Study 1
NCT00123253 · 412 randomized
Tesamorelin
−18%
Placebo
+2%
Page last checked
Abdominal fat · FDA-label results
Tesamorelin results at 26 and 52 weeks
At 26 weeks, visceral abdominal fat changed by −18% and −14% in the two tesamorelin groups, versus +2% and −2% with placebo. These are group averages in adults with HIV and lipodystrophy—not a personal timeline and not general weight loss.
Source: the current Egrifta SV label’s two pivotal studies
Read these tesamorelin results correctly
- What changed
- First main result
- Follow-up result
- Approved for weight loss
The first study result
What changed at 26 weeks
Both placebo-controlled studies used CT scans at the same abdominal level. The percentages below describe visceral adipose tissue, or VAT—the fat around internal organs—not total body weight and not the share of people who responded.
Study 2
NCT00435136 · 404 randomized
Tesamorelin
−14%
Placebo
−2%
| Measure | Study 1 · tesamorelin | Study 1 · placebo | Study 2 · tesamorelin | Study 2 · placebo |
|---|---|---|---|---|
| Visceral abdominal fat | −18% | +2% | −14% | −2% |
| Body weight (kg) | −0.4 | 0.0 | +0.5 | +0.3 |
| Trunk fat (kg) | −1.0 | +0.4 | −0.8 | +0.2 |
| Lean body mass (kg) | +1.3 | −0.2 | +1.2 | −0.03 |
Continue or switch · extension phase
What happened from week 26 to week 52
People who finished 26 weeks on tesamorelin were split at random again. Some continued; others switched to placebo. Every percentage in this section starts at week 26. It is not the total change from the start of the study.
Study 1
NCT00123253Continued tesamorelin
0%
Switched to placebo
+22%
Study 2
NCT00435136Continued tesamorelin
−5%
Switched to placebo
+16%
How to read the result
Tesamorelin is not a weight-loss drug
What the label supports
What it does not support
The questions people actually ask
When do tesamorelin results start?
How long does tesamorelin take to work?
The label does not set an onset week. It reports its first main result at week 26. That visit does not prove that nothing changed earlier. It also does not promise that one person will notice a change by then.
Did the trials measure belly fat or body weight?
Their main result was visceral abdominal fat measured by CT. Body weight barely changed in either direction. The label therefore says tesamorelin is not approved for weight-loss management.
What happened after people stopped?
The follow-up switched some 26-week completers to placebo. VAT increased from the week-26 value in both switched groups. The study did not test a taper. It also did not follow every original participant through a separate stopping plan.
Do these results come from the current Egrifta SV and WR doses?
The main studies used the older 2 mg Egrifta formula. The current labels connect those results to Egrifta SV and WR using blood-level studies. The two current products have different doses and cannot be swapped for each other.
Where to read next
- Tesamorelin dosage and product differences keeps the approved use and how it works together while separating Egrifta SV from WR.
- Tesamorelin side effects keeps trial reactions and label warnings separate from results.
- Tesamorelin versus sermorelin compares the current labeled product with a withdrawn one.
- EGRIFTA SV (tesamorelin) — FDA-approved Prescribing Information, Clinical Studies section (DailyMed)retrieved 2026-08-17FDA label
- EGRIFTA WR (tesamorelin) — FDA-approved Prescribing Information (DailyMed)retrieved 2026-08-17FDA label
- Tesamorelin Study 1 registry record — ClinicalTrials.gov NCT00123253retrieved 2026-08-17Human trial
- Tesamorelin Study 2 registry record — ClinicalTrials.gov NCT00435136retrieved 2026-08-17Human trial