RCTNCT00123253Phase 3 · 2005 · n=412 · Theratechnologies HIV-associated lipodystrophy — visceral fat reduction
tested Visceral adipose tissue (VAT)
result Completed; results not posted
RCTNCT00257712Phase 2 · 2006 · n=151 · University of Washington Cognitive function in aging
tested Change in declarative memory, including total recall scores on three tests of memory and on dual task response time (RT), a test of executive function.
result Completed; results not posted
RCTNCT00608023Phase 3 · 2007 · n=263 · Theratechnologies HIV-associated lipodystrophy — visceral fat reduction
tested Changes From Baseline in Fasting Blood Glucose at Week 52
result −41.0 cm^2 (Changes From Baseline in Visceral Adipose Tissue (…)
RCTNCT012637172010 · n=54 · Massachusetts General Hospital HIV-associated lipodystrophy — visceral fat reduction
tested Liver Fat
result −42.0 change in cm^2 after 6 months (Visceral Adipose Tissue)
RCTNCT01264497Phase 2 · 2002 · n=55 · Theratechnologies Type 2 Diabetes
tested Change from baseline in relative insulin response
result Completed; results not posted
Chronic Obstructive Pulmonary Disease (COPD)
tested Change From Baseline in Lean Body Mass at 6 Months
result Terminated before completion
Terminated: The study was terminated based on a non-safety related corporate decision.
RCTNCT01591902Phase 4 · 2012 · n=129 · Theratechnologies HIV-associated lipodystrophy — visceral fat reduction
tested Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale.
result Terminated before completion
Abdominal Obesity
tested aortic "target to background ratio" (Aortic TBR)
result Withdrawn before enrolment
Withdrawn: No funding available
RCTNCT021968312015 · n=61 · Massachusetts General Hospital HIV-associated lipodystrophy — visceral fat reduction
tested Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy
result −4.7 percent (hepatic fat fraction) (Change in Liver Fat as Measured by 1-H Magnetic Re…)
RCTNCT02572323Phase 2 · 2017 · n=73 · University of California, San Diego Cognitive function in aging
tested Change in Neurocognitive Performance
RCTNCT02931474Phase 2 · 2016 · National Institute of Nursing Research (NINR) Sleep Disorder
tested Change in NREM time following tesamorelin administration compared to placebo
result Withdrawn before enrolment
Withdrawn before enrolment; no public reason provided.
RCTNCT03150511Phase 2 · 2018 · n=36 · Johns Hopkins University Peripheral Nerve Injuries
tested 3-point chuck pinch test
result In progress (recruiting)
RCTNCT03375788Phase 2 · 2019 · n=51 · Massachusetts General Hospital NAFLD / steatotic liver disease — hepatic fat reduction
tested Liver Fat Content
result −8.9 percent change in hepatic fat fraction (Liver Fat Content)
RCTNCT06554717Phase 2 · 2025 · n=100 · Massachusetts General Hospital HIV-associated lipodystrophy — visceral fat reduction
tested Change in Repeated Chair Stand Time
result In progress (recruiting)
NAFLD / steatotic liver disease — hepatic fat reduction
tested Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)
result In progress (recruiting)
Treatment studies
tested VAT reduction, waist circumference, IGF-1, metabolic parameters
result Tesamorelin responders (≥8% VAT decrease) showed VAT reduction and improved waist circumference at week 26 in both dorsocervical fat and non-dorsocervical fat groups.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Circulating immune biomarkers (Olink panel, 92 proteins) and hepatic immune gene pathways (liver biopsy transcriptomics)
result Tesamorelin decreased 13 immune proteins vs placebo (CCL3 -0.38, CCL4 -0.36, IL-8 -0.50, granzyme A -0.53, ADGRG1 -0.54 Log2FC); liver biopsy confirmed downregulated immune pathways.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested change in abdominal fat (DXA, CT), IGF-I, metabolic parameters, quality of life, safety
