---
title: "Tesamorelin phase 3 (Falutz, NEJM 2007): Tesamorelin Phase 3"
url: https://www.primaralabs.com/research/trials/tesamorelin-phase-3-2007
source: Primara Labs, markdown mirror of the HTML page
---

# 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

*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](https://doi.org/10.1056/NEJMoa072375) · checked 23 September 2026
-   ClinicalTrials.gov NCT00123253 [open](https://clinicaltrials.gov/study/NCT00123253) · 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.

Related

## More on tesamorelin

-   [Evidence Map: Tesamorelin](https://www.primaralabs.com/research/evidence#tesamorelin)
-   [Tesamorelin 10mg](https://www.primaralabs.com/marketplace/tesamorelin-10mg)