Meta-analysis of RCTs · PMID 41545261
Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials — VialBase Research
5 RCTs included; tesamorelin vs placebo in HIV adults
Last updated · 2026 · Badran AS, Helal A, Shata KS, Ayesh H · Obesity Research & Clinical Practice
Key findings
- 5 RCTs included; tesamorelin vs placebo in HIV adults
- Significant reduction in visceral adipose tissue (MD=-27.71 cm2, P<0.001)
- Trunk fat reduced (MD=-1.18 kg), hepatic fat reduced (MD=-4.28%)
- Lean body mass increased (MD=+1.42 kg, P<0.001)
- No significant change in subcutaneous fat, BMI, or CD4+ counts
- Adverse events: arthralgia, myalgia, paresthesia, injection site reactions
PMID 41545261 — Tesamorelin HIV Lipodystrophy Meta-Analysis
Compound: Tesamorelin Citation: Badran AS et al. Obes Res Clin Pract. 2026;20(1):2-12. doi:10.1016/j.orcp.2026.01.002
Summary
Systematic review and meta-analysis of 5 randomized controlled trials evaluating tesamorelin versus placebo in adults with HIV-associated lipodystrophy. Searched PubMed, Embase, Scopus, Web of Science, and CENTRAL through July 2025. Risk of bias assessed with RoB 2.0; certainty of evidence with GRADE.
Key Results
| Outcome | Mean Difference | 95% CI | P value |
|---|---|---|---|
| Visceral adipose tissue | -27.71 cm2 | [-38.37, -17.06] | <0.001 |
| Trunk fat | -1.18 kg | [-1.40, -0.96] | <0.001 |
| Limb fat | -0.22 kg | [-0.35, -0.08] | 0.001 |
| Hepatic fat % | -4.28% | [-6.31, -2.24] | <0.001 |
| Waist circumference | -1.61 cm | [-2.28, -0.95] | <0.001 |
| Lean body mass | +1.42 kg | [1.13, 1.71] | <0.001 |
| Subcutaneous fat | NS | — | NS |
| BMI | NS | — | NS |
Safety
- No serious adverse events
- Common: arthralgia, myalgia, paresthesia, injection site erythema
- No significant change in CD4+ T-cell counts
- No perturbation of glucose metabolism
Clinical Significance
Strongest evidence base for tesamorelin’s primary indication. Demonstrates selective visceral fat reduction with concurrent lean mass gain — a unique and clinically valuable body composition effect.
See Also
- Parent compound: Tesamorelin