Evidence comparison
Tesamorelin clinical evidence
What did tesamorelin studies actually measure, and what did they find? This page sets each study's reported result beside its design and limits. Studies with different populations and methods are kept separate.
By Tesamorelin.app editorial teamSources reviewed How we source
Visceral fat: the approved endpoint
Both pivotal phase 3 trials enrolled adults with HIV and excess abdominal fat. Their primary endpoint was visceral adipose tissue (VAT) measured by CT after 26 weeks. In Study 1 the mean difference from placebo was −31 cm² (95% CI −39 to −24). In Study 2 it was −21 cm² (95% CI −29 to −12)[1]. The label reports no meaningful difference in body weight in either trial[1].
In the extension phases, VAT stayed lower in patients who continued tesamorelin. It returned toward baseline in patients switched to placebo[1,3,4]. A post hoc analysis compared patients whose VAT fell by at least 8% with those whose VAT did not. The responders had different triglyceride and glucose results[5].
Liver fat: studied, not approved
Two randomized trials in people with HIV measured liver fat. In a single-centre study, the median change in liver lipid-to-water ratio was −2.0% with tesamorelin versus +0.9% with placebo over 6 months[6]. In a two-centre trial of people with HIV and at least 5% hepatic fat, the absolute difference in hepatic fat fraction at 12 months was −4.1 percentage points (95% CI −7.6 to −0.7)[7]. A later post hoc subgroup analysis looked at participants taking integrase inhibitors[8]. These results are not part of the approved indication.
Other populations
A 12-month randomized trial studied abdominal obesity without HIV. It reported a VAT difference of −35 cm² (95% CI −58 to −12)[9]. Cognitive outcomes have been studied in older adults[11] and in people with HIV[10]. The HIV cognition trial found no significant between-group difference. All of these populations fall outside the approved indication.
Published meta-analyses
Two meta-analyses of randomized trials in HIV-associated lipodystrophy were published in 2026[12,13]. Both pool overlapping sets of trials, and one reports high heterogeneity (I² = 74%) for VAT. This site reports their conclusions but does not calculate pooled estimates of its own.
Reported differences by endpoint
Each row is one study's own published estimate (tesamorelin minus placebo) with its 95% confidence interval. Rows are deliberately not combined.
Visceral adipose tissue, absolute change (cm²)
Negative = less visceral fat than placebo
| Study | Population | When | n | Difference (95% CI) | Source |
|---|---|---|---|---|---|
| Phase 3 Study 1 | HIV, abdominal fat | 26 weeks | 273 vs 137 | −31 (−39 to −24) | FDA label Table 2 (ITT, LOCF) · ref |
| Phase 3 Study 2 | HIV, abdominal fat | 26 weeks | 270 vs 126 | −21 (−29 to −12) | FDA label Table 2 (ITT, LOCF) · ref |
| Stanley 2014 | HIV, abdominal fat | 6 months | 50 randomized | −42 (−71 to −14) | ref |
| Makimura 2012 | Obesity, no HIV | 12 months | 60 | −35 (−58 to −12) | Outside the approved population · ref |
Compare studies side by side
Select two to four trials. Design features are shown next to results so differences in population and method stay visible.
| Attribute | Phase 3 Study 1 | Stanley 2014 (JAMA) | Stanley 2019 (Lancet HIV) |
|---|---|---|---|
| Registration | NCT00123253 | NCT01263717 | NCT02196831 |
| Phase | Phase 3 | Not applicable | Not applicable |
| Population | HIV: abdominal fat | HIV: abdominal fat | HIV: liver fat |
| In approved population | Yes | Yes | No |
| Enrolled | 412 | 54 | 61 |
| Design | Multicenter, randomized (2:1), double-blind, placebo-controlled, parallel; 26-week main phase followed by a 26-week re-randomized extension | Randomized, quadruple-masked, placebo-controlled, parallel | Randomized (1:1), double-blind (registry: quadruple), placebo-controlled, two sites, followed by a 6-month open-label phase |
| Control | Placebo | Placebo | Placebo |
| Duration | 52 weeks | 26 weeks | 52 weeks |
| Primary endpoint | Percent change from baseline in visceral adipose tissue (CT) at week 26 | Change in visceral adipose tissue and liver fat at 6 months | Change in hepatic fat fraction (1H-MRS) between baseline and 12 months |
| Key reported results |
|
|
|
| Evidence grade | High | Moderate | Moderate |
| Main limitation | More patients in the tesamorelin group withdrew because of an adverse event (NEJM abstract) | Authors call it a preliminary study; 50 randomized, 48 treated | 61 enrolled (30 vs 30 received study drug) |
References
- 1.EGRIFTA WR (tesamorelin) for injection, Prescribing Information. Revised 03/2025; DailyMed SPL version 2 (published 2026-08-03). DailyMed · accessed 2026-11-11
- 2.Falutz J, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357:2359-70. PubMed · PMID 18057338 · doi:10.1056/NEJMoa072375 · accessed 2026-11-11
- 3.Falutz J, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22:1719-28. PubMed · PMID 18690162 · doi:10.1097/QAD.0b013e32830a5058 · accessed 2026-11-11
- 4.Falutz J, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53:311-22. PubMed · PMID 20101189 · doi:10.1097/QAI.0b013e3181cbdaff · accessed 2026-11-11
- 5.Stanley TL, et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012;54:1642-51. PubMed · PMID 22495074 · doi:10.1093/cid/cis251 · accessed 2026-11-11
- 6.Stanley TL, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014;312:380-9. PubMed · PMID 25038357 · doi:10.1001/jama.2014.8334 · accessed 2026-11-11
- 7.Stanley TL, et al. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV. 2019;6:e821-e830. PubMed · PMID 31611038 · doi:10.1016/S2352-3018(19)30338-8 · accessed 2026-11-11
- 8.Russo SC, et al. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS. 2024;38:1758-1764. PubMed · PMID 38905488 · doi:10.1097/QAD.0000000000003965 · accessed 2026-11-11
- 9.Makimura H, et al. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab. 2012;97:4769-79. PubMed · PMID 23015655 · doi:10.1210/jc.2012-2794 · accessed 2026-11-11
- 10.Ellis RJ, et al. Effects of tesamorelin on neurocognitive impairment in persons with HIV and abdominal obesity. J Infect Dis. 2025;231:1230-1238. PubMed · PMID 39813152 · doi:10.1093/infdis/jiaf012 · accessed 2026-11-11
- 11.Baker LD, et al. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol. 2012;69:1420-9. PubMed · PMID 22869065 · doi:10.1001/archneurol.2012.1970 · accessed 2026-11-11
- 12.Ditta AM, et al. Efficacy and safety of tesamorelin in people living with HIV with lipodystrophy: a systematic review and meta-analysis. J Int Assoc Provid AIDS Care. 2026;25. PubMed · PMID 42538058 · doi:10.1177/23259582261475549 · accessed 2026-11-11
- 13.Badran AS, et al. Body composition, hepatic fat, metabolic, and safety outcomes of tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: a meta-analysis of randomized controlled trials. Obes Res Clin Pract. 2026;20:2-12. PubMed · PMID 41545261 · doi:10.1016/j.orcp.2026.01.002 · accessed 2026-11-11