Two Phase 3 trials, extension data, current FDA labels, and additional condition-specific human studies.
Why this matters
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Growth hormone–releasing hormone (GHRH) analog
Tesamorelin is a GHRH analog with an FDA-approved role in reducing excess abdominal fat in adults with HIV and lipodystrophy. It has controlled human evidence for that specific outcome, but it is weight neutral and is not approved as a general weight-loss drug.
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Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Two Phase 3 trials, extension data, current FDA labels, and additional condition-specific human studies.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Visceral-fat reduction is well supported in adults with HIV-associated lipodystrophy; evidence outside that population is much narrower.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: The historical 2 mg formulation, EGRIFTA SV, and EGRIFTA WR have different strengths and preparation requirements and are not interchangeable. The short plasma half-life does not describe the duration of downstream GH/IGF-1 effects. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Common goals and questions—not recommendations or promises of benefit.
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
What the evidence says
Two randomized Phase 3 trials enrolling 816 adults with HIV-associated abdominal fat accumulation found meaningful reductions in CT-measured visceral fat over 26 weeks, with effects maintained during continued treatment in extension data.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Long-term cardiovascular safety, multi-year durability after discontinuation, and whether meaningful benefits extend beyond the narrow HIV-associated populations actually studied.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
The trial did not find a statistically significant between-group improvement in the primary neurocognitive outcome. Waist circumference decreased more in the tesamorelin group.
Among the 31 subgroup participants who completed 12 months, median VAT changed by −25 cm² with tesamorelin versus +14 cm² with placebo, and liver fat changed by −4.2 versus −0.5 percentage points.
Tesamorelin reduced hepatic fat fraction versus placebo, with an absolute treatment effect of −4.1 percentage points. Thirty-five percent of tesamorelin participants versus 4% of placebo participants reached liver fat below 5%.
Across the two trials, tesamorelin reduced visceral abdominal fat while body weight changed little. The FDA label reports mean VAT changes of −18% versus +2% in Study 1 and −14% versus −2% in Study 2 at 26 weeks.
The visceral-fat reduction was sustained at about 18% among participants who continued treatment for 52 weeks. The effect was lost after participants switched from tesamorelin to placebo.
Administration and handling
Current U.S. labels describe once-daily subcutaneous abdominal administration, but EGRIFTA WR and EGRIFTA SV have different strengths, labeled doses, volumes, diluents, and mixing procedures. EGRIFTA WR is labeled at 1.28 mg (0.16 mL) daily after weekly reconstitution; EGRIFTA SV is labeled at 1.4 mg (0.35 mL) immediately after single-vial reconstitution. These are official product descriptions—not personalized directions.
The March 2025 WR label says to mix one 11.6 mg vial with 1.3 mL of its supplied bacteriostatic water, swirl rather than shake, keep the mixed vial at 20–25°C, and discard it after seven days. The February 2024 SV label says to mix one 2 mg vial with 0.5 mL of its supplied sterile water, roll gently rather than shake, use it immediately, and discard unused solution and diluent. These instructions apply only to the named FDA-approved presentations—not generic or vendor-supplied vials.
Primary-source ledger
2025-03-01
2025-01-15 · PMID 39813152 · NCT02572323 · DOI 10.1093/infdis/jiaf012
2024-10-01 · PMID 38905488 · NCT02196831 · DOI 10.1097/QAD.0000000000003965
2024-02-01
2019-10-11 · PMID 31611038 · NCT02196831 · DOI 10.1016/S2352-3018(19)30338-8
2010-09-01 · PMID 20554713 · NCT00123253; NCT00435136 · DOI 10.1210/jc.2010-0490
2008-09-12 · PMID 18690162 · NCT00123253 · DOI 10.1097/QAD.0b013e32830a5058