18+ · Research use only
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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Updated 24 September 2026
Results
| 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.
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.