T-02
Study dose explorer
Every dose reported in the published literature for this compound, filterable by species and route, each row sourced.
Every dose you see quoted for tesamorelin traces to a study, and the studies disagree less than the marketing does: the approved regimen used 2 mg daily (now delivered as 1.4 mg SV or 1.28 mg WR at equivalent exposure), the cognition trial used 1 mg, and the phase 2 trial tested both. This explorer puts every human study dose in one sortable table with its population, duration, and measured outcome, so a quoted number can be checked against what was actually studied.
Published records (10 of 10)
| Population | Dose and route | Duration | Primary outcome result | Source |
|---|---|---|---|---|
| HIV lipodystrophy, phase 3 Study 1 (n=412) | 2 mg SC daily | 26 weeks | VAT -15.2% vs +5.0% placebo (CT) | Falutz 2007 |
| HIV lipodystrophy, phase 3 Study 2 (n=404) | 2 mg SC daily | 26 weeks + extension | VAT -10.9% vs -0.6%; regain on switch to placebo | Falutz 2010 JAIDS |
| HIV lipodystrophy, pooled phase 3 (n=806) | 2 mg SC daily | 26 to 52 weeks | VAT -15.4% treatment effect; -17.5% maintained at week 52 on drug | Falutz 2010 JCEM |
| HIV lipodystrophy, Study 1 extension (n=410) | 2 mg SC daily vs stop | 52 weeks | VAT sustained -18% on drug; reaccumulated after discontinuation | Falutz 2008 |
| HIV lipodystrophy, phase 2 (n=61) | 1 or 2 mg SC daily | 12 weeks | IGF-1 +48%/+65%; trunk fat -9.2% at 2 mg | Falutz 2005 |
| HIV, visceral and liver fat (n=50) | 2 mg SC daily | 6 months | VAT -42 cm2 treatment effect; liver fat -2.9% net | Stanley 2014 |
| Non-HIV abdominal obesity, reduced GH (n=60) | 2 mg SC daily | 12 months | VAT -35 cm2 treatment effect; no weight change reported as outcome | Makimura 2012 |
| HIV with NAFLD (n=61) | 2 mg SC daily | 12 months | Liver fat -37% relative; 35% vs 4% reached HFF under 5% | Stanley 2019 |
| Older adults with and without MCI (n=152) | 1 mg SC daily, bedtime | 20 weeks | Cognitive composite improved (executive P=.005); IGF-1 +117% | Baker 2012 |
| Current approved regimens | 1.4 mg (SV) or 1.28 mg (WR) SC daily | ongoing use per label | Exposure-matched to the studied 2 mg dose | SV/WR labels |
Every row restates a published record; sources resolve on the sourced monograph. Species is part of the data: this table never scales an animal dose into a human figure.
Worked example
How to read a claim against this table: a clinic quoting 'tesamorelin 2 mg for belly fat' is quoting the dose from the HIV-lipodystrophy phase 3 program (rows 1 to 4), where VAT fell 15.2% and 10.9% versus placebo at 26 weeks. The only non-HIV randomized trial (row 7) used the same 2 mg for 12 months in obese adults with reduced GH secretion and reduced VAT by about 35 cm2 versus placebo, with no approval following. No study at any dose showed meaningful weight loss: the label calls the effect weight neutral.
Step by step
- Find the population that matches the claim you are checking: HIV lipodystrophy (approved), non-HIV obesity, NAFLD, or older adults (cognition).
- Read the dose and duration columns together: the phase 3 effect took 26 weeks at 2 mg, and the extensions show it unwinding on stopping.
- Check the outcome column for what was actually measured: CT-measured VAT, liver fat fraction, or cognitive composites, never bathroom-scale weight.
- Open the source link on any row before repeating its number.
