Source comparison
Top Tesamorelin Studies: Evidence Comparison
Falutz et al., Lancet 2010 Phase 3 RCT, 26 weeks 412 HIV+ adults with abdominal obesity Percent change in VAT (CT) −15.2% VAT vs −4.5% placebo; treatment effect 10.7% Established tesamorelin as the first FDA-approved therapy specifically for HIV-associated lip
This comparison does not assign a generated winner or score.
- Falutz et al., Lancet 2010
- Phase 3 RCT, 26 weeks
- 412 HIV+ adults with abdominal obesity
- Percent change in VAT (CT)
- −15.2% VAT vs −4.5% placebo; treatment effect 10.7%
- Established tesamorelin as the first FDA-approved therapy specifically for HIV-associated lipodystrophy
- Stanley et al., JAMA 2010
- 394 HIV+ adults with abdominal obesity
- −14.8% VAT; 67% achieved ≥8% reduction
- Replicated Lancet trial results in independent cohort, confirming consistency of effect
- Falutz et al., AIDS 2012
- Open-label extension, 52 weeks
- 332 patients from original trials
- VAT maintenance at week 52
- VAT reductions sustained through week 52; reaccumulation after discontinuation
- Demonstrated durability of effect with continuous use and reversibility after stopping
- Looby et al., CID 2012
- Mechanistic substudy
- 61 patients (subset of Phase 3)
- IGF-1, IGFBP-3, lipolytic markers
- IGF-1 increased 2.5× baseline; free fatty acid mobilization increased 18%
- Confirmed mechanism: pulsatile GH secretion drives selective visceral lipolysis without insulin resistance