# Tesamorelin Dosage in the Research Literature — Clinical Trial Data > Tesamorelin dosage as studied in clinical trials: 1–2 mg/day subcutaneous. Pharmacokinetics, half-life, reconstitution protocols, and route data from the peer-reviewed literature. ## Doses Studied in Clinical Trials Tesamorelin dosage in the clinical literature is concentrated at two levels: **2 mg/day subcutaneous** was used in the two pivotal FDA-approval trials (LIPO-010 and LIPO-011), in the 52-week extension (Falutz 2008 [2]), in the Phase II JAIDS trial (Falutz 2010 [3]), in the JAMA liver trial (Stanley 2014 [5]), in the Lancet HIV NAFLD trial (Stanley 2019 [6]), and in the 2024 INSTI cohort trial (Fourman 2024 [17]). **1 mg/day subcutaneous** was used in the Baker 2012 cognitive function trial (n=152, aged 55–87 years) [7] and in the lower-dose arm of the Clemmons 2017 type 2 diabetes safety trial. [11] All published trials administered tesamorelin via subcutaneous injection into the abdomen, with rotation of injection sites. No oral, intranasal, or intramuscular routes have been studied in published human trials. [9] ## Tesamorelin Half-Life and Pharmacokinetics A population pharmacokinetic analysis (González-Sales 2015 [9]) reported the following parameters: - Plasma terminal half-life: approximately 26–38 minutes - Plasma clearance (CL): approximately 1,060 L/h - Volume of distribution (Vd): approximately 200 L - Absorption fraction: increased 13.1% from day 1 to day 14 Despite the short plasma half-life, once-daily dosing produces sustained IGF-1 elevation lasting 12–24 hours. Comparatively, native GHRH has a plasma half-life of approximately 7 minutes, and sermorelin approximately 8–12 minutes. ## GH Pulsatility and IGF-1 Response A controlled study in healthy men (Stanley 2011 [10]) administered 2 mg/day subcutaneous tesamorelin for 2 weeks and measured overnight GH secretion: - Mean overnight GH significantly elevated (P=0.004) - GH pulse amplitude increased significantly; pulse frequency unchanged - IGF-1 raised by 181 µg/L (P<0.0001) - Insulin-stimulated glucose uptake did not change significantly ## Tesamorelin Dosage and Glucose Safety in Type 2 Diabetes A 12-week randomized placebo-controlled trial (Clemmons 2017 [11]) enrolled 53 patients with type 2 diabetes and administered tesamorelin at 1 mg/day or 2 mg/day: - Fasting glucose: no significant change at either dose - HbA1c: no significant change at either dose - Total cholesterol and non-HDL cholesterol: significantly decreased in the 2 mg group - Adverse events: mild; no serious events in either dose group ## Tesamorelin Reconstitution: Laboratory Handling Notes The FDA-approved Egrifta SV (2 mg/vial) formulation is reconstituted with the supplied sodium chloride diluent; the prescribing information specifies gentle swirling rather than shaking to avoid peptide degradation. [1] Tesamorelin reconstitution results in a clear, colorless solution. ## Tesamorelin Stability After Reconstitution The FDA-approved Egrifta SV label specifies use within 24 hours when stored at 2–8°C after reconstitution. [1] The intact lyophilized formulation should be stored at 2–8°C before reconstitution and protected from light. ## Duration of Administration in Published Trials - 12 weeks: Clemmons 2017 type 2 diabetes safety trial [11] - 20 weeks: Baker 2012 cognitive function trial [7] - 26 weeks: Falutz 2007 pivotal NEJM trial; Stanley 2014 liver-fat JAMA trial [1][5] - 6 months: Ellis 2025 HIV neurocognition trial [8] - 52 weeks: Falutz 2008 extension; Falutz 2010 safety extension [2][3] - 12 months: Stanley 2019 NAFLD trial; Fourman 2024 INSTI trial [6][17] All major trials used daily dosing. Discontinuation across all trials resulted in VAT reaccumulation within approximately 12 weeks. [2][3] ## References [1] Falutz J, et al. N Engl J Med. 2007;357(23):2359-70. https://pubmed.ncbi.nlm.nih.gov/18057338/ [2] Falutz J, et al. AIDS. 2008;22(14):1719-28. https://pubmed.ncbi.nlm.nih.gov/18690162/ [3] Falutz J, et al. J Acquir Immune Defic Syndr. 2010;53(3):311-22. https://pubmed.ncbi.nlm.nih.gov/20101189/ [5] Stanley TL, et al. JAMA. 2014;312(4):380-389. https://pubmed.ncbi.nlm.nih.gov/25038357/ [6] Stanley TL, et al. Lancet HIV. 2019;6(12):e821-e830. https://pubmed.ncbi.nlm.nih.gov/31611038/ [7] Baker LD, et al. Arch Neurol. 2012;69(11):1420-9. https://pubmed.ncbi.nlm.nih.gov/22869065/ [8] Ellis RJ, et al. J Infect Dis. 2025;231(5):1230-1238. https://pubmed.ncbi.nlm.nih.gov/39813152/ [9] González-Sales M, et al. Clin Pharmacokinet. 2015;54(3):285-94. https://pubmed.ncbi.nlm.nih.gov/25358450/ [10] Stanley TL, et al. J Clin Endocrinol Metab. 2011;96(1):150-158. https://pubmed.ncbi.nlm.nih.gov/20943777/ [11] Clemmons DR, et al. PLoS One. 2017;12(6). https://pubmed.ncbi.nlm.nih.gov/28617838/ [17] Fourman LT, et al. AIDS. 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC11365754/ --- A peer-reviewed field record of the tesamorelin literature — FDA approvals, Phase III trials, and pharmacokinetics indexed here, not prescribed here.