result 2 mg: trunk fat -9.2% vs +0.8% placebo (P=0.014); IGF-I +65% (P<0.01); triglycerides and chol/HDL decreased significantly; VAT -15.7% (NS); no glucose change.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested visceral adipose tissue (VAT), triglycerides, cholesterol, HDL, glucose parameters, adverse events over 52 weeks
result VAT sustained at -18% over 52 weeks (P<0.001 vs baseline); triglycerides -51 mg/dl (P<0.001); HDL decreased minimally; VAT reaccumulated upon discontinuation.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested percent change in visceral adipose tissue (VAT) by CT scan at week 26
result VAT decreased -24±41 vs 2±35 cm² (P<0.001; treatment effect -15.4%); triglycerides -12.3%; sustained at wk 52 (-17.5%). IGF-I +108±112 ng/ml vs -7±64 (P<0.001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Inflammatory and fibrinolytic markers (PAI-1, tPA antigen, CRP, adiponectin) and their relationship to VAT reduction
result tPA antigen decreased significantly (-2.2 vs -1.5 ng/ml, P<0.05); PAI-1 change not significant; inflammatory marker changes correlated with VAT reduction.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested VAT reduction ≥8% (responder) associated with triglyceride, glucose, HbA1c, and adiponectin changes over 26-52 weeks
result Responders vs non-responders: TG -0.6 vs -0.1 mmol/L at 26wk (P=.005); fasting glucose 1 vs 5 mg/dL at 26wk (P=.01); HbA1c 0.1 vs 0.3% at 26wk (P<.001); adiponectin improved in responders.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested VAT, cIMT, CRP, triglycerides, IGF-I, glucose, HbA1c
result VAT −35 cm² (P=0.003), cIMT −0.04 mm (P=0.02), triglycerides −37 mg/dL (P=0.02), log-CRP −0.15 (P=0.04), IGF-I +92 µg/L (P<0.0001); no effect on sc fat or glucose.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested phosphocreatine recovery (mitochondrial function) assessed by 31P MRS
result IGF-I increased 102.9±31.8 μg/L (tesamorelin) vs 22.8±8.9 μg/L (placebo; P=.02); IGF-I increases correlated with PCr recovery improvements (R=0.71, P=.03 in tesamorelin group).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Visceral adipose tissue (VAT) and liver fat (lipid-to-water %)
result VAT: -34 cm² vs +8 cm² (treatment effect -42 cm², P=.005); liver fat: -2.0% vs +0.9% lipid/water (net effect -2.9%, P=.003) at 6 months.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested VAT reduction at 3 and 6 months; odds of VAT <140 cm²
result Odds of VAT <140 cm² was 3.9x greater for tesamorelin vs placebo (95% CI 2.03–7.44); MetS-NCEP, triglycerides >1.7 mmol/L, white race predicted response at 6 months.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Relative insulin response following oral glucose ingestion; fasting glucose, HbA1c, lipids
result No significant difference in insulin response or glycemic control vs placebo at 12 weeks. Tesamorelin 2 mg reduced total cholesterol −0.3±0.6 mmol/L and non-HDL −0.3±0.5 mmol/L (p<0.05).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Changes in ALT and AST among VAT responders vs nonresponders over 26 and 52 weeks
result VAT responders: ALT -8.9±22.6 vs +1.4±34.7 U/l (P=0.004); AST -3.8±12.9 vs +0.4±22.4 U/l (P=0.04) vs nonresponders at 26 wks; improvement persisted at 52 wks.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Skeletal muscle density (Hounsfield Units) and area (cm²) across four truncal muscle groups at 26 weeks
result Tesamorelin vs placebo: muscle density +1.56–4.86 HU across 4 truncal groups (p<0.005); lean muscle area +0.64–1.08 cm² all 4 groups (p<0.005); rectus+psoas total area +0.44–0.46 cm².
