Now reading Entry 089 / 102 Last revised Sep 28, 2026 35 sources 2 comparisons Methodology →
A specimen of the Hormonal drawer Drawer C · Hormonal

Tesamorelin

FDA Approved

Tesamorelin is a GHRH analog approved in the United States as EGRIFTA WR and EGRIFTA SV to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. The strongest clinical evidence concerns CT-measured visceral adipose tissue (VAT) in that population; liver and cognitive outcomes have narrower or inconclusive evidence.

Egrifta · Egrifta SV · Egrifta WR · TH9507

Research evidence
High

High evidence applies to VAT reduction in adults with HIV-associated lipodystrophy; it does not grade liver disease, cognition, anti-aging, or general weight loss as established uses.

Preclinical
0%
Human research
37%

Based on 35 cited sources

Thirty-five distinct cited records comprise 13 human publications, 20 official ClinicalTrials.gov records, and two regulatory label records. The human publications comprise eight trial reports, one pooled analysis of two pivotal trials, three secondary analyses of the HIV fatty-liver trial, and one tesamorelin-specific meta-analysis. Overlapping participants are not counted as separate trials. The FDA label and ClinicalTrials.gov records are additional regulatory and registry records, not publications. Six publication full texts were confirmed free in PMC; openAccess is a conservative verified minimum, not an exhaustive availability assessment. The legacy 52/35/4/42 totals could not be reproduced from the existing source pack and were withdrawn.

Evidence score pending review

Historical numeric scores and community claims depend on an unverified 52-source denominator, overlapping pivotal publications, indirect GH-axis evidence, and unreviewed community provenance. Re-score only after a payload-bound rubric audit.

This is a limitation of the numeric assessment, not a measured absence of benefit. It does not re-review the separately recorded catalogue classification or establish efficacy or safety.

  • Study identity requires review
  • Evidence applicability requires review
  • Assessment incomplete
  • Community provenance requires review
  • Scoring method unresolved

Status date:

Scoring context and limitations
✓
Evidence Level
high
US EGRIFTA WR labeling revised March 2025: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy only.
FDA Approved
Identity
SCALE · 1:1 N-TERMINUS C-TERMINUS 44 AA · 5,135.87 Da
Also Known As
Egrifta • Egrifta SV • Egrifta WR • TH9507
Class
Modified GHRH Analog
Length
44 amino acids
Mol. weight
5,135.87 Da
Sequence
hex-YADAIFTNSYRKVLGQLSARKLLQDIMSRQQGESNQERGARARL-NH2
Molecular Structure
hex
Y
A
D
A
I
F
T
N
S
Y
R
K
V
L
G
Q
L
S
A
R
K
L
L
Q
D
I
M
S
R
Q
Q
G
E
S
N
Q
E
R
G
A
R
A
R
L
Hydrophobic
Polar
Positive
Negative

Tesamorelin is a synthetic GHRH analog. The strongest direct evidence is for reducing CT-measured visceral abdominal fat in adults with HIV-associated lipodystrophy, the population named in the US EGRIFTA WR indication. In the 2007 pivotal trial, VAT changed -15.2% with tesamorelin and +5.0% with placebo at 26 weeks. Those figures describe VAT, not trunk fat. The second pivotal trial and the pooled analysis support the same population and endpoint; the pooled report reuses the trial participants. FDA label, PMID:18057338, PMID:20101189, PMID:20554713.

How it works and what was measured

The FDA label describes receptor binding, pulsatile endogenous GH release, and increases in IGF-1. The pivotal trials then measured VAT by CT. This supports the causal chain through an imaging endpoint in the indicated population; it does not establish better cardiovascular outcomes or safer GH replacement. The 2007 trial’s 81% IGF-1 increase is a biomarker result from that trial, not a general expected response. FDA label, sections 12 and 14, PMID:18057338.

