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Tesamorelin · Phase 3 · Completed

Tesamorelin phase 3 (Falutz, NEJM 2007)

In Tesamorelin phase 3 (Falutz, NEJM 2007), a phase 3 trial of tesamorelin in adults with HIV and abdominal fat accumulation (86% men) (n=412), the visceral adipose tissue was -15.2% on 2 mg over 26 weeks, against +5.0% on placebo (Falutz J et al. N Engl J Med 2007 (tesamorelin phase 3)).

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Results

Visceral adipose tissue
2 mg-15.2%
Placebo+5.0%

Triglycerides fell 50 mg per decilitre on tesamorelin and rose 9 mg per decilitre on placebo.

Side effects reported

Tesamorelin phase 3 (Falutz, NEJM 2007): The abstract reports that adverse events did not differ significantly between groups, but that more participants on tesamorelin withdrew because of an adverse event; it gives no rates.

Design

Trial design and sources

Compound
Tesamorelin
Phase
3
Population
Adults with HIV and abdominal fat accumulation (86% men)
Participants randomised
412
Duration
26 weeks
Primary endpoint
Percent change from baseline in visceral adipose tissue on computed tomography
Estimand
Not stated in the source read
Read out
1 December 2007

The abstract reports that adverse events did not differ significantly between groups, but that more participants on tesamorelin withdrew because of an adverse event; it gives no rates.

  • Falutz J et al. N Engl J Med 2007 (tesamorelin phase 3) open · checked 23 September 2026
  • ClinicalTrials.gov NCT00123253 open · checked 23 September 2026
  • Registry: NCT00123253

Questions

Tesamorelin phase 3 (Falutz, NEJM 2007), answered

What did Tesamorelin phase 3 (Falutz, NEJM 2007) find?

In Tesamorelin phase 3 (Falutz, NEJM 2007), a phase 3 trial of tesamorelin in adults with HIV and abdominal fat accumulation (86% men) (n=412), the visceral adipose tissue was -15.2% on 2 mg over 26 weeks, against +5.0% on placebo (Falutz J et al. N Engl J Med 2007 (tesamorelin phase 3)).

What side effects were reported in Tesamorelin phase 3 (Falutz, NEJM 2007)?

Tesamorelin phase 3 (Falutz, NEJM 2007): The abstract reports that adverse events did not differ significantly between groups, but that more participants on tesamorelin withdrew because of an adverse event; it gives no rates.