VRS-317 in Adult Subjects With Growth Hormone Deficiency
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients.
* Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase)
* Descriptive pharmacok
Study InterventionsVRS-317, VRS-317, VRS-317Primary EndpointsSafety and Tolerability of single dose of VRS-317Study Period2011-03 → 2012-07 Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
Background:
People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI.
Objective:
To see if GHRH can improve sleep in people who have had a TBI.
Eligibility:
Active duty
Study InterventionsTesamorelin, PlaceboPrimary EndpointsChange in NREM time following tesamorelin administration compared to placeboStudy Period2016-10-06 → 2017-03-08 Effect of DPP4 Inhibition on Growth Hormone Secretion
This study tests the following hypotheses:
Aim 1: Test the hypothesis that acute dipeptidyl peptidase 4 (DPP4) inhibition with the currently available anti-diabetic drug, sitagliptin, will increase stimulated growth hormone (GH) secretion in healthy lean adults by decreasing the degradation of growth hormone releasing hormone (GHRH).
Aim 2: Test the hypothesis that decreased degradation of GHRH
Study InterventionsSitagliptin, Pegvisomant, PlaceboPrimary EndpointsAim 1: Stimulated Peak Growth Hormone Level; Aim 1: Percent Change From Baseline in Forearm Vascular ResistanceStudy Period2013-01 → 2017-05 Body Composition and Adipose Tissue in HIV
In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate m
Study InterventionsTesamorelinPrimary EndpointsChange in Hepatic Lipid ContentStudy Period2018-02-07 → 2025-04-30 Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in d
Study InterventionsTesamorelin, Placebo, ExercisePrimary EndpointsChange in Repeated Chair Stand TimeStudy Period2025-07-07 → 2028-12-01 Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly.
II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH hypersecretion.
A Two Part Phase 1, Repeated Doses and Continuous Infusion Study With ITF2984 in Healthy Volunteers
The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14 consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label, continuous subcutaneous infusion for 7 days
Study InterventionsITF2984 (100, 2000, 3000 mcg bid), PlaceboPrimary EndpointsTo investigate the safety profile of repeated doses of ITF2984; To investigate the pharmacokinetics (PK) profile of multiple ascending doses of ITF2984Study Period2013-05 → 2013-12 Estradiol-Receptor Blockade in Older Men and Women
Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER). Conversely, we postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a
Study InterventionsToremifene, Placebo, GHRH/Ghrelin combined InjectionPrimary EndpointsSummed mass of growth hormone over 10 hoursStudy Period2014-12 → 2016-05 Dehydroepiandrosterone Versus Growth Hormone in Women Undergoing ICSI With Expected Poor Ovarian Response
300 women with expected poor ovarian response (POR) undergoing in vitro fertilization or intra-cytoplasmic sperm injection (ICSI) will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Dehydroepiandrosterone (DHEA) 25 mg ( DHEA 25mg, Natrol , USA) t.d.s daily for 12 weeks before starting IVF/ICSI cycle and a placebo similar to growth hormone (GH)
Study InterventionsDHEA, Growth Hormone-Releasing Hormone, Placebo 1Primary EndpointsOngoing pregnancyStudy Period2016-06 Egrifta Replacement and Sleep Disordered Breathing
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 fo
Study InterventionsTesamorelin (Egrifta)Primary EndpointsChanges in Sleep Apnea Severity; Changes in Sleep Apnea SeverityStudy Period2012-05