Protocol Reference
Tesamorelin
Tesamorelin — approved daily protocol in HIV-associated lipodystrophy
Summarise the protocol established by phase 3 trials and approved labelling for reducing excess visceral abdominal fat in a defined population.
FDA Approved for Specific IndicationReviewed September 1, 2026
Research Context
- Source of this information
- This is the only GHRH analogue protocol in this library backed by a current approved label. Its narrowness is instructive.
- Evidence level
- Grade A — two phase 3 randomised placebo-controlled trials and an approved label
- Population studied
- Adults with HIV and lipodystrophy with excess abdominal fat.
- Duration studied
- 26 weeks in the primary phase 3 analyses, with 52-week extension data.
- Route reported
- Subcutaneous injection, once daily
Protocol as Reported
- 01Labelling describes a fixed daily subcutaneous dose administered in the abdomen, with site rotation.
- 02Trial protocols specified reconstitution of lyophilised powder with sterile water immediately before administration.
- 03IGF-1 monitoring and periodic reassessment of continued benefit are described in labelling.
Adverse Events Reported
- Injection-site erythema and pruritus, arthralgia, peripheral oedema, myalgia.
- Raised IGF-1 and glucose intolerance; monitoring advised.
- Contraindicated in active malignancy per labelling.
Limitations
- Applies to a specific clinical population; the protocol was never validated in healthy adults.
- Visceral fat accumulates again after discontinuation.
Sources
- Prescribing label
Tesamorelin (Egrifta) prescribing information
- Randomised controlled trial
Tesamorelin phase 3 visceral adipose tissue trials
Educational reference only. Peptide Atlas does not provide medical advice or individualised dosing guidance, and nothing on this page should be used to guide personal use.