Trial abstract · §3
TESA-PIVOTAL-1 — results
Primary endpoint, absolute and relative effect where derivable, and harms as reported.
§3Results
§3.1Primary endpoint
Table 3. Primary endpoint as reported.
| Endpoint | Result as reported | Certainty |
|---|---|---|
| Percentage change in visceral adipose tissue measured by computed tomography at week 26 | Mean change −15.2 % versus −5.0 % with placebo | Moderate |
| Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed. | ||
§3.2Endpoint hierarchy
§3.3Harms as reported
Table 5. Adverse events for Tesamorelin from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.
| Event | Active, % | Comparator, % | Source trial |
|---|---|---|---|
| Injection-site erythema | 25.0 | 5.0 | Pivotal pooled |
| Arthralgia | 13.0 | 9.0 | Pivotal pooled |
| Peripheral oedema | 6.0 | 2.0 | Pivotal pooled |
| Myalgia | 5.0 | 2.0 | Pivotal pooled |
| Paraesthesia | 5.0 | 1.0 | Pivotal pooled |
| Glucose intolerance / raised HbA1c | — | — | A recognised class effect of growth-hormone-axis stimulation; monitoring advised |
| IGF-1 above the reference range | 34.0 | — | Pivotal pooled |
| Hypersensitivity reaction | — | — | Reported at low incidence |
Compound Evidence Institute · CEI-TR-0097/3 · https://compoundevidence.com/trials/tesa-pivotal-1/results/ · retrieved 30 July 2026