| Dimension | Scoring Notes | Score |
|---|---|---|
| Study Design | Multiple Phase III RCTs specifically in HIV-associated lipodystrophy. FDA approved (Egrifta). Trials include LIPO-010 and LIPO-011 as pivotal studies, plus extension and follow-up trials. |
25 / 25 |
| Sample Size | Pivotal trials enrolled 400-600 participants each — solid for a specialized indication. Not thousands, but well-powered for the patient population. |
20 / 20 |
| Replication | Multiple independent Phase III trials plus academic replication. Results consistently replicated across different investigator groups and countries. |
15 / 20 |
| Journal Impact Factor | Primary publications in Journal of Clinical Endocrinology & Metabolism (IF ~6.5) and AIDS (IF ~4.5). High-quality specialty journals. |
12 / 15 |
| Funding Independence | Theratechnologies (manufacturer) funded pivotal trials. Pre-registered, FDA-reviewed, but industry funded. Some independent academic follow-up studies exist. |
10 / 10 |
| Population Diversity | HIV lipodystrophy population is inherently diverse by nature of the epidemic. Studies enrolled diverse age, sex, and ethnic groups. |
4 / 5 |
| Researcher h-Index | Steven Grinspoon (Harvard/MGH), lead tesamorelin researcher, h-Index above 60 with extensive HIV/metabolic research portfolio. |
2 / 5 |