Skip to content
Trial protocolFat loss and metabolism

Tesamorelin 2 mg daily, the pivotal lipodystrophy schedule

Reduce visceral abdominal fat in HIV associated lipodystrophy

The schedule a registered trial actually ran, taken from the paper and the trial registration rather than from a label summary. Every one carries a PubMed or ClinicalTrials record you can open.

Not advice. This is a record of a schedule, not a dose for you.

The schedule, as reported

Each field below is what the source states, not a rounded version of it. Where the source does not publish a detail, the field says so instead of filling the gap.

Amount
2 mg
Frequency
Once daily
Route
Subcutaneous injection
Duration
26 weeks

What was measured

Percent change from baseline in visceral adipose tissue on computed tomography, primary. Triglycerides, the ratio of total cholesterol to HDL cholesterol, IGF-1 and self assessed body image were secondary, with glucose and insulin as glycaemic measures.

What was reported

Results as the trial reported them, with their comparators.

  • Visceral adipose tissue fell 15.2 percent on tesamorelin and rose 5.0 percent on placebo.

  • Triglycerides fell 50 mg per decilitre and rose 9 mg per decilitre respectively. The total cholesterol to HDL ratio fell 0.31 and rose 0.21.

  • IGF-1 rose 81.0 percent on tesamorelin and fell 5.0 percent on placebo.

  • No significant differences were seen in the glycaemic measures.

  • Adverse events did not differ significantly between groups, but more patients on tesamorelin withdrew because of one.

Where this comes from

Falutz et al., Metabolic effects of a growth hormone-releasing factor in patients with HIV, New England Journal of Medicine, 2007. 412 patients with HIV and abdominal fat accumulation, 86 percent of them men.

This is the trial the approval rests on, and the 2 mg daily schedule is the approved one. A separate 20 week trial in older adults used 1 mg daily for a cognitive endpoint, which is a different schedule for a different question and is not this protocol.

What this protocol cannot tell you

Required on every entry in this registry, and never empty.

The population was people with HIV whose abdominal fat accumulated on antiretroviral therapy, which is not the same as a person who wants a flatter stomach. The endpoint was a fat measurement on a CT scan, so nothing here was measured about heart attacks, diabetes or how long anyone lived. The trial ran 26 weeks and says nothing about what happens after that, or about what happens when the drug stops. IGF-1 rising 81 percent is a signal that the axis moved, not a benefit in itself.

The compounds in this protocol

Each profile carries the full evidence record, the legal status and what the trials did not show.

  • Tesamorelin

    An FDA-approved GHRH analogue that reduces visceral fat, now also studied for cognition in older adults at Alzheimer's risk.

Other trial protocols in the registry

All protocols