Tesamorelin is a synthetic analogue of growth hormone-releasing hormone (GHRH). It is one of the few peptides on this list with a current FDA label, and that label covers one use: reducing excess abdominal fat in adults with HIV-associated lipodystrophy. The human research is two trials of very different size and purpose, and both are short.
The HIV trial
Falutz and colleagues randomized 412 adults with HIV and excess abdominal fat, most of them men (86%), to 2 mg of tesamorelin under the skin every day or to placebo for 26 weeks (N Engl J Med 2007; NCT00123253). The main outcome was visceral fat measured by CT scan at the L4-L5 level. Visceral fat fell 15.2% on tesamorelin, and the placebo group did not come close.
The same trial measured lipids and glucose. Triglycerides fell about 50 mg/dL on tesamorelin and rose about 9 mg/dL on placebo, and the ratio of total to HDL cholesterol fell. IGF-I rose 81.0% on tesamorelin and fell 5.0% on placebo. No significant difference in glucose or insulin was found. More people on tesamorelin withdrew from the study because of an adverse event, although overall adverse-event rates did not differ significantly.
What the label adds
The FDA label for EGRIFTA WR and SV (revised March 2025) reports two 26-week studies of this design. Visceral fat fell by about 18% in one and about 14% in the other, with the confidence intervals given in the label. The label also describes a 52-week extension, in which people who stayed on treatment were followed for a second year. Those extension figures are in the label and are not repeated here.
The label's visceral-fat percentages are a little different from the abstract's, so the number to use is 'about 15%', which sits between the two label studies and the paper.
Cognition in older adults
Baker and colleagues (Arch Neurol 2012) tested tesamorelin in a different group: 152 adults aged 55 to 87, 66 with mild cognitive impairment and the rest healthy. They injected 1 mg at bedtime or placebo for 20 weeks, and 137 completed the study. Across all participants, cognition improved more on tesamorelin (intent-to-treat P = 0.03), and the executive-function result was clearer (P = 0.005). The verbal-memory result was only a trend (P = 0.08).
IGF-1 rose 117% on tesamorelin but stayed within the physiological range. Percent body fat fell 7.4%. Fasting insulin rose 35%, but only in the MCI group. Adverse events were mild and were reported by 68% of people on tesamorelin and 36% on placebo.
Safety and the label's warnings
- The label lists an increased risk of neoplasms. Any existing cancer must be inactive, and treatment is stopped if a malignancy recurs. Active malignancy is a contraindication.
- IGF-I rises during treatment. The label says the effects of prolonged elevation are unknown and asks for periodic IGF-I checks.
- Glucose intolerance and diabetes can develop. The label asks for glucose checks before and during therapy.
- Contraindications include pregnancy, known hypersensitivity to tesamorelin, and disruption of the hypothalamic-pituitary axis.
- The most common adverse reactions in the label include arthralgia (joint pain) and injection-site reactions.
What is approved, and what is not
The indication is narrow: reducing excess abdominal fat in HIV-infected adults with lipodystrophy. The label says the drug is not indicated for weight loss because it has a weight-neutral effect, and it says long-term cardiovascular safety has not been established. Use for weight, longevity or general cognition is outside the label.
What this does not say
- None of these trials measured heart attacks, stroke, deaths, fractures, or quality of life over years. The label states that long-term cardiovascular safety is not established.
- The cognition trial lasted 20 weeks and reported test performance. It was not designed to show that cognitive decline is prevented or slowed, and daily function is not among the outcomes reported in its abstract.
- Compounded or research-grade tesamorelin was not studied, and the blend with ipamorelin was not tested as a combination.
How we use this
Our physicians treat the label as the boundary. We do not present tesamorelin as a weight-loss or longevity treatment, because the label does not support either use and the cognition result comes from one small trial.
When it is considered for someone with HIV-associated abdominal fat, the points to discuss are the ones in the label: IGF-1 and glucose monitoring, cancer history and cardiovascular risk. Trial results are averages and do not predict what will happen to you.
Explore weight loss treatmentsSources
- 1.Falutz J, Allas S, Blot K, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357:2359-2370. New England Journal of Medicine
- 2.Baker LD, Barsness SM, Borson S, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults. Arch Neurol. 2012;69(11):1420-1429. Archives of Neurology
- 3.Baker LD et al., full text (PMC3764914). PubMed Central
- 4.Falutz J et al., abstract (PubMed 18057338). PubMed
- 5.EGRIFTA WR and EGRIFTA SV (tesamorelin) prescribing information, revised March 2025. U.S. Food and Drug Administration