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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR EGRIFTA

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Clinical Trials for Egrifta

Trial ID Title Status Sponsor Phase Summary
NCT00608023 TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy Completed Theratechnologies Phase 3 HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
NCT01579695 Long-term Observational Study in HIV Subjects Exposed to EGRIFTA® Recruiting Theratechnologies N/A The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
NCT01591902 Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA® Recruiting Theratechnologies Phase 4 To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
NCT01788462 Egrifta Replacement and Sleep Disordered Breathing Suspended Johns Hopkins University N/A Sleep-disordered breathing is characterized primarily by partial or total upper airway obstruction during sleep. The most common form of sleep-disordered breathing is obstructive sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep state. The major risk factors associated with the development of sleep apnea are obesity and male sex. The investigators have also found a high prevalence of OSA in HIV infected men and women, particularly among those with central lipohypertrophy, which is a common finding in HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters both mechanical properties and compensatory neuromuscular responses leading to upper airway obstruction. Based on our most recent findings in the non-HIV population, the investigators demonstrate that obesity is associated with elevations in the upper airway load (passive Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the investigators have found that female sex, peripheral adiposity, and younger age are associated with increased compensatory neuromuscular responses, while male sex, central adiposity, and older age are associated with blunted compensatory responses. The loss of the compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The investigators hypothesize that tesamorelin therapy will reverse both the mechanical and neurocompensatory alterations associated with increased central obesity. In this project the investigators will determine whether tesamorelin affects sleep apnea severity and compensatory neuromuscular responses of the upper airway on sleep and breathing in men and women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic basis for the development of obstructive sleep apnea in this population. The studies also provide insights into the neurohumoral regulation of upper airway function, and potentially new approaches to the treatment for sleep-disordered breathing.
NCT02012556 Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients Completed Theratechnologies Phase 1 The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.
NCT02196831 Tesamorelin Effects on Liver Fat and Histology in HIV Recruiting National Institute of Allergy and Infectious Diseases (NIAID) N/A Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Egrifta

Condition Name

Condition Name for Egrifta
Intervention Trials
HIV 3
Mild Cognitive Impairment 2
Lipodystrophy 2
HIV Lipodystrophy Syndrome 1
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Condition MeSH

Condition MeSH for Egrifta
Intervention Trials
Lipodystrophy 3
HIV-Associated Lipodystrophy Syndrome 2
HIV Infections 2
Mild Cognitive Impairment 2
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Clinical Trial Locations for Egrifta

Trials by Country

Trials by Country for Egrifta
Location Trials
United States 47
Canada 4
Belgium 1
United Kingdom 1
Spain 1
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Trials by US State

Trials by US State for Egrifta
Location Trials
California 4
Texas 4
Florida 3
Washington 3
New York 3
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Clinical Trial Progress for Egrifta

Clinical Trial Phase

Clinical Trial Phase for Egrifta
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Egrifta
Clinical Trial Phase Trials
Recruiting 5
Completed 2
Not yet recruiting 2
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Clinical Trial Sponsors for Egrifta

Sponsor Name

Sponsor Name for Egrifta
Sponsor Trials
Theratechnologies 4
Johns Hopkins University 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1
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Sponsor Type

Sponsor Type for Egrifta
Sponsor Trials
Other 7
Industry 4
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Dow
Medtronic
US Department of Justice
AstraZeneca
Boehringer Ingelheim
Deloitte
UBS
Farmers Insurance

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