tesamorelin: Clinical Trials

21 trials of tesamorelin, newest first

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11 completed, 4 terminated, 3 recruiting, 3 withdrawn. 9 Phase 2, 4 Not applicable, 2 Phase 1, 2 Phase 3, 2 Phase 4.

By phase and status

PhaseTrialsStatus
Phase 29Completed 4, Recruiting 3, Terminated 1, Withdrawn 1
Not applicable4Completed 3, Withdrawn 1
Phase 12Completed 2
Phase 32Completed 2
Phase 42Terminated 2

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Tesamorelin, Placebo, Standardized lifestyle counseling - Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis
Phase 2RecruitingHudson Biotech1202026-02-022026-03-19
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Tesamorelin, Placebo, Exercise - HIV-1-infection, Frailty
Phase 2RecruitingMassachusetts General Hospital1002025-07-102026-05-19
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Tesamorelin, Identical Placebo - Non-Alcoholic Fatty Liver Disease, Obesity
Phase 2CompletedMassachusetts General Hospital512019-01-172025-11-20
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
Tesamorelin 2 Milligrams (MG) - Peripheral Nerve Injuries
Phase 2RecruitingJohns Hopkins University362018-06-012025-11-12
Body Composition and Adipose Tissue in HIV
Tesamorelin - HIV Lipodystrophy Syndrome, Growth Hormone Deficiency
Phase 4TerminatedColumbia University62018-02-072026-05-19
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Growth Hormone Releasing Hormone (GHRH), Placebo Growth Hormone Releasing Hormone - Mild Cognitive Impairment
Phase 1CompletedThe University of Texas Medical Branch, Galveston222017-07-182019-11-04
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
Tesamorelin - Mild Cognitive Impairment
Phase 2CompletedUniversity of California, San Diego732017-02-152026-03-12
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
Tesamorelin, Placebo - Sleep Disorder, Traumatic Brain Injury
Phase 2WithdrawnNational Institute of Nursing Research (NINR)2016-10-062019-11-19
Tesamorelin Effects on Liver Fat and Histology in HIV
tesamorelin, Placebo - Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD)
Not applicableCompletedMassachusetts General Hospital612015-07-012020-01-27
Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
Tesamorelin, Placebo - Abdominal Obesity
Not applicableWithdrawnMassachusetts General Hospital2014-01-012014-01-24
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
Tesamorelin for injection - HIV
TerminatedTheratechnologies3912013-02-012018-09-11
Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
Tesamorelin, Placebo-Control - Diabetic Retinopathy, HIV
Phase 4TerminatedTheratechnologies1292012-06-012018-09-11
Egrifta Replacement and Sleep Disordered Breathing
Tesamorelin (Egrifta) - Lipodystrophy
WithdrawnJohns Hopkins University2012-05-012017-03-03
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Tesamorelin, Placebo - Chronic Obstructive Pulmonary Disease (COPD)
Phase 2TerminatedTheratechnologies32011-09-012022-03-18
Effects of Growth Hormone Releasing Hormone in HIV
tesamorelin, placebo - HIV, HIV Lipodystrophy
Not applicableCompletedMassachusetts General Hospital542010-12-012017-10-30
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Growth Hormone Releasing Hormone (Tesamorelin) - Healthy Volunteers
Not applicableCompletedMassachusetts General Hospital152009-02-012011-04-19
Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese
Growth hormone releasing hormone (GHRH) 1-44, Placebo - Abdominal Obesity, Growth Hormone Deficiency
Phase 2CompletedMassachusetts General Hospital602008-07-012017-12-13
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
Tesamorelin - HIV
Phase 1CompletedTheratechnologies182008-05-012013-12-16
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Tesamorelin, Placebo for Tesamorelin - Lipodystrophy, HIV Infections
Phase 3CompletedTheratechnologies2632007-08-012022-09-30
TH9507 in Patients With HIV-Associated Lipodystrophy
TH9507 - HIV Infections, Lipodystrophy
Phase 3CompletedTheratechnologies4122005-06-012013-11-27

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Conditions studied

Lipodystrophy (4)  ·  Obesity, Abdominal (4)  ·  Non-alcoholic Fatty Liver Disease (3)  ·  Cognitive Dysfunction (2)  ·  Dwarfism, Pituitary (2)  ·  Fatty Liver (2)  ·  HIV Infections (2)  ·  HIV-Associated Lipodystrophy Syndrome (2)  ·  Acquired Immunodeficiency Syndrome (1)  ·  Brain Injuries, Traumatic (1)  ·  Diabetes Mellitus, Type 2 (1)  ·  Diabetic Retinopathy (1)  ·  Fibrosis (1)  ·  Frailty (1)  ·  Muscular Atrophy (1)

Sponsors

Massachusetts General Hospital (7)  ·  Theratechnologies (7)  ·  Johns Hopkins University (2)  ·  Columbia University (1)  ·  Hudson Biotech (1)  ·  National Institute of Nursing Research (NINR) (1)  ·  The University of Texas Medical Branch, Galveston (1)  ·  University of California, San Diego (1)

Countries

United States (16)  ·  Canada (3)  ·  Belgium (1)  ·  China (1)  ·  France (1)  ·  Spain (1)  ·  United Kingdom (1)

Top investigators

Steven Grinspoon, MD (4)  ·  Fred Sattler, MD (1)  ·  Jean-Claude Mamputu, PhD (1)  ·  Jessica Gill, Ph.D. (1)  ·  Kristine M. Erlandson, MD (1)  ·  Lindsay T. Fourman, MD (1)  ·  Marilyn De Chantal (1)  ·  Pamela U. Freda, MD (1)  ·  Philip L Smith, M.D. (1)  ·  Randall J Urban, MD (1)  ·  Richard Casaburi, PhD, MD (1)  ·  Richard Larouche, MD (1)  ·  Ronald J Ellis, MD, PhD (1)  ·  Sami Tuffaha, MD (1)  ·  Steven K Grinspoon, M.D. (1)

Results publications

PMID 20101189, PMID 20554713, PMID 22495074, PMID 28832410, PMID 18057338, PMID 20943777, PMID 21531600, PMID 23015655, PMID 24178787, PMID 24291224, PMID 25038357, PMID 28617838, PMID 29031905, PMID 31611038, PMID 33125080, PMID 33852720, PMID 34006921, PMID 42382101, PMID 42419889

NIH funding

R01DK063639 (1), R01DK110771 (1), R01HL085268 (1), U01AI115711 (1)