Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 41545261 · doi:10.1016/j.orcp.2026.01.002
What was done
A systematic review and random-effects meta-analysis of randomized controlled trials (RCTs) searched PubMed, Embase, Scopus, Web of Science, and CENTRAL through July 2025. The study compared tesamorelin (a synthetic growth hormone-releasing hormone analogue) against placebo in adults with HIV-associated lipodystrophy. Assessed outcomes included body composition, hepatic fat, metabolic parameters, CD4+ T-cell counts, and adverse events. Risk of bias was evaluated with RoB 2.0 and certainty with GRADE.
What was found
Five RCTs were included. Tesamorelin produced significant reductions 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). Lean body mass increased significantly (MD = 1.42 kg, 95% CI [1.13, 1.71]; P < 0.001). No significant changes were observed in subcutaneous adipose tissue, BMI, or CD4+ T-cell counts. Tesamorelin was associated with adverse events including arthralgia, myalgia, paresthesia, and injection-site erythema.
Why it matters
This synthesis confirms that tesamorelin selectively reduces visceral and liver fat while increasing lean mass in HIV-associated lipodystrophy without impairing immune status or glycemic control.
Limits
The review included only five RCTs, and the total participant sample size was not reported in the abstract. Tesamorelin led to a small decrease in limb fat and failed to improve subcutaneous fat or overall BMI. Treatment was also associated with musculoskeletal and injection-site adverse effects, and hard cardiovascular outcomes were not evaluated.
Cited by
- supports Tesamorelin stimulates growth hormone release and is uniquely effective at reducing visceral abdominal fat.