Somatropin (HGH) news and clinical trials

Changchun GeneScience Pharmaceutical Co., Ltd. registered a Phase 3 clinical trial to evaluate the efficacy and safety of once-weekly PEG-hGH injection compared to once-daily hGH injection in 105 children with short stature due to small for gestational age.

A meta-analysis of 30 studies comprising 3,287 patients found that once-weekly long-acting growth hormone has comparable efficacy and safety to daily growth hormone in children with short stature. The study noted that long-acting versions may improve treatment convenience and adherence.

Zhongshan Sansure Hygene Biomedicine Co., Ltd. registered a Phase 3 clinical trial to evaluate the efficacy and safety of daily human growth hormone injection, Sinotropin AQ, in 240 pediatric participants with idiopathic short stature.

A systematic review of 10 studies found that growth hormone deficiency is linked to specific patterns of craniofacial underdevelopment and delayed dentofacial maturation. Researchers concluded that growth hormone therapy may partially normalize several of these craniofacial parameters.

The University of Calgary registered an observational study involving 200 participants to characterize the impact of growth hormone deficiency on quality of life and sleep in adults with traumatic brain injury.

Researchers conducted a Phase 1 study of ALXN2420, a 16-amino acid peptide growth hormone receptor antagonist, in 101 healthy subjects. The study found the treatment was well tolerated at doses up to 120 mg per day and successfully decreased insulin-like growth factor-1 levels.

Alexion Pharmaceuticals terminated its phase 2 study of ALXN2420 in combination with somatostatin analogs for acromegaly. The company cited strategic portfolio prioritization as the reason for the decision.

New review in Endocrinology, diabetes & metabolism: Long-Acting Growth Hormone Versus Daily Growth Hormone for Growth Hormone Deficiency Patients: A Network Meta-Analysis of Clinical Trials.

Pfizer completed a phase 1 study evaluating the bioequivalence of two different injector pens used to administer Genotropin (somatropin). The study involved 27 healthy adult participants.

New randomized trial in Journal of clinical neuroscience : official journal of the Neurosurgical…: Phase III Open-Label, Randomized Clinical Trial of Epidermal Growth Factor and Growth Hormone Releasing Hexapeptide in Acute Ischemic Stroke.

Changchun GeneScience Pharmaceutical is recruiting for a phase 4 trial evaluating the safety and efficacy of recombinant human growth hormone injection in 100 adults with short bowel syndrome.

Researchers performed a secondary analysis of two human laboratory studies on the effect of the growth hormone secretagogue receptor inhibitor PF-5190457 on alcohol craving. The study found that PF-5190457 reduced self-reported alcohol craving in high-craving individuals after a cue-exposure trial.

Lumos Pharma completed a phase 2 trial of daily oral LUM-201 in 104 prepubertal children with idiopathic growth hormone deficiency. The study investigated LUM-201 as a treatment and assessed a predictive enrichment marker strategy to select likely responders.

A systematic review of 28 articles examined the impact of growth hormone therapy on brain function in patients with dementia, traumatic brain injury, and stroke. The authors found that growth hormone therapy shows potential for memory and brain recovery, though consistent data remains lacking.

Changchun GeneScience Pharmaceutical Co., Ltd. terminated a phase 2 trial comparing the GS3-007a growth hormone stimulation test to the insulin tolerance test for diagnosing adult growth hormone deficiency due to an adjustment in product development strategy.

A systematic review of single nucleotide polymorphisms in goat genes concluded that IGF-1 gene markers can aid in the genetic improvement of body weight and chest width, while growth hormone gene markers can assist with body weight, withers height, heart girth, and body length.

The University of Missouri-Columbia registered an observational study to examine how beta-cells respond to growth hormone in people with impaired fasting glucose or impaired glucose tolerance. The study aims to recruit 10 participants.

Enhanced Emirates Limited registered a hybrid study of 60 elite athletes to assess the safety and tolerability of various performance-enhancing substances. The study involves a 25-week exposure period and a 5-year follow-up.

New meta-analysis in Endocrine: Once-weekly somapacitan vs. daily norditropin in GHD: a systematic review and meta-analysis of efficacy and safety in children and adults.

Kexing Biopharm Co., Ltd. registered a phase 3 trial to compare the efficacy and safety of its human growth hormone injection GB06 against Norditropin FlexPro in 192 children with growth hormone deficiency. Participants will receive treatment for 52 weeks.