Every human tesamorelin study dose in this pack (education, not recommendations)
| # | Population | Dose and route | Duration | Primary outcome result | Source | Source |
|---|---|---|---|---|---|---|
| 1 | HIV lipodystrophy, phase 3 Study 1 (n=412) | 2 mg SC daily | 26 weeks | VAT -15.2% vs +5.0% placebo (CT) | Falutz 2007 | source |
| 2 | HIV lipodystrophy, phase 3 Study 2 (n=404) | 2 mg SC daily | 26 weeks + extension | VAT -10.9% vs -0.6%; regain on switch to placebo | Falutz 2010 JAIDS | source |
| 3 | HIV lipodystrophy, pooled phase 3 (n=806) | 2 mg SC daily | 26 to 52 weeks | VAT -15.4% treatment effect; -17.5% maintained at week 52 on drug | Falutz 2010 JCEM | source |
| 4 | HIV lipodystrophy, Study 1 extension (n=410) | 2 mg SC daily vs stop | 52 weeks | VAT sustained -18% on drug; reaccumulated after discontinuation | Falutz 2008 | source |
| 5 | HIV lipodystrophy, phase 2 (n=61) | 1 or 2 mg SC daily | 12 weeks | IGF-1 +48%/+65%; trunk fat -9.2% at 2 mg | Falutz 2005 | source |
| 6 | HIV, visceral and liver fat (n=50) | 2 mg SC daily | 6 months | VAT -42 cm2 treatment effect; liver fat -2.9% net | Stanley 2014 | source |
| 7 | Non-HIV abdominal obesity, reduced GH (n=60) | 2 mg SC daily | 12 months | VAT -35 cm2 treatment effect; no weight change reported as outcome | Makimura 2012 | source |
| 8 | HIV with NAFLD (n=61) | 2 mg SC daily | 12 months | Liver fat -37% relative; 35% vs 4% reached HFF under 5% | Stanley 2019 | source |
| 9 | Older adults with and without MCI (n=152) | 1 mg SC daily, bedtime | 20 weeks | Cognitive composite improved (executive P=.005); IGF-1 +117% | Baker 2012 | source |
| 10 | Current approved regimens | 1.4 mg (SV) or 1.28 mg (WR) SC daily | ongoing use per label | Exposure-matched to the studied 2 mg dose | SV/WR labels | source |
Frequently asked questions
Is a higher tesamorelin dose better?
The evidence says the studied dose is the studied dose: phase 2 found 2 mg beat 1 mg on trunk fat and IGF-1, the entire phase 3 program then used 2 mg, and no trial has tested more. The label's monitoring thresholds were calibrated at that exposure; exceeding it is unstudied territory.
The dose-response evidence begins and ends in the phase 2 trial: 2 mg produced a larger IGF-1 rise (+65% vs +48%) and a significant trunk-fat reduction where 1 mg did not, so 2 mg became the phase 3 and label dose. No published randomized trial has tested a higher dose in any population, which means nobody has measured what more would do to efficacy, to IGF-1 elevations (already above 3 SDS in 36% of patients at the studied dose), or to glucose.
Note also that the current products deliver the studied exposure at lower nominal doses (1.4 mg SV, 1.28 mg WR are exposure-matched to the original 2 mg), so comparing milligram numbers across formulations misleads. More is not a documented option; it is an undocumented experiment.
How long did it take to see effects in the studies?
The phase 3 primary endpoint was measured at 26 weeks; IGF-1 elevations appeared by week 13; the liver trial ran 12 months; cognition, 20 weeks. Nothing in the record supports judging visceral fat in a few weeks, and the same trials show the effect unwinding within 26 weeks of stopping.
The trial clocks are the honest expectation-setters. The pivotal trials measured visceral fat at 26 weeks; that is the timescale on which the -15.2% and -10.9% results exist, and the label's efficacy re-evaluation language (reconsider treatment in patients without a VAT reduction) presumes that kind of horizon. The lab response runs faster: IGF-1 elevations appeared by week 13, which is why early monitoring matters. The NAFLD result took 12 months; the cognition composite, 20 weeks.
The same program timed the decay: within 26 weeks of a blinded switch to placebo, VAT was back up 22% and 16% and IGF-1 had fallen to near baseline. Expect months to see the effect, and expect months for it to unwind.
Do the trial results apply to someone without HIV?
Mostly unknown. One randomized non-HIV trial exists: 60 obese adults with reduced GH secretion, 12 months, VAT down about 35 cm2 vs placebo, glucose unchanged. That is the entire general-population record. The approval, and most of the safety data, live in HIV lipodystrophy.
The honest answer is one trial deep. Makimura 2012 randomized 60 abdominally obese adults with reduced GH secretion (no HIV) to tesamorelin 2 mg or placebo for 12 months: VAT fell (treatment effect -35 cm2), triglycerides, CRP, and carotid intima-media thickness improved, subcutaneous fat did not change, and glucose was untouched. Encouraging, small, never replicated, and never submitted as an approval.
Everything else, the phase 3 efficacy, the extension regain data, the adverse-event rates, the liver results, was measured in people with HIV, most on antiretroviral therapy, whose baseline physiology (including the 34% higher drug exposure the label notes) differs from the general population. Extrapolating the full benefit-risk picture from that record to a healthy 45-year-old is exactly the leap the label never makes, which is why the general-population question in our limits section stays open.
Tools: educational calculators and references only.