Product-specific storage |
EGRIFTA WR and EGRIFTA SV are not substitutable. Follow the complete product Instructions for Use, including mixing and inspection steps.
FDA · EGRIFTA WR label, sections 1–2 and Instructions for Use This reference checked Oct 20, 2026. The full-profile review date is shown at the top.These quantities belong only to EGRIFTA WR. Its labeled concentration is product-defined; do not substitute a generic powder-vial calculation or apply these instructions to other tesamorelin products.
Concentration = total mass ÷ final volume. The calculator performs user-entered math; it does not choose a dose or diluent.
Open concentration calculatorStarting dose: the amount used at the beginning of the named label schedule or trial.
Maintenance: the ongoing amount described by that product label.
Trial target: the amount assigned to a study group. Different groups may stop increasing at different targets.
Current FDA labeling describes EGRIFTA WR for a narrow HIV-associated indication using its own supplied presentation and handling instructions.
Population: Adults with HIV and excess abdominal fat within the labeled indication
Design: Regulatory product labeling supported by controlled human trials
Mechanisms
Tesamorelin is a synthetic 44-amino-acid analog of human growth hormone–releasing hormone with an N-terminal modification that improves stability. It activates GHRH receptors on pituitary somatotroph cells, increasing endogenous pulsatile growth-hormone release and downstream IGF-1. Human evidence is strongest for visceral-fat reduction in HIV-associated lipodystrophy. Smaller studies address HIV-associated liver fat and cognition; those findings do not create additional approved indications.
A plausible mechanism can explain why a study was attempted. It does not prove that the compound improves a human outcome.
Research reference
A reference for the studies, populations, and routes behind this profile.
Two Phase 3 trials, extension data, current FDA labels, and additional condition-specific human studies.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Visceral-fat reduction is well supported in adults with HIV-associated lipodystrophy; evidence outside that population is much narrower.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not an instruction for an individual.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: EGRIFTA WR and EGRIFTA SV are not substitutable presentations. The WR label's supplied diluent, 11.6 mg vial, concentration, and seven-dose handling instructions do not establish instructions for a generic 10 mg vial. Amounts shown describe cited research exposure—not a dosage recommendation.
Studies
Study arms are reported for transparency. They describe what researchers did in a defined record and do not transfer across identities, routes, formulations, or populations.
A later trial phase can ask a more mature question, but it does not guarantee a positive result, regulatory approval, or relevance outside the studied population.
Randomized 3:2, open-label, controlled trial of tesamorelin plus standard care versus standard care
Adults with HIV, abdominal obesity, and neurocognitive impairment
The trial did not find a statistically significant between-group improvement in the primary neurocognitive outcome. Waist circumference decreased more in the tesamorelin group.
Study administration: Once-daily subcutaneous tesamorelin under the trial protocol plus standard care, or standard care alone
Limitations: Open-label, no placebo injection, short duration, and smaller-than-planned enrollment. The study does not support a claim that tesamorelin improves cognition.
Randomized, double-blind, multicenter, placebo-controlled trial
Adults with HIV and MRI-defined non-alcoholic fatty liver disease
Tesamorelin reduced hepatic fat fraction versus placebo, with an absolute treatment effect of −4.1 percentage points. Thirty-five percent of tesamorelin participants versus 4% of placebo participants reached liver fat below 5%.
Study administration: Once-daily subcutaneous tesamorelin 2 mg or placebo under the study protocol
Limitations: Small, condition-specific trial in people with HIV. It was not designed to establish tesamorelin as an approved NAFLD or MASLD treatment, and longer-term liver outcomes remain uncertain.
Pooled analysis of two multicenter, randomized, double-blind, placebo-controlled trials
Adults with HIV receiving antiretroviral therapy who had excess abdominal fat
Across the two trials, tesamorelin reduced visceral abdominal fat while body weight changed little. The FDA label reports mean VAT changes of −18% versus +2% in Study 1 and −14% versus −2% in Study 2 at 26 weeks.
Study administration: Once-daily subcutaneous tesamorelin 2 mg or placebo in the historical Phase 3 formulation and protocol
Limitations: Participants had HIV-associated abdominal fat accumulation, so the results do not establish general obesity treatment. The trials used an earlier 2 mg formulation; current EGRIFTA SV and WR labels are formulation-specific.
Blinded 26-week extension after an initial randomized, placebo-controlled 26-week trial
Adults with HIV and central fat accumulation in the context of antiretroviral therapy
The visceral-fat reduction was sustained at about 18% among participants who continued treatment for 52 weeks. The effect was lost after participants switched from tesamorelin to placebo.
Study administration: Participants continuing historical tesamorelin 2 mg daily, switching from tesamorelin to placebo, or switching from placebo to tesamorelin
Limitations: Extension analyses included fewer participants than the initial randomized phase and do not establish multi-year cardiovascular safety or durability after long-term discontinuation.
Subgroup analysis of the randomized HIV-associated NAFLD trial, stratified by integrase-inhibitor use
Participants with HIV and hepatic steatosis who were receiving an integrase inhibitor at baseline
Among the 31 subgroup participants who completed 12 months, median VAT changed by −25 cm² with tesamorelin versus +14 cm² with placebo, and liver fat changed by −4.2 versus −0.5 percentage points.
Study administration: Once-daily subcutaneous tesamorelin 2 mg or placebo under the parent study protocol
Limitations: Small secondary subgroup analysis rather than a separately powered trial. It does not create a new indication or establish results for all modern antiretroviral regimens.
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