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change in hepatic fat fraction (HFF) at 12 months; secondary: glucose, HbA1c
result Tesamorelin reduced HFF by -4.1% absolute (95% CI -7.6 to -0.7, p=0.018), -37% relative vs placebo; 35% vs 4% achieved HFF <5% (p=0.0069).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Hepatic fibrosis presence and progression over 12 months; visceral fat as predictor
result 43% had baseline fibrosis; 38% of placebo group progressed over 12 months; each 25 cm² higher visceral fat raised fibrosis progression odds by 37% (OR 1.37, 95% CI 1.03–2.07).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Hepatic transcriptomic gene expression (oxidative phosphorylation, inflammation, fibrosis-related gene score)
result Tesamorelin increased oxidative phosphorylation gene sets, decreased inflammation/tissue-repair/cell-division sets, and up/downregulated HCC prognosis gene sets correlating with improved fibrosis-related gene score.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Visceral and subcutaneous adipose tissue density (Hounsfield Units on CT) over 26 weeks
result VAT density +6.2 HU (tesamorelin) vs +0.3 HU (placebo), P<0.0001; SAT density +4.0 HU vs +0.3 HU, P<0.0001; effects persisted after controlling for fat area changes.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Circulating immune activation markers (92 plasma biomarkers) and hepatic immune gene pathways via liver biopsy transcriptomics
result Tesamorelin decreased 13 circulating proteins (CCL3, CCL4, CCL13, IL-8, IL-10, CSF-1, CD8A, CRTAM, GZMA, ADGRG1, ARG1, Gal-9, HGF); no proteins increased. Liver transcriptomics confirmed down-regulated immune activation pathways.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Plasma VEGFA, TGFB1, CSF1 levels; NAFLD activity score; gene-level fibrosis score
result Tesamorelin reduced VEGFA (log2-FC −0.20±0.35 vs 0.05±0.34, P=0.02), TGFB1 (−0.35±0.56 vs −0.05±0.43, P=0.05), CSF1 (−0.17±0.21 vs 0.02±0.20, P=0.004) vs placebo; reductions correlated with lower NAFLD activity score and fibrosis score.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested VAT and waist circumference reduction at 26 weeks
result Among tesamorelin responders, VAT and WC decreased in both dorsocervical fat groups with no significant difference between groups (VAT P=0.657, WC P=0.093).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Visceral fat area, hepatic fat fraction, trunk-to-appendicular fat ratio, metabolic and safety outcomes at 12 months
result Visceral fat: -25 vs +14 cm² (P=0.001); hepatic fat: -4.2% vs -0.5% (P=0.01); trunk-to-appendicular fat ratio: -0.1 vs 0.0 (P=0.03) at 12 months.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Change in neurocognitive performance at 6 months; secondary: waist circumference, mood, daily functioning
result Tesamorelin trended toward improved cognition (mean +0.146, P=.060) vs SOC (+0.103, P=.295); between-group difference not significant (P=.673). WC reduced more with tesamorelin (median −2.7 cm, P=.015).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
OpenNCT008505642009 · n=15 · Massachusetts General Hospital Pharmacokinetic / healthy volunteer studies
tested Mean Overnight Growth Hormone
Non-randomised; effect size cannot be separated from placebo.
HIV-associated lipodystrophy — visceral fat reduction
tested Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®
result Terminated before completion
HIV-associated lipodystrophy — visceral fat reduction
tested Changes in Sleep Apnea Severity
result Withdrawn before enrolment
Withdrawn: Lack of funding.
OpenNCT02012556Phase 1 · 2008 · n=18 · Theratechnologies HIV-associated lipodystrophy — visceral fat reduction
tested Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin.
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT03226821Phase 4 · 2018 · n=6 · Columbia University HIV-associated lipodystrophy — visceral fat reduction
tested Hepatic Lipid Content
result Terminated before completion
Terminated: lack of availability of the study drug
Treatment studies
tested waist circumference, visceral adipose tissue (VAT), body image
result Two Phase 3 RCTs: tesamorelin significantly decreased waist circumference and VAT after 26 weeks; improvements maintained through 52 weeks without adverse effects on glucose or lipids.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Pharmacokinetic parameters (clearance, volume of distribution, absorption)
result Clearance 1060 L/h (33.6% IIV), Vd 200 L (17.7%); first-order absorption fraction 13.1% higher on day 14 vs day 1; no clinically relevant PK covariates identified.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Time course of GH and IGF-1 concentrations characterized via sequential population PK/PD model
result Sequential PK/PD model accurately predicted GH and IGF-1 time courses after 1–2 mg SC daily ×14 days in 41 subjects; no covariates significantly affected GH or IGF-1 model parameters.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested pharmacokinetics of simvastatin and ritonavir (AUC0-t, AUC0-inf, Cmax)
result Simvastatin AUC/Cmax ratios within 80-125% no-effect range. Ritonavir AUCs within range; Cmax lower CI 74.8% (~90% ratio). No dose adjustment required.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested Waist circumference, lipid levels, functional well-being, visceral adiposity
result Tesamorelin markedly reduced WC, improved lipids, and enhanced well-being in nonobese PLWH; provided targeted visceral fat reduction in obese PLWH with intermittent GLP-1 access.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested rodent · Combined antiretroviral therapy with low- or normal-protein, high-calorie diets appears to induce significant deleterious electrocardiographic changes in a rodent model.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.