Tesamorelin

Tesamorelin is a synthetic analog of GHRH approved by the FDA in 2010 specifically for reducing excess abdominal fat in HIV-infected patients with lipodystrophy. Unlike general GH stimulation, it was developed specifically for this indication with extensive safety data in immunocompromised populations.

PubMed results: 85 · Human studies: 68 · Animal studies: 68

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

FDA-approved dosing for HIV-associated lipodystrophy

• Subcutaneous Injection — standard range 2 mg, Once daily

26-38 minutes (high confidence)

• NCT00850564 — Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men (NA), status: COMPLETED. Indications: Healthy Volunteers
• NCT00123253 — TH9507 in Patients With HIV-Associated Lipodystrophy (PHASE3), status: COMPLETED. Indications: HIV Infections, Lipodystrophy
• NCT00608023 — TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy (PHASE3), status: COMPLETED. Indications: Lipodystrophy, HIV Infections
• NCT01264497 — Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes (PHASE2), status: COMPLETED. Indications: Type 2 Diabetes
• NCT01591902 — Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA® (PHASE4), status: TERMINATED. Indications: Diabetic Retinopathy, HIV
• NCT02196831 — Tesamorelin Effects on Liver Fat and Histology in HIV (NA), status: COMPLETED. Indications: Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
• NCT01632592 — Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue (NA), status: WITHDRAWN. Indications: Abdominal Obesity
• NCT03226821 — Body Composition and Adipose Tissue in HIV (PHASE4), status: COMPLETED. Indications: HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition
• NCT06554717 — Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (PHASE2), status: RECRUITING. Indications: HIV-1-infection, Frailty, Impaired Physical Function, Abdominal Obesity, Aging
• NCT07481734 — Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study) (PHASE2), status: RECRUITING. Indications: Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis
• NCT00795210 — Effects of Short-term Growth Hormone in HIV-infected Patients (NA), status: COMPLETED. Indications: HIV Lipodystrophy
• NCT02012556 — Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients (PHASE1), status: COMPLETED. Indications: HIV
• NCT00675506 — Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese (PHASE2), status: COMPLETED. Indications: Abdominal Obesity, Growth Hormone Deficiency
• NCT00257712 — SMART: Somatotrophics, Memory, and Aging Research Trial (PHASE2), status: COMPLETED. Indications: Aging, Mild Cognitive Impairment
• NCT01388920 — Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting (PHASE2), status: TERMINATED. Indications: Chronic Obstructive Pulmonary Disease (COPD)
• NCT01263717 — Effects of Growth Hormone Releasing Hormone in HIV (NA), status: COMPLETED. Indications: HIV, HIV Lipodystrophy
• NCT02931474 — Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia (PHASE2), status: WITHDRAWN. Indications: Sleep Disorder, Traumatic Brain Injury
• NCT02553603 — The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment (PHASE1), status: COMPLETED. Indications: Mild Cognitive Impairment
• NCT03375788 — Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (PHASE2), status: COMPLETED. Indications: Non-Alcoholic Fatty Liver Disease, Obesity, Obesity, Abdominal, Liver Fat, Fatty Liver
• NCT03826160 — Growth Hormone Dynamics and Cardiac Steatosis in HIV, status: COMPLETED. Indications: Human Immunodeficiency Virus, Lipodystrophy, Cardiac Disease