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=-27.71 cm², 95 % CI [-38.37, -17.06]; P < 0.001), trunk fat (MD=-1.18 kg, 95 % CI [-1.40, -0.96]; P < 0.001), limb fat (MD=-0.22 kg, 95 % CI [-0.35, -0.08]; P = 0.001), hepatic fat percentage (MD=-4.28 %, 95 % CI [-6.31, -2.24]; P < 0.001), and waist circumference (MD=-1.61 cm, 95 % CI [-2.28, -0.95]; P < 0.001). A significant increase in lean body mass was observed (MD=1.42 kg, 95 % CI [1.13, 1.71]; P < 0.001). However, no significant reductions in subcutaneous adipose tissue or BMI were observed. Tesamorelin showed no significant change in CD4 + 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.