Findings outside the approved indication

In a 60-person randomized study of abdominal obesity with reduced GH secretion, VAT fell relative to placebo. This does not establish an indication for general obesity. In a separate HIV-associated NAFLD trial, hepatic fat fraction fell over 12 months and fibrosis progression was less frequent in a small paired-biopsy subset. Related transcriptomic and proteomic publications analyzed the same trial, not new patient cohorts. A completed non-HIV fatty liver study has posted registry results, with only 18 and 16 participants in the two primary outcome analyses; the clinical importance needs independent review. Tesamorelin is not FDA-approved for fatty liver disease. PMID:23015655, PMID:25038357, PMID:31611038, PMID:32701508, PMID:32270862, PMID:34006921, NCT03375788.

A 73-person open-label HIV cognition trial reported no significant between-group cognitive benefit at six months (P=.673). An earlier trial in older adults reported a favorable signal, but a 2026 placebo-controlled 22-person pilot found no significant direct changes in its study measures. Neither establishes a cognitive indication. PMID:39813152, PMID:22869065, PMID:42382101.

Safety and regulatory limits

The March 2025 EGRIFTA WR label lists contraindications for hypothalamic- pituitary-axis disruption, active malignancy, known hypersensitivity, and pregnancy. It warns about persistent IGF-1 elevation, glucose intolerance or diabetes, fluid retention, hypersensitivity, injection-site reactions, and acute critical illness. It identifies potential interactions with drugs metabolized by CYP450 enzymes and with glucocorticoid replacement. The label does not provide tesamorelin-specific evidence for combining it with other GH secretagogues or incretin therapies. EGRIFTA WR and SV are distinct, non-substitutable formulations. FDA EGRIFTA WR label.

This page summarizes research and labeling. It does not provide treatment, dosing, preparation, or purchasing guidance.

Selected source records

The source count above is 35 distinct cited records: 13 publications, 20 real ClinicalTrials.gov records, the FDA WR label, and its current DailyMed set. The 13 publications are not 13 independent trials. The key primary records are the 2007 pivotal trial, 2010 second pivotal trial, pooled pivotal report, non-HIV obesity trial, 2014 HIV liver-fat trial, 2019 HIV-NAFLD trial, HIV cognition trial, older-adult cognition trial, and 2026 cognition pilot. The selected follow-up analyses are the HIV-NAFLD fibrosis predictor, biopsy-transcriptomic, and plasma-proteomic reports. A 2026 tesamorelin-specific meta-analysis combines earlier trials and is not an independent cohort. The FDA EGRIFTA WR label and current DailyMed WR set are two versioned regulatory label records. The 20 official registry records below are counted once each and are distinct from the 13 publications.

These 20 non-mock records are linked for provenance. Their statuses and dates can change; a registry listing alone is not clinical outcome evidence. NCT07481734 is excluded because its brief title and detailed description identify a mock study.

NCT00123253, NCT00257712, NCT00608023, NCT00675506, NCT00795210, NCT00850564, NCT01263717, NCT01264497, NCT01388920, NCT01591902, NCT01632592, NCT02012556, NCT02196831, NCT02553603, NCT02572323, NCT02931474, NCT03150511, NCT03226821, NCT03375788, NCT06554717.

Tesamorelin concentration calculator provides educational mass-volume arithmetic only; it does not select a dose or provide a treatment schedule.

i. GHRH receptor signaling · GH release
TesamorelinPituitary GHRH receptor stimulationEndogenous GH releaseIncreased IGF-1GH and IGF-1 rise; IGF-1 elevation requires safety monitoring
ii. VAT outcome in the pivotal HIV trials · Imaging endpoint
Tesamorelin exposure in randomized adults with HIV lipodystrophyCT measurement at 26 weeksLower visceral adipose tissue than placebo
Mechanism Tesamorelin binds pituitary GHRH receptors and increases endogenous growth hormone and IGF-1; the pivotal endpoint is CT-measured VAT.
Established 2 direct studies
Benefit shown to reduce excess visceral abdominal fat in adults with HIV lipodystrophy
Evidence Level
High
2 Human
Mechanism GH-axis activation changes body composition, but the clinical consequence of lean-mass change is not established by these trials.
Supported 2 direct studies
Benefit shown to increase measured lean body mass in the pivotal HIV trials
Evidence Level
Moderate
2 Human
Mechanism Liver-fat imaging and biopsy outcomes were investigated in a small randomized HIV-associated NAFLD trial.
Supported 1 direct study
Benefit appears to reduce hepatic fat fraction in adults with HIV-associated NAFLD
Evidence Level
Low
1 Human
Mechanism Paired liver-biopsy and blood-marker analyses from the same HIV-NAFLD trial described pathway changes; they do not add independent cohorts.
Supported 1 direct study
Benefit appears to reduce observed fibrosis progression over one year in the HIV-NAFLD trial
Evidence Level
Low
1 Human
Mechanism Confidence
Established
Supported
Emerging
Evidence Level
High
Moderate
Low
Very Low
  1. 001

