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

Tesamorelin significantly reduced visceral adipose tissue in HIV-associated lipodystrophy.

• Mean difference of -27.71 cm², 95% CI [-38.37, -17.06], P < 0.001
• Analysis based on 5 RCTs using random-effects meta-analysis
• Risk of bias assessed with RoB 2.0 and certainty of evidence with GRADE

Tesamorelin significantly reduced trunk fat in HIV-associated lipodystrophy.

• Mean difference of -1.18 kg, 95% CI [-1.40, -0.96], P < 0.001
• Reduction was statistically significant across the included RCTs

Tesamorelin significantly reduced limb fat in HIV-associated lipodystrophy.

• Mean difference of -0.22 kg, 95% CI [-0.35, -0.08], P = 0.001
• Despite the reduction in limb fat, no significant reduction in subcutaneous adipose tissue or BMI was observed

Tesamorelin significantly reduced hepatic fat percentage in HIV-associated lipodystrophy.

• Mean difference of -4.28%, 95% CI [-6.31, -2.24], P < 0.001
• Hepatic fat was among the metabolic parameters evaluated in the meta-analysis

Tesamorelin significantly reduced waist circumference in HIV-associated lipodystrophy.

• Mean difference of -1.61 cm, 95% CI [-2.28, -0.95], P < 0.001
• Waist circumference was assessed as part of body composition outcomes

Tesamorelin significantly increased lean body mass in HIV-associated lipodystrophy.

• Mean difference of +1.42 kg, 95% CI [1.13, 1.71], P < 0.001
• This was a statistically significant improvement in lean body mass across the included trials

Tesamorelin did not produce significant reductions in subcutaneous adipose tissue or BMI.

• No significant change was observed for subcutaneous adipose tissue
• No significant change was observed for BMI
• These findings contrast with the significant reductions seen in visceral and trunk fat

Tesamorelin showed no significant change in CD4+ T-cell counts, indicating no perturbation of immune status.

• CD4+ T-cell counts were assessed as a safety and immunological outcome
• No significant change was detected across the 5 included RCTs

Tesamorelin was associated with adverse events including arthralgia, myalgia, paresthesia, and injection-site reactions such as erythema.

• These adverse events were identified across the 5 included RCTs
• No serious adverse effects were reported
• Glucose levels were not significantly perturbed by Tesamorelin treatment

The meta-analysis included five RCTs evaluating Tesamorelin versus placebo in adults with HIV.

• Databases searched included PubMed, Embase, Scopus, Web of Science, and CENTRAL through July 2025
• Only randomized controlled trials were included
• Outcomes included changes in body composition, hepatic and metabolic parameters, hormonal markers, and adverse events
• Random-effects meta-analysis was applied

Tesamorelin improved IGF-1 levels in HIV-associated lipodystrophy.

• IGF-1 was assessed as a hormonal marker outcome
• Improvement in IGF-1 levels was observed alongside improvements in body composition and hepatic fat