Also identified as TH9507, trans-3-hexenoyl GHRH (1-44) amide
Growth-hormone-releasing hormone analogue
Molecular weight
5136
Molecular formula
C221H366N72O67S
CAS
218949-48-5
Published studies reviewed
3
FOR RESEARCH USE ONLY. NOT FOR HUMAN OR VETERINARY USE. NOT FOR HUMAN CONSUMPTION.
Compounds described on this site are supplied solely for laboratory research. They are not offered for human or veterinary use or for clinical use, and they are not intended to diagnose, mitigate, cure or prevent any disease.
Tesamorelin is a stabilised analogue of growth-hormone-releasing hormone: GHRH(1-44) carrying a trans-3-hexenoyl group that slows its breakdown. Three human publications are reviewed: pooled phase 3 studies, a further randomised study, and a randomised study in a different population that found no difference from placebo. The U.S. FDA has approved a drug product containing tesamorelin, and the PepGenex research material is neither that product nor the material these trials used.
An FDA approved drug product containing tesamorelin exists. Source: Drugs@FDA, Application BLA 022505.
Overview
Tesamorelin is a stabilised analogue of growth-hormone-releasing hormone — GHRH (1-44) with a trans-3-hexenoyl group attached, which slows its breakdown.
The human literature on it is unusually well developed for a compound of this kind, and it is unusually specific. Almost all of it was recorded in one population: adults with HIV, on antiretroviral therapy, with excess abdominal fat. Two pooled phase 3 studies of 806 participants measured visceral adipose tissue; a later randomised study of 50 participants measured visceral adipose tissue and liver fat together; a third randomised study, in 53 adults with type 2 diabetes, measured insulin response and glycaemic control and found no difference from placebo.
All three are on this page, including the one that found nothing.
Regulatory status
An FDA approved drug product containing tesamorelin exists. PepGenex research materials are not that product, are not FDA approved, and are not for human or veterinary use.
Source: Drugs@FDA, Application BLA 022505. Verified 2026-09-24.
Mechanism under investigation
Tesamorelin
Agonist
→
Growth-hormone-releasing hormone receptor
Described in the publications as a growth-hormone-releasing factor analogue. The pooled phase 3 analysis recorded a rise in IGF-I alongside the changes in adipose tissue it measured.
Scope of the published work
Areas investigated
Visceral adipose tissue
Liver fat content
Lipid measures
Glycaemic control and insulin response
Models used
Randomised human studies
Pooled phase 3 analysis
Nearly every figure on this page was recorded in adults with HIV on antiretroviral therapy, under a controlled protocol, using material prepared for that study. The one study conducted in a different population — adults with type 2 diabetes — found no change in its primary measure. Nothing here is a statement about the research material PepGenex supplies.
Limitations
Evidence represented on this page: human. No in vitro or animal research is represented. The page reviews 3 published studies, and each figure is reported for the study that published it; results are not pooled across studies.
Common questions
What is Tesamorelin?
Tesamorelin is a stabilised analogue of growth-hormone-releasing hormone — GHRH (1-44) with a trans-3-hexenoyl group attached, which slows its breakdown.
How does Tesamorelin work, according to the published research?
Described in the publications as a growth-hormone-releasing factor analogue. The pooled phase 3 analysis recorded a rise in IGF-I alongside the changes in adipose tissue it measured.
What has published research on Tesamorelin found, and what are its limits?
This page records 3 publications, reporting human work in 3. Each is listed with its identifier under References.
Human studies represented: Clemmons et al., 2017, PMID 28617838; Stanley et al., 2014, PMID 25038357; Falutz et al., 2010, PMID 20554713.
Evidence represented on this page: human.
No in vitro or animal research is represented.
The page reviews 3 published studies, and each figure is reported for the study that published it; results are not pooled across studies.
Nearly every figure on this page was recorded in adults with HIV on antiretroviral therapy, under a controlled protocol, using material prepared for that study. The one study conducted in a different population — adults with type 2 diabetes — found no change in its primary measure. Nothing here is a statement about the research material PepGenex supplies.
Is Tesamorelin approved by the U.S. FDA?
An FDA approved drug product containing tesamorelin exists. PepGenex research materials are not that product, are not FDA approved, and are not for human or veterinary use.
Source: Drugs@FDA, Application BLA 022505. Verified 2026-09-24.
What risks have published studies of Tesamorelin reported?
3 published human studies on this page report adverse events or safety measurements. Each is listed with its publication in the adverse-events section of this page.
Trial events do not establish a complete safety profile.
What adverse events have been reported in published studies of Tesamorelin?
Adverse events and safety measurements as reported by the published human studies on this page. Each entry is attributed to its publication.
