Tesamorelin is sold as Egrifta, an approved growth-hormone-releasing-hormone analogue, and clinics advertise it to women for belly fat. The question this page answers is narrow: what the record says about women specifically. The short answer is that women were in the trials, at roughly one participant in seven, and their results were never published as a separate finding.
The overall trial results — the 26-week visceral-fat drop, what happened when treatment stopped, who did not respond — are on our tesamorelin results page; harms on our tesamorelin side effects page. What tesamorelin is, in plain terms, is in Peptide Lexicon's tesamorelin entry, and MuscleLedger covers it for training readers on its tesamorelin compound page. Nothing here is a recommendation.
What the label approves, for anyone
The Egrifta WR label (Theratechnologies, DailyMed, effective 29 July 2026, read 22 October 2026) approves tesamorelin "for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." The indication does not distinguish men from women, and it covers no one without HIV. The label also notes that long-term cardiovascular safety has not been established.
Who the trials enrolled
The approval rests on two randomised, placebo-controlled 26-week studies, each followed by a 26-week extension. Women had their own entry thresholds:
| Entry criterion | Men | Women |
|---|---|---|
| Waist circumference | ≥ 95 cm | ≥ 94 cm |
| Waist-to-hip ratio | ≥ 0.94 | ≥ 0.88 |
| Fasting glucose | < 150 mg/dL | < 150 mg/dL |
And this is who came in, from the label's baseline descriptions:
| Trial phase | Participants | Men | Women (our arithmetic) |
|---|---|---|---|
| Study 1, main phase | 410 | 86% | ~57 (14%) |
| Study 2, main phase | 396 | 84% | ~63 (16%) |
| Extension (re-randomised) | 204 | 88% | ~24 (12%) |
The label reports the visceral-fat result pooled: in study 1, −18% with tesamorelin against +2% with placebo at 26 weeks; in study 2, −14% against −2%. Neither the label nor any published trial read for this page reports that result for women alone. About 120 women received tesamorelin or placebo across the two pivotal trials, split 2:1 — a group too small to have been powered for a separate answer, and none was published.
A pooled analysis of both trials by the drug's sponsors (Mangili 2015, PLoS One) looked for predictors of response. It controlled for sex rather than reporting it as a predictor; the factors it did identify were metabolic syndrome, triglycerides above 1.7 mmol/L and white race. Its authors included employees of EMD Serono and Theratechnologies.
Trials outside the pivotal pair
Several later trials enrolled both sexes without publishing results by sex in their abstracts:
- Liver fat — 50 men and women with HIV, six months (Stanley 2014, JAMA): visceral fat −34 cm² against +8 cm², and a net −2.9% liver fat.
- Obesity without HIV — 60 abdominally obese adults with reduced growth hormone secretion, twelve months (Makimura 2012, JCEM): visceral fat −16 cm² against +19 cm², with improved triglycerides and C-reactive protein and no change in glucose. This is the one controlled trial in people without HIV, and it is off-label territory.
- Cognition in older adults — 152 adults aged 55 to 87, twenty weeks at 1 mg a day (Baker 2012, Arch Neurol): a favourable effect on executive function, IGF-1 up 117% and body fat down 7.4%; adverse events in 68% on tesamorelin against 36% on placebo.
None of these reports a result for women separately in the material read. Each is the place to look if a sex-specific analysis is ever published.
Does sex change the drug's action?
The one analysis that tested it directly is pharmacokinetic. A population model built from people with HIV and healthy volunteers evaluated age, weight, BMI, sex, race and health status, and found that "no covariates were significantly associated" with the growth hormone or IGF-1 model parameters (González-Sales 2015, J Pharmacokinet Pharmacodyn). That says the hormone response does not differ measurably by sex within the range studied; it does not say the fat result is the same.
A 2013 review of growth hormone in ageing (Sattler 2013) focused on men "since women appear more resistant to treatment." That remark concerns growth hormone augmentation in general. It is a reason the question is worth asking, not evidence of a tesamorelin difference.
Pregnancy and breastfeeding
This is the one place the label speaks to women directly:
- Pregnancy: contraindicated. "Modifying visceral adipose tissue offers no benefit in pregnant women and could result in fetal harm." In rats given tesamorelin during organogenesis, offspring had hydrocephaly at about two and four times clinical exposure; lower exposures delayed skull ossification. The label advises stopping if pregnancy occurs.
- Breastfeeding: not advised. The label tells mothers receiving it not to breastfeed, citing HIV transmission and the potential for serious adverse reactions in the infant, and states there are no data on tesamorelin in human milk.
- Fertility: the label reports no effect on fertility in male or female rats at roughly clinical exposure; there are no human fertility data.
Side-effect reports by sex
An openFDA query of FDA's adverse event database on 28 September 2026 returned 1,586 reports naming tesamorelin; where sex was recorded, 357 were men and 66 women. That ratio follows who is prescribed Egrifta — mostly men with HIV — and says nothing about whether women have more or fewer side effects per person treated. The full record is on our side effects page.
Tesamorelin for men
Men are the population the evidence describes: 84–88% of participants in every phase of the label's trials, and five in six adverse event reports with a recorded sex. In practice, the results on our tesamorelin results page are results in men with HIV. How tesamorelin compares with other growth-hormone peptides is on our tesamorelin vs ipamorelin page.
What is not established
- The visceral-fat effect in women as a separate result — not reported in the label or any trial read.
- Any effect in women without HIV beyond their share of the 60-person obesity trial.
- Use around menopause, when visceral fat typically rises — no trial located studied it.
- Human pregnancy and lactation data — none exist; the contraindication rests on the absence of benefit and rat findings.
Any decision about tesamorelin belongs with the prescribing clinician, who can weigh it against the label's contraindications.
Sources and dates
- Egrifta WR (tesamorelin) label, Theratechnologies, DailyMed set 839334d3-8c1d-4c26-9036-2ab524a6ea75, effective 29 July 2026 — read 22 October 2026 (indication, entry criteria, baseline demographics, results, pregnancy, lactation, fertility).
- Mangili A et al. PLoS One 2015;10:e0140358 (PMID 26457580); Stanley TL et al. JAMA 2014;312(4):380–9 (PMID 25038357); Makimura H et al. J Clin Endocrinol Metab 2012;97(12):4769–79 (PMID 23015655); Baker LD et al. Arch Neurol 2012;69(11):1420–9 (PMID 22869065); González-Sales M et al. J Pharmacokinet Pharmacodyn 2015;42(3):287–99 (PMID 25895899); Sattler FR. Best Pract Res Clin Endocrinol Metab 2013;27(4):541–55 (PMID 24054930) — abstracts read 22 October 2026.
- openFDA FAERS tesamorelin query, 28 September 2026 (data updated 30 July 2026), as reported on our side effects page.