Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials

BACKGROUND: HIV-associated lipodystrophy leads to visceral fat accumulation, metabolic complications, body image concerns, medication non-adherence, and increased cardiovascular risks. We thought to assess the effects of Tesamorelin, a synthetic growth hormone-releasing hormone analogue, that has been proposed as a targeted therapy. METHODS: We systematically searched PubMed, Embase, Scopus, Web of Science, and CENTRAL through July 2025 for randomized controlled trials (RCTs) evaluating Tesamorelin versus placebo in adults with HIV. Random-effects meta-analysis was applied. Outcomes included changes in body composition, hepatic and metabolic parameters, hormonal markers, and adverse events. Risk of bias was assessed with RoB 2.0, and certainty of evidence with GRADE. RESULTS: Five RCTs evaluating Tesamorelin were included in the analysis. Tesamorelin was associated with significant reduction in visceral adipose tissue (MD=-27.71ƒ__cmAý, 95ƒ__% CI [-38.37, -17.06]; Pƒ__<ƒ__0.001), trunk fat (MD=-1.18ƒ__kg, 95ƒ__% CI [-1.40, -0.96]; Pƒ__<ƒ__0.001), limb fat (MD=-0.22ƒ__kg, 95ƒ__% CI [-0.35, -0.08]; Pƒ__=ƒ__0.001), hepatic fat percentage (MD=-4.28ƒ__%, 95ƒ__% CI [-6.31, -2.24]; Pƒ__<ƒ__0.001), and waist circumference (MD=-1.61ƒ__cm, 95ƒ__% CI [-2.28, -0.95]; Pƒ__<ƒ__0.001). A significant increase in lean body mass was observed (MD=1.42ƒ__kg, 95ƒ__% CI [1.13, 1.71]; Pƒ__<ƒ__0.001). However, no significant reductions in subcutaneous adipose tissue or BMI were observed. Tesamorelin showed no significant change in CD4ƒ__+ƒ__T-cell counts. Tesamorelin was associated with adverse events, including arthralgia, myalgia, paresthesia, and injection-site reactions like erythema. CONCLUSION: Tesamorelin improves body composition, hepatic fat, lean body mass, and IGF-1 levels in HIV-associated lipodystrophy, without serious side effects or perturbation of glucose

• Population(s)
  • General HIV+ population
• Co-morbidities
  • Other