Clemmons et al., 2017, PMID 28617838
Design and population
A 12-week randomised, placebo-controlled study in 53 adults with type 2 diabetes, with three arms: placebo and two tesamorelin arms. The stated main outcome measure was the relative insulin response following oral glucose.
Events reported
In the higher-dose tesamorelin arm, total cholesterol fell by 0.3 ± 0.6 mmol/L and non-HDL cholesterol by 0.3 ± 0.5 mmol/L from baseline to week 12, each reported at p < 0.05 against placebo. Nobody left the study because of loss of diabetes control.
Stanley et al., 2014, PMID 25038357
Design and population
Double-blind, randomised, placebo-controlled study at one hospital. 50 adults with HIV on antiretroviral therapy and abdominal fat accumulation were randomised to tesamorelin (n = 28) or placebo (n = 22) for 6 months; 48 went on to receive study material. The co-primary endpoints were change in visceral adipose tissue and change in liver fat.
Events reported
Fasting glucose rose in the tesamorelin arm at 2 weeks: mean change 9 mg/dL (95% CI 5 to 13) against 2 mg/dL (95% CI -3 to 8) in the placebo arm, a difference of 7 mg/dL (95% CI 1 to 14), with P = .03. That early rise did not persist. At 6 months the change in fasting glucose was 4 mg/dL (95% CI -2 to 10) against 2 mg/dL (95% CI -4 to 7) in the placebo arm — a difference of 2 mg/dL (95% CI -6 to 10), P = .72 across time points — and the difference in 2-hour glucose was 7 mg/dL (95% CI -16 to 29), P = .53. Neither was significant.
Falutz et al., 2010, PMID 20554713
Design and population
Pooled analysis of two multicentre, double-blind, placebo-controlled phase 3 studies. 806 adults with HIV on antiretroviral therapy and excess abdominal fat were randomised 2:1 to tesamorelin (n = 543) or placebo (n = 263) for a 26-week randomised phase, followed by a 26-week extension in which those initially on tesamorelin were re-randomised to continue it (n = 246) or to placebo (n = 135), and those on placebo were switched to tesamorelin (n = 197).
Events reported
The publication reports no clinically meaningful differences between the groups in glucose measures at week 26 or at week 52, and describes the compound as generally well tolerated.
Trial events do not establish a complete safety profile.
Published research
Grouped by the kind of study. Select one to narrow what is shown below.
Human study (phase not stated)(2)
Human study (phase not stated)n = 53
Clemmons et al., 2017 (title withheld on this site; see the publication record)
Clemmons DR, Miller S, Mamputu JC, PLOS ONE, 2017;12(6):e0179538
published
A 12-week randomised, placebo-controlled study in 53 adults with type 2 diabetes, with three arms: placebo and two tesamorelin arms. The stated main outcome measure was the relative insulin response following oral glucose.
No significant differences were observed between the groups in relative insulin response over the 12-week period. At week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups, and changes to diabetes medicines were similar across them.
In the higher-dose tesamorelin arm, total cholesterol fell by 0.3 ± 0.6 mmol/L and non-HDL cholesterol by 0.3 ± 0.5 mmol/L from baseline to week 12, each reported at p < 0.05 against placebo. Nobody left the study because of loss of diabetes control.
Context
This is the study that found nothing, and it is the most useful one on the page for reading the other two. It was run in a different population — adults with type 2 diabetes rather than adults with HIV — and on its primary measure it reported no difference from placebo. A compound's published record is the whole set of studies, including the ones whose result was no result.
Stanley et al., 2014 (title withheld on this site; see the publication record)
Stanley TL, Feldpausch MN, Oh J, et al., JAMA, 2014;312(4):380-389
published
Double-blind, randomised, placebo-controlled study at one hospital. 50 adults with HIV on antiretroviral therapy and abdominal fat accumulation were randomised to tesamorelin (n = 28) or placebo (n = 22) for 6 months; 48 went on to receive study material. The co-primary endpoints were change in visceral adipose tissue and change in liver fat.
Visceral adipose tissue, mean change from baseline (co-primary endpoint)
Randomised, controlled · Month 6 · Adults with HIV on antiretroviral therapy and excess abdominal fat
Arm
Reported
Tesamorelin
-34 cm² (95% CI -53 to -15)
Placebo
+8 cm² (95% CI -14 to 30)
Liver fat, median change in lipid-to-water percentage (co-primary endpoint)
Randomised, controlled · Month 6 · Adults with HIV on antiretroviral therapy and excess abdominal fat
Arm
Reported
Tesamorelin
-2.0% (IQR -6.4 to 0.1)
Placebo
+0.9% (IQR -0.6 to 3.7)
The difference between the arms in visceral adipose tissue at 6 months was -42 cm² (95% CI -71 to -14), with P = .005.