    FDA approval and high-grade evidence are restricted to reducing excess abdominal fat in adults with HIV-associated lipodystrophy.

  2. 002

    Long-term cardiovascular safety and clinical benefit from VAT change are unestablished in the FDA label; EGRIFTA WR is weight neutral.

  3. 003

    Elevated IGF-1, glucose intolerance/diabetes, fluid retention, hypersensitivity, injection-site reactions, and neoplasm precautions are material safety issues in the current label.

  4. 004

    Liver and cognitive publications include small populations, secondary analyses, and an inconclusive between-group cognition result.

NCT ID Title Peptide Phase Status Completion
NCT06554717
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
HIV-1-infection, Frailty +3 more
Tesamorelin Phase 2 Recruiting Dec 2028 (estimated)
NCT03375788
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Non-Alcoholic Fatty Liver Disease, Obesity +3 more
Tesamorelin Phase 2 Completed Jan 2025
NCT03150511
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Peripheral Nerve Injuries
Tesamorelin Phase 2 Recruiting Dec 2027 (estimated)
NCT03226821
Body Composition and Adipose Tissue in HIV
HIV Lipodystrophy Syndrome, Growth Hormone Deficiency +1 more
Tesamorelin Phase 4 Terminated Apr 2025
NCT02553603
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Mild Cognitive Impairment
Tesamorelin Phase 1 Completed Jan 2019
NCT02572323
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
Mild Cognitive Impairment
Tesamorelin Phase 2 Completed Oct 2023
NCT02931474
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
Sleep Disorder, Traumatic Brain Injury
Tesamorelin Phase 2 Withdrawn Mar 2017
NCT02196831
Tesamorelin Effects on Liver Fat and Histology in HIV
Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD) +1 more
Tesamorelin Phase N/A Completed Jul 2019
NCT01632592
Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
Abdominal Obesity
Tesamorelin Phase N/A Withdrawn Jan 2014
NCT01591902
Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
Diabetic Retinopathy, HIV
Tesamorelin Phase 4 Terminated Aug 2018
NCT01388920
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Chronic Obstructive Pulmonary Disease (COPD)
Tesamorelin Phase 2 Terminated Dec 2011
NCT01263717
Effects of Growth Hormone Releasing Hormone in HIV
HIV, HIV Lipodystrophy
Tesamorelin Phase N/A Completed Feb 2014
NCT00795210
Effects of Short-term Growth Hormone in HIV-infected Patients
HIV Lipodystrophy
Tesamorelin Phase N/A Completed Nov 2012
NCT00850564
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Healthy Volunteers
Tesamorelin Phase N/A Completed Apr 2010
NCT00675506
Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
Abdominal Obesity, Growth Hormone Deficiency
Tesamorelin Phase 2 Completed Jan 2012
NCT02012556
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
HIV
Tesamorelin Phase 1 Completed Jul 2008
NCT00608023
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Lipodystrophy, HIV Infections
Tesamorelin Phase 3 Completed Oct 2008
NCT00257712
SMART: Somatotrophics, Memory, and Aging Research Trial
Aging, Mild Cognitive Impairment
Tesamorelin Phase 2 Completed Dec 2011
NCT00123253
TH9507 in Patients With HIV-Associated Lipodystrophy
HIV Infections, Lipodystrophy
Tesamorelin Phase 3 Completed Apr 2007
NCT01264497
Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes
Type 2 Diabetes
Tesamorelin Phase 2 Completed Nov 2002
NCT06554717 Recruiting

