Limited · human
This study developed and validated an analytical method for detecting a broad panel of 18 performance-enhancing peptides (molecular weight <2 kDa) in human urine, as defined by the World Anti-Doping Agency (WADA) prohibited list. The method uses direct urine injection—bypassing complex sample preparation—coupled with liquid chromatography and ion mobility time-of-flight mass spectrometry (IM-TOFMS). The researchers reported limits of detection (LOD) ranging from 50 to 500 pg/mL, well below WADA's minimum required performance level of 2 ng/mL. The method demonstrated acceptable precision (imprecision <20%) and linearity across a 0–10 ng/mL working range. Stability testing identified –20°C as the appropriate storage temperature for urine samples. As a proof-of-concept, the method was applied to real elimination study urine samples from individuals who had administered GHRP-2, GHRP-6, or LHRH, successfully detecting these compounds. Key limitations include the small number of human subjects used in the elimination studies, which were primarily intended to demonstrate analytical feasibility rather than investigate pharmacokinetics or clinical effects. The study is a methodological/analytical validation paper focused on anti-doping screening, not a clinical or therapeutic investigation.
Journal of separation science · Dec 2015DOI ↗ 🧪 TrialInsufficient
Registered Phase 2/Phase 3 interventional trial (completed). The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
ClinicalTrials.gov · Nov 2015View trial ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls.
ClinicalTrials.gov · Sep 2015View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
ClinicalTrials.gov · Jan 2015View trial ↗ 🧪 TrialLimited · human
Registered Phase 3 interventional trial (completed), with sponsor-posted results. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.
ClinicalTrials.gov · Jan 2015View trial ↗ Animal only
This study investigated the effects of intra-articular injections of AOD9604 (a synthetic peptide fragment of human growth hormone) alone and in combination with hyaluronic acid (HA) in a collagenase-induced knee osteoarthritis (OA) rabbit model. Thirty-two mature New Zealand white rabbits had OA induced in both knees via collagenase injection, then were divided into four groups receiving weekly intra-articular injections of saline, HA alone, AOD9604 alone, or AOD9604 combined with HA. At eight weeks, outcomes were assessed via gross morphology, histopathology of cartilage, and lameness scoring. The study found that all treatment groups showed significantly less cartilage degeneration than the saline control group. The combination of AOD9604 and HA produced significantly lower cartilage damage scores and shorter lameness periods compared to either treatment alone. While these findings suggest a potential chondroprotective and synergistic effect, the study is limited by its animal-only design, relatively small group sizes, and the use of a chemically induced OA model that may not fully replicate human OA pathology. No human data were collected, so translation of findings to clinical practice remains uncertain.
Annals of clinical and laboratory science · Jan 2015Source ↗ Review
This review paper surveys the current landscape of analytical methods used in sports anti-doping laboratories to detect peptide-based drugs, drug candidates, and their analogs in biological specimens such as blood, serum, and urine. The authors describe the broad range of peptidic compounds subject to anti-doping scrutiny, spanning low-molecular-mass peptides (e.g., growth hormone-releasing peptides, ARA-290, TB-500, AOD-9604, CJC-1295, desmopressin) to intermediate-mass proteins (e.g., insulins, IGF-1, growth hormone, erythropoietin) and higher-molecular-mass biologics (e.g., stamulumab). The review outlines detection approaches including chromatographic-mass spectrometric, electrophoretic, immunological, and combined methodologies, emphasizing the challenge of proving exogenous origin at very low concentrations in limited sample volumes. A central finding is that a meaningful gap remains between what is technically achievable in detection and what is routinely practiced in day-to-day analytical workflows. Limitations of this paper include its nature as a narrative review rather than an original experimental study, meaning it synthesizes existing literature without generating new empirical data. It does not evaluate clinical outcomes or therapeutic efficacy of any compound discussed.
Expert review of proteomics · Nov 2014DOI ↗ 🧪 TrialInsufficient
Registered Phase 1 interventional trial (completed). 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 new estrogen antagonist used adjunctively in prostatic cancer
ClinicalTrials.gov · Oct 2014View trial ↗ In vitro
This study focused on developing analytical methods to detect AOD9604 — a synthetic peptide derived from the C-terminal fragment (residues 177–191) of human growth hormone with an added N-terminal tyrosine — in biological samples for anti-doping purposes. AOD9604 is reported to mimic the lipolytic effects of growth hormone without diabetogenic side effects, making it a candidate performance-enhancing drug banned by WADA. Researchers validated a solid-phase extraction method for detecting AOD9604 in urine, achieving a limit of detection of 50 pg/mL with acceptable linearity, precision (below 20%), specificity, and recovery (62%). The study also characterized in vitro metabolism by incubating AOD9604 in serum and urine, identifying six potential metabolites. Quantification in serum revealed one notably stable metabolite — a peptide fragment consisting of the amino acid sequence CRSVEGSCG — that persisted longer than both the parent compound and other metabolites. The authors suggest that screening for both AOD9604 and this stable metabolite could extend the detection window in doping controls. Limitations include the in vitro nature of the metabolic data, meaning real-world metabolic behavior in human subjects in vivo remains uncharacterized.
Drug testing and analysis · Sep 2014DOI ↗ 🧪 TrialLimited · human
Registered N/A interventional trial (completed), with sponsor-posted results. 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 w
ClinicalTrials.gov · Jul 2014View trial ↗ Review
This review summarizes five years of published literature on the analytical detection of emerging and non-approved performance-enhancing substances in the context of sports anti-doping controls. The authors examine a broad range of compounds classified as doping agents by the World Anti-Doping Agency (WADA), spanning both peptidic substances—such as modified insulin-like growth factor-1 (IGF-1), TB-500 (thymosin beta-4 fragment), peginesatide/hematide, growth hormone releasing peptides, and AOD-9604—and non-peptidic substances, including selective androgen receptor modulators (SARMs), hypoxia-inducible factor (HIF) stabilizers, siRNA, S-107, and aladorian (ARM036). Inorganic substances such as cobalt are also discussed. The review focuses specifically on the analytical challenges posed by these compounds, including their physicochemical properties, low concentrations in biological matrices (blood and urine), metabolic transformation, and suitability for chromatographic–mass spectrometric or alternative detection methods. The study does not present original experimental data or human clinical outcomes, but rather synthesizes existing literature to guide development of detection strategies. A key limitation is that, as a review, it does not independently validate any analytical method and reflects the state of the field only up to its publication date.
Journal of pharmaceutical and biomedical analysis · May 2014DOI ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age
ClinicalTrials.gov · Aug 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant
ClinicalTrials.gov · Jul 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye
ClinicalTrials.gov · Jul 2011View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.
ClinicalTrials.gov · Jun 2011View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (withdrawn). The objective of this study is to evaluate the safety and tolerability of two active doses of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial infarction receiving percutaneous coronary intervention angioplasty with or without stent placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 more weeks.
ClinicalTrials.gov · Mar 2011View trial ↗ 🧪 TrialInsufficient
Registered Phase 2 interventional trial (completed). Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
ClinicalTrials.gov · Jan 2011View trial ↗ 🧪 TrialLimited · human
Registered N/A interventional trial (completed), with sponsor-posted results. HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly
ClinicalTrials.gov · Dec 2010View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (terminated), with sponsor-posted results. The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the t
ClinicalTrials.gov · Dec 2008View trial ↗ 🧪 TrialLimited · human
Registered Phase 2 interventional trial (completed), with sponsor-posted results. PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its
ClinicalTrials.gov · Nov 2008View trial ↗