The net difference between the arms in the liver lipid-to-water percentage at 6 months was -2.9%, with P = .003.
Fasting glucose rose in the tesamorelin arm at 2 weeks: mean change 9 mg/dL (95% CI 5 to 13) against 2 mg/dL (95% CI -3 to 8) in the placebo arm, a difference of 7 mg/dL (95% CI 1 to 14), with P = .03.
That early rise did not persist. At 6 months the change in fasting glucose was 4 mg/dL (95% CI -2 to 10) against 2 mg/dL (95% CI -4 to 7) in the placebo arm — a difference of 2 mg/dL (95% CI -6 to 10), P = .72 across time points — and the difference in 2-hour glucose was 7 mg/dL (95% CI -16 to 29), P = .53. Neither was significant.
What this study establishes
This study measured two things at once, in 50 participants, and both co-primary endpoints moved: visceral adipose tissue and the lipid-to-water percentage in the liver. The glucose finding is shown as two entries because it was two findings — a rise at two weeks that was statistically significant, and no significant difference at six months.
Falutz et al., 2010 (title withheld on this site; see the publication record)
Falutz J, Mamputu JC, Potvin D, et al., The Journal of Clinical Endocrinology and Metabolism, 2010;95(9):4291-4304
published
Pooled analysis of two multicentre, double-blind, placebo-controlled phase 3 studies. 806 adults with HIV on antiretroviral therapy and excess abdominal fat were randomised 2:1 to tesamorelin (n = 543) or placebo (n = 263) for a 26-week randomised phase, followed by a 26-week extension in which those initially on tesamorelin were re-randomised to continue it (n = 246) or to placebo (n = 135), and those on placebo were switched to tesamorelin (n = 197).
Visceral adipose tissue, change from baseline
Randomised, controlled · Week 26 · Adults with HIV on antiretroviral therapy and excess abdominal fat
Arm
Reported
Tesamorelin
-24 ± 41 cm²
Placebo
+2 ± 35 cm²
Abdominal subcutaneous adipose tissue, change from baseline
Randomised, controlled · Week 26 · Adults with HIV on antiretroviral therapy and excess abdominal fat
Arm
Reported
Tesamorelin
-2 ± 32 cm²
Placebo
+2 ± 29 cm²
Triglycerides, change from baseline
Randomised, controlled · Week 26 · Adults with HIV on antiretroviral therapy and excess abdominal fat
Arm
Reported
Tesamorelin
-37 ± 139 mg/dl
Placebo
+6 ± 112 mg/dl
IGF-I, change from baseline
Randomised, controlled · Week 26 · Adults with HIV on antiretroviral therapy and excess abdominal fat
Arm
Reported
Tesamorelin
+108 ± 112 ng/ml
Placebo
-7 ± 64 ng/ml
Visceral adipose tissue, change from original baseline
The difference between the arms in visceral adipose tissue at week 26 was reported as -15.4%, with P < 0.001.
The publication reports no clinically meaningful differences between the groups in glucose measures at week 26 or at week 52, and describes the compound as generally well tolerated.
What this study establishes
Across 806 participants in two phase 3 studies, visceral adipose tissue fell in the tesamorelin arm and did not fall in the placebo arm, measured by computed tomography at week 26. Abdominal subcutaneous adipose tissue did not change significantly in either arm, which is what makes the visceral figure specific rather than a general change in abdominal fat.
Limitations
The week 52 figures are not a longer version of the week 26 figures. They describe only the participants who were re-randomised to continue, which is a selected group by construction, and they are measured against the original baseline rather than against a placebo arm. That is why they sit in their own table.
Classification, structure, recorded targets, evidence types and FDA status only, each read from the two compounds' own pages. These comparisons do not compare study results.
Sequence Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-NH2; formula C149H246N44O42S
An FDA approved drug product containing tesamorelin exists. Source: Drugs@FDA, Application BLA 022505.
Drugs@FDA lists two approved applications for sermorelin acetate, and the products under both are listed as discontinued. Source: Drugs@FDA, Applications NDA 019863 and NDA 020443.
An FDA approved drug product containing tesamorelin exists. Source: Drugs@FDA, Application BLA 022505.
Not shown (no Drugs@FDA application record verified for this page)
References
Published studies reviewed (3)
Falutz et al., 2010 (title withheld on this site; see the publication record) — Falutz J, Mamputu JC, Potvin D, et al., The Journal of Clinical Endocrinology and Metabolism, 2010;95(9):4291-4304