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

Tesamorelin Phase 2 Completion: Dec 2028 (estimated)
NCT03375788 Completed

Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk

Tesamorelin Phase 2 Completion: Jan 2025
NCT03150511 Recruiting

Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury

Tesamorelin Phase 2 Completion: Dec 2027 (estimated)
NCT03226821 Terminated

Body Composition and Adipose Tissue in HIV

Tesamorelin Phase 4 Completion: Apr 2025
NCT02553603 Completed

The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment

Tesamorelin Phase 1 Completion: Jan 2019
NCT02572323 Completed

Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

Tesamorelin Phase 2 Completion: Oct 2023
NCT02931474 Withdrawn

Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

Tesamorelin Phase 2 Completion: Mar 2017
NCT02196831 Completed

Tesamorelin Effects on Liver Fat and Histology in HIV

Tesamorelin Phase N/A Completion: Jul 2019
NCT01632592 Withdrawn

Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue

Tesamorelin Phase N/A Completion: Jan 2014
NCT01591902 Terminated

Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

Tesamorelin Phase 4 Completion: Aug 2018
NCT01388920 Terminated

Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting

Tesamorelin Phase 2 Completion: Dec 2011
NCT01263717 Completed

Effects of Growth Hormone Releasing Hormone in HIV

Tesamorelin Phase N/A Completion: Feb 2014
NCT00795210 Completed

Effects of Short-term Growth Hormone in HIV-infected Patients

Tesamorelin Phase N/A Completion: Nov 2012
NCT00850564 Completed

Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Tesamorelin Phase N/A Completion: Apr 2010
NCT00675506 Completed

Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese

Tesamorelin Phase 2 Completion: Jan 2012
NCT02012556 Completed

Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients

Tesamorelin Phase 1 Completion: Jul 2008
NCT00608023 Completed

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Tesamorelin Phase 3 Completion: Oct 2008
NCT00257712 Completed

SMART: Somatotrophics, Memory, and Aging Research Trial

Tesamorelin Phase 2 Completion: Dec 2011
NCT00123253 Completed

TH9507 in Patients With HIV-Associated Lipodystrophy

Tesamorelin Phase 3 Completion: Apr 2007
NCT01264497 Completed

Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes

Tesamorelin Phase 2 Completion: Nov 2002
Phase 01 1
Week 26 in pivotal trials

CT-measured VAT was lower than placebo in two randomized HIV lipodystrophy trials. Trunk-fat and lean-mass measures also changed, but these are distinct endpoints.

Phase 02 2
Week 52 extension

In participants continuing tesamorelin, VAT reduction was maintained; those switched to placebo rapidly lost the earlier VAT improvement. These are extension observations, not a personal response schedule.

Research-based observations

This timeline reflects observations from published clinical and preclinical studies. Individual responses may vary significantly. This is not a guarantee of effects or a dosing schedule. Consult qualified healthcare providers for personalized guidance.

35 Sources 13 Human 0 Preclinical

Key Studies Cited

RCT Falutz et al., N Engl J Med, 2007
PMID:18057338
RCT Falutz et al., J Acquir Immune Defic Syndr, 2010
PMID:20101189
Meta Falutz et al., J Clin Endocrinol Metab, 2010
PMID:20554713
RCT Stanley et al., Lancet HIV, 2019
PMID:31611038
RCT Stanley et al., JAMA, 2014
PMID:25038357
Human Fourman et al., JCI Insight, 2020
PMID:32701508
Human Fourman et al., Scientific Reports, 2021
PMID:34006921

Use the source links in the research discussion above to inspect the referenced records.

This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength labels summarize the cited material for this entry and should be read alongside its population, model, and study limitations.

For complete methodology details, see our Methodology page.

Important Disclaimer

This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.

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Safety profile Tesamorelin: adverse events, contraindications and monitoring →

Compared With

5 comparisons

Conditions Studied

6 entries

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Guide

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