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Tes5.0
Tesamorelin Research
Mostly mechanism / observationalLimited safety
12 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Tesamorelin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from mixed-quality meta-analyses and randomised trials published 2004–2026 with a typical study size of 73 participants.
Based on 12 studies · 1 meta-analysis · 7 RCTs · 2,022 total participants
Confidence
High
By outcome
Visceral fat & body composition
Mostly mechanism / observational8 studies
Glucose & metabolic
Mostly mechanism / observational6 studies
Liver health
Mostly mechanism / observational3 studies
Cognitive function
Too few graded studies2 studies
Safety profile
Too few graded studies2 studies
Steady research
2 studies in the last 5 years · Latest meta-analysis: 2026
200420152026
1Meta-Analysisn=5 · very small study2026
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).
Badran AS, Helal A, Shata KS, Ayesh H. · Obes Res Clin Pract (2026)
Random-effects meta-analysis of 5 randomized controlled trials of tesamorelin vs placebo in adults with HIV-associated lipodystrophy (search through July 2025; risk of bias by RoB 2.0, certainty by GRADE)
Significant reductions in visceral adipose tissue (MD -27.71 cm2), trunk fat, hepatic fat percentage (MD -4.28%) and waist circumference, with a significant increase in lean body mass (MD +1.42 kg)
No significant change in subcutaneous adipose tissue, BMI, or CD4+ T-cell counts; adverse events were arthralgia, myalgia, paresthesia and injection-site reactions
Pooled analysis of two multicenter, double-blind, placebo-controlled phase-3 RCTs (n=806 ART-treated HIV patients with excess abdominal fat), randomized 2:1 to tesamorelin 2 mg or placebo subcutaneously daily
Visceral adipose tissue fell -15.4% vs placebo at 26 weeks; reductions in VAT, waist, triglycerides and cholesterol were maintained to 52 weeks in those continuing treatment
IGF-I rose (+108 ng/ml) and body-image / belly-profile ratings improved; generally well tolerated with no clinically meaningful glucose changes at 26 or 52 weeks
Tesamorelin reduces visceral fat by approximately 18% and improves body image distress in HIV-infected patients with central fat accumulation. The initial improvements over 6 months in VAT were rapidly lost in those switching from tesamorelin to placebo.
Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. · J Acquir Immune Defic Syndr (2010)
12-month phase-3 RCT in 404 ART-treated HIV patients with excess abdominal fat; randomized 2:1 to tesamorelin 2 mg sc daily or placebo, then rerandomized at 6 months
VAT decreased -10.9% with tesamorelin vs -0.6% with placebo over 6 months (P<0.0001); ~18% reduction in those continuing for 12 months
IGF-1 increased with no change in glucose parameters; trunk fat, waist circumference and waist-hip ratio improved with no change in limb/abdominal subcutaneous fat
Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo... corresponding to a -37% (95% CI -67 to -7, p=0·016) relative reduction from baseline.
Stanley TL, Fourman LT, Feldpausch MN, Purdy J, Zheng I, Pan CS, Aepfelbacher J, Buckless C, Tsao A, Kellogg A, Branch K, Lee H, Liu CY, Corey KE, Chung RT, Torriani M, Kleiner DE, Hadigan CM, Grinspoon SK. · Lancet HIV (2019)
Randomized, double-blind, placebo-controlled multicenter trial (n=61) in people with HIV and NAFLD (hepatic fat fraction ≥5%); tesamorelin 2 mg vs placebo daily for 12 months
Absolute liver-fat reduction of -4.1% (P=0.018), a -37% relative reduction; 35% of tesamorelin vs 4% of placebo reached HFF <5% (P=0.0069)
No between-group difference in fasting glucose or HbA1c at 12 months; more localized injection-site complaints with tesamorelin, none serious
Tesamorelin significantly reduced visceral adipose tissue... and liver fat... over 6 months, for a net treatment effect of -2.9% in lipid to water percentage.
Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK. · JAMA (2014)
Double-blind, placebo-controlled RCT (n=50) in ART-treated HIV men and women with abdominal fat accumulation; tesamorelin 2 mg vs placebo daily for 6 months
Fasting glucose rose transiently at 2 weeks (treatment effect +7 mg/dL, P=0.03) but 6-month glucose changes were not significant — illustrates the early glucose caveat
TH9507 resulted in dose-related physiological increases in IGF-I (P < 0.01 for 1 mg (+48%) and 2 mg (+65%) versus placebo).
