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Tes5.0
Tesamorelin – Forschung
Überwiegend Mechanismus / Beobachtung
16 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Tesamorelin sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus mittelwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2004–2026 mit einer typischen Studiengröße von 73 Teilnehmenden.
Basierend auf 16 Studien · 1 Meta-Analyse · 7 RCTs · 2,060 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Visceral fat & body compositionBei ART-behandelten HIV-Patienten mit übermäßigem Bauchfett sank das viszerale Fettgewebe über 26-52 Wochen um ~15-18 % gegenüber Placebo (nur in dieser Population nachgewiesen) · 26-52 Wochen
Überwiegend Mechanismus / Beobachtung10 Studien
Glucose & metabolic
Überwiegend Mechanismus / Beobachtung7 Studien
Liver healthEine RCT in Lancet HIV zeigte über 12 Monate eine relative Reduktion des Leberfettanteils um ~37 % (kleine Studien bei HIV-Patienten, keine zugelassene Indikation) · 6-12 Monate
Überwiegend Mechanismus / Beobachtung4 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung4 Studien
Cognitive function
Zu wenige bewertete Studien2 Studien
Aktives Forschungsgebiet
6 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2026
200420152026
1Systematische Übersicht2026
Conclusion : This narrative review attempts to detail the physiology of muscle mass loss when accompanied by weight loss and identify pharmacological targets that can be utilized to minimize it with mechanisms, effects, side effects, and research developmental progress.
Arora G, Conde KR, Desouza CV. · Journal of clinical medicine (2026)
Results : Weight loss, regardless of the method used to achieve it, is inadvertently accompanied by lean body mass loss, to varying degrees.
Most of these drugs are in the early phases of research development, but some show great promise.
Conclusion : This narrative review attempts to detail the physiology of muscle mass loss when accompanied by weight loss and identify pharmacological targets that can be utilized to minimize it with mechanisms, effects, side effects, and research developmental progress.
While there have been exciting advances to improve diagnosis and management of MASLD in the general population, differences in MASLD pathophysiology demonstrate the need to tailor our approach specifically for PWH.
Gattu AK, Fourman LT. · Current opinion in HIV and AIDS (2025)
Despite an expanding pipeline of MASLD therapies, a critical gap remains in evaluating these interventions specifically among PWH.
Nonetheless, dedicated studies of glucagon-like peptide-1 receptor agonists and the growth hormone-releasing hormone analog tesamorelin have shown promise in MASLD-HIV.
Summary MASLD is a key contributor to liver-related and cardiovascular-morbidity in PWH.
Despite the association of INSTI use with weight gain and adipose tissue dysfunction, tesamorelin had beneficial effects on body composition with no exacerbation of glycemic control.
Russo SC, Ockene MW, Arpante AK, Johnson JE, Lee H, Toribio M, Stanley TL, Hadigan CM, Grinspoon SK, Erlandson KM, Fourman LT. · AIDS (London, England) (2024)
Tesamorelin led to significant declines in visceral fat (median [interquartile range]: -25 [-93, -2] vs. 14 [3, 41] cm 2 , P = 0.001), hepatic fat (-4.2% [-12.3%, -2.7%] vs. -0.5% [-3.9%, 2.7%], P = 0.01), and trunk-to-appendicular fat ratio (-0.1 [-0.3, 0.0] vs. 0.0 [-0.1, 0.1], P = 0.03).
Tesamorelin was well tolerated with a similar frequency of adverse events, including hyperglycemia, between groups.
Conclusions The current analysis provides the first dedicated data on the efficacy and safety of tesamorelin among PWH on INSTI-based regimens.
This review summarizes these and other new findings and highlights new research directions for the neuro-HIV field.
Corley MJ, Letendre SL, Nightingale S. · Topics in antiviral medicine (2024)
Reports included new evidence from low- and middleincome countries, HIV persistence in the central nervous system, aging-related complications (including cerebrovascular disease), additional data relevant to pathogenesis, and therapeutics.
New therapeutic findings were presented on the cerebrospinal fluid inhibitory quotient, the effects of polypharmacy, and clinical trials of tesamorelin and telmisartan.
This review summarizes these and other new findings and highlights new research directions for the neuro-HIV field.
5Meta-Analysen=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