🧪 TrialInsufficient
Registered Phase 1 interventional trial (withdrawn). The purpose of this study is to determine whether the intravenous administration of single- and multiple-ascending doses of Thymosin Beta 4 is safe and tolerable in healthy volunteers.
ClinicalTrials.gov · Aug 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 4 interventional trial (terminated), with sponsor-posted results. This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.
ClinicalTrials.gov · Jul 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Obesity, a condition that occurs when a person has too much body fat, affects about 31% of people in the United States. It is associated with increased risk of diabetes, high blood pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is also associated with low levels of growth hormone, a hormone that affects rate of growth and the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that makes the body naturally increase its own growth hormone leve
ClinicalTrials.gov · May 2008View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (completed). The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.
ClinicalTrials.gov · May 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
ClinicalTrials.gov · Feb 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific to this population. Within the ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment. Although DR can be addressed surgically, surgery remains a less than ideal intervention within this population with a well-characterized compromised ability to heal.
ClinicalTrials.gov · Jan 2008View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (terminated). This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo. The objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.
ClinicalTrials.gov · Dec 2005View trial ↗ Animal only
This animal study investigated how human growth hormone (hGH) and a synthetic lipolytic fragment derived from its C-terminus, AOD9604, affect fat metabolism and body weight in obese and genetically modified mice. Obese mice received 14 days of chronic intraperitoneal administration of either compound. Both hGH and AOD9604 reduced body weight and body fat in obese mice, and these effects were associated with increased expression of beta-3 adrenergic receptor (β3-AR) RNA — a key receptor involved in fat breakdown — bringing levels in obese mice closer to those seen in lean mice. To test whether β3-AR was essential to these effects, the researchers used β3-AR knock-out mice; in these animals, chronic treatment with either compound failed to produce the body weight reduction or increased lipolysis seen in normal mice. However, in an acute experiment, AOD9604 still increased energy expenditure and fat oxidation in knock-out mice, suggesting additional mechanisms exist. The authors concluded that while neither compound acts directly through β3-AR, both upregulate its expression, which may amplify lipolytic sensitivity over time. Key limitations include the exclusively animal-based design and the use of intraperitoneal administration, limiting direct translation to humans.
Endocrinology · Dec 2001DOI ↗ Animal only
This study compared the pharmacokinetics of five peptidyl growth hormone secretagogues — ipamorelin (NNC 26-0161), NNC 26-0194, NNC 26-0235, GHRP-2, and GHRP-6 — in male rats using multiple routes of administration, with a particular focus on nasal delivery. Following intravenous bolus injection, all peptides showed biexponential plasma concentration decline. Ipamorelin stood out with a systemic plasma clearance approximately five times lower than GHRP-6. Excretion routes differed: ipamorelin was primarily cleared via urine, while GHRP-6 and the two NNC peptides were predominantly excreted in bile. Metabolic stability was moderate for ipamorelin and the NNC peptides, with 60–80% of administered doses recoverable as intact peptide from bile and urine combined. Intranasal bioavailability of ipamorelin was estimated at approximately 20%, while NNC 26-0235, NNC 26-0194, and GHRP-2 achieved approximately 50% nasal bioavailability. The authors concluded that nasal delivery appears to be a promising route for this peptide class. Key limitations include exclusive use of animal subjects (male rats), meaning findings may not directly translate to humans, and the study did not assess pharmacodynamic or safety endpoints.
Xenobiotica; the fate of foreign compounds in biological systems · Nov 1998DOI ↗