Falutz J, Allas S, Kotler D, Thompson M, Koutkia P, Albu J, Trottier B, Routy JP, Cote P, Abribat T, Grinspoon S. · AIDS (2005)
Randomized, double-blind, placebo-controlled dose-ranging trial (n=61) of TH9507 (tesamorelin) 1 or 2 mg vs placebo subcutaneously daily for 12 weeks in HIV patients with central fat accumulation
Dose-related physiologic IGF-I increase (+48% at 1 mg, +65% at 2 mg); trunk fat fell -9.2% in the 2 mg group vs placebo (P=0.014)
Subcutaneous fat preserved; lean body mass and VAT:SAT ratio improved; triglycerides and cholesterol:HDL improved, glucose unchanged
The intent-to-treat analysis indicated a favorable effect of GHRH on cognition (P=.03), which was comparable in adults with MCI and healthy older adults.
Randomized, double-blind, placebo-controlled trial; 152 adults (66 with mild cognitive impairment) self-administered tesamorelin 1 mg/day or placebo subcutaneously before bedtime for 20 weeks
Favorable effect of GHRH on overall cognition (P=.03 ITT; P=.002 completers), driven by executive function (P=.005), with a verbal-memory trend (P=.08)
IGF-1 rose 117% (within physiologic range) and percent body fat fell 7.4%; fasting insulin rose in the MCI subgroup
Tesamorelin also reciprocally up- and downregulated curated gene sets associated with favorable and poor hepatocellular carcinoma prognosis, respectively.
Fourman LT, Billingsley JM, Agyapong G, Ho Sui SJ, Feldpausch MN, Purdy J, Zheng I, Pan CS, Corey KE, Torriani M, Kleiner DE, Hadigan CM, Stanley TL, Chung RT, Grinspoon SK. · JCI Insight (2020)
Mechanistic substudy of the Lancet HIV NAFLD RCT using paired liver biopsies to compare hepatic gene expression by treatment arm
Tesamorelin increased oxidative-phosphorylation gene sets and decreased gene sets for inflammation, tissue repair and cell division
Expression changes correlated with an improved fibrosis-related gene score, providing a mechanistic basis for the liver-fat / anti-fibrotic clinical effect
In November 2010, tesamorelin (Egrifta; Theratechnologies/EMD Serono), a growth hormone-releasing factor analogue, was approved by the US Food and Drug Administration for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Grunfeld C, Dritselis A, Kirkpatrick P. · Nat Rev Drug Discov (2011)
Drug-approval profile documenting the November 2010 FDA approval of tesamorelin (Egrifta) for reduction of excess abdominal fat in HIV-associated lipodystrophy
Confirms tesamorelin is an approved prescription medicine — distinguishing it from unapproved grey-market GHRH peptides
Summarizes the GHRH-analog mechanism and the approved indication
While tesamorelin reduced WC, the cognitive benefits did not significantly differ between groups... this study suggests no clear benefit of short-term AO reduction with tesamorelin on NCI.
Ellis RJ, Vaida F, Hu K, Dube M, Henry B, Chow F, Heaton RK, Lee D, Sattler F. · J Infect Dis (2025)
6-month phase-2 randomized, OPEN-LABEL trial (n=73, 3:2) comparing tesamorelin 2 mg/day vs standard of care for neurocognitive impairment in virally suppressed HIV patients with abdominal obesity
Tesamorelin group showed only a non-significant trend toward improved neurocognition (P=.060); no significant between-group difference (P=.673)
IGF-1 rose but did not correlate with cognitive change; tesamorelin did reduce waist circumference more than SOC (median difference -2.7 cm, P=.015)
A modified growth hormone releasing factor (GRF; TH9507), a 44 amino acid peptide analogue of natural human growth hormone releasing factor, is being developed for the treatment of age-associated conditions resulting from diminished growth hormone (GH) secretion.
Jansen M, Darby I, Abribat T, Dubreuil P, Ferdinandi ES, Hardy JG. · Int J Pharm (2004)
Preclinical pharmacokinetic study in beagle dogs comparing intratracheal, subcutaneous and intravenous TH9507 (tesamorelin) delivery
Inhaled bioavailability was 41% relative to subcutaneous; terminal half-life was short (~26-39 min) by both routes
Characterizes TH9507 as a 44-amino-acid GHRH analog and explored inhalation as an alternative to subcutaneous injection