Data edition of
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Tesamorelin dosage in clinical trials

What dose levels researchers actually tested, quoted from the trial registry and the published reports — so the numbers circulating online can be checked against their source.

Doses in published trials

Table 1. Dose arms of the principal published Tesamorelin trials, as reported in the cited paper.
TrialPopulationDose armsScheduleRef.
Phase 3 pooled (two trials)HIV with excess abdominal fat2 mgDaily SC, 26 weeks + 26-week extension1
Liver-fat RCTHIV with abdominal fat accumulation; n=48 treated2 mgDaily SC, 6 months2
Figure 1. Dose levels named in ClinicalTrials.gov arm descriptions that mention Tesamorelin, counted once per study (11 interventional studies). Includes titration steps and single-dose pharmacology studies; a level appearing often is not evidence that it is effective or safe.

Arms as registered

Verbatim arm text from ClinicalTrials.gov. Only arms naming Tesamorelin and a dose are shown.

  1. NCT00608023 · Phase 3 · Completed · n=263

    TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

    • Tesamorelin 12 months (T-T) — Tesamorelin 2 mg/day for 12 months
    • Tesamorelin-Placebo (T-P) — Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
    • Placebo-Tesamorelin (P-T) — Placebo 6 months - Tesamorelin 2 mg/day for 6 months

  2. NCT03226821 · Phase 4 · Terminated · n=6

    Body Composition and Adipose Tissue in HIV

    • Tesamorelin — Subjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit.

  3. NCT07481734 · Phase 2 · Recruiting · n=120

    Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)

    • Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I

  4. NCT06554717 · Phase 2 · Recruiting · n=100

    Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

    • Tesamorelin Plus Exercise — Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention

  5. NCT03375788 · Phase 2 · Completed · n=51

    Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk

    • Tesamorelin — tesamorelin (brand name Egrifta) 2mg daily given subcutaneously

  6. NCT02572323 · Phase 2 · Completed · n=73

    Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

    • Immediate group — 1.4mg of tesamorelin is injected once a day for 6 months, then no treatment is given for 6 months
    • Deferred group — No treatment is given for 6 months, then 1.4mg of tesamorelin is injected once a day for 6 months

  7. NCT01388920 · Phase 2 · Terminated · n=3

    Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting

    • Tesamorelin 2 mg — Tesamorelin 2 mg/day
    • Tesamorelin 3 mg — Tesamorelin 3 mg/day

  8. NCT02196831 · N/A · Completed · n=61

    Tesamorelin Effects on Liver Fat and Histology in HIV

    • Tesamorelin — tesamorelin 2mg subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.

  9. NCT01263717 · N/A · Completed · n=54

    Effects of Growth Hormone Releasing Hormone in HIV

    • Tesamorelin — Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
    • Placebo (inactive injection) — Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase

  10. NCT00850564 · N/A · Completed · n=15

    Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

    • Growth Hormone Releasing Hormone — Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

  11. NCT00795210 · N/A · Completed · n=25

    Effects of Short-term Growth Hormone in HIV-infected Patients

    • Growth Hormone Releasing Hormone — Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

  1. 1 PubMed Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab 2010. PMID 20554713; doi:10.1210/jc.2010-0490.
  2. 2 PubMed Stanley TL, Feldpausch MN, Oh J, et al. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA 2014. PMID 25038357; doi:10.1001/jama.2014.8334.

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