Xiamen Amoytop Biotech is recruiting participants for a phase 2a trial evaluating the safety, pharmacokinetics, and efficacy of inpegsomatropin injection in 36 adults with growth hormone deficiency.

Pfizer registered a phase 1 study to compare the delivery and blood uptake of Genotropin (somatropin) administered via two different injector pens. The study enrolled 27 healthy adults to evaluate bioequivalence.

New meta-analysis in European journal of pediatrics: The impact of growth hormone therapy on ocular structural parameters in idiopathic short stature: a systematic review and meta-analysis.

Lumos Pharma completed a phase 2 study evaluating the growth and safety of LUM-201 in 15 children with idiopathic growth hormone deficiency who had previously received 12 months of rhGH treatment.

A systematic review and meta-analysis of 5 studies compared Jintrolong with other growth hormone treatments in East Asian children. Jintrolong showed more favorable height velocity and growth responses over 52 weeks compared to daily growth hormone and other long-acting therapies.

Assistance Publique - Hôpitaux de Paris terminated this phase 4 trial, which compared two recombinant human growth hormone regimens in 10 children born small for gestational age, because there were no more inclusions.

A phase 3 clinical trial of 198 adults with growth hormone deficiency found that once-weekly somatrogon did not significantly improve trunk fat mass compared to placebo after 26 weeks. However, the treatment significantly improved lean body mass and was generally well tolerated.

Anhui Provincial Hospital registered a Phase 4 trial of recombinant human growth hormone in 160 elderly patients with moderate to severe acute brain injury and hypoalbuminemia to evaluate its safety and effectiveness.

A meta-analysis of 585 patients compared body mass index changes between long-acting growth hormone and daily growth hormone in children with deficiency. The study found an increase in body mass index standard deviation score is associated with the first year of long-acting growth hormone use.

Changchun GeneScience Pharmaceutical Co., Ltd. registered a Phase 1/2 trial of GenSci134 in 128 children with pediatric growth hormone deficiency. The research evaluates the safety and efficacy of GenSci134 compared to Norditropin® FlexPro®.

Changchun GeneScience Pharmaceutical Co., Ltd. registered a Phase 1/2 trial of GenSci134 in 128 children with idiopathic short stature. The study compares the safety and efficacy of GenSci134 against Norditropin® FlexPro®.

Cliniques universitaires Saint-Luc completed a study surveying 500 patients on their propensity to switch from daily recombinant human growth hormone to long-acting growth hormone analogues. The study addressed the burden of daily injections and the development of new weekly or monthly options.

Researchers published a protocol for a pilot randomized trial evaluating rHGH at a dose of 0.5 mg per body surface area (0.5 mg/m 2) alongside physical therapy for knee osteoarthritis. The study will recruit 17 participants per arm to assess feasibility and safety.

The University of Aarhus registered a study with 10 adults to investigate how ketone bodies and growth hormone affect insulin sensitivity. Researchers are using PET/CT imaging and tissue biopsies to measure energy metabolism.

A systematic review of 22 studies with 1,157 patients found rHGH at a mean dose of 1.49 mg/d increased lean body mass and leg extension strength. The review noted side effects including peripheral edema (OR = 3.03) and carpal tunnel symptoms (OR = 3.85).

Novo Nordisk A/S posted results for a Phase 2 trial involving 76 pre-pubertal children with growth hormone deficiency. The trial compared the efficacy and safety of once-weekly somapacitan treatment against daily Norditropin® FlexPro® injections.

Assistance Publique - Hôpitaux de Paris registered an observational trial for 200 children with isolated non-acquired growth hormone deficiency. The study will assess body composition changes during treatment with growth hormone.

New meta-analysis in Eye (London, England): Growth hormone therapy and ocular biometry in paediatric growth hormone deficiency: a systematic review and meta-analysis.

Ascendis Pharma Endocrinology Division completed a phase 3 open-label extension study of once-weekly lonapegsomatropin in 220 adults with growth hormone deficiency. The study assessed long-term efficacy and safety.

Beni-Suef University registered a Phase 2/3 trial of 165 patients to compare the effects of Somatropin and DHEA on poor ovarian reserve during in vitro fertilization. The study aims to determine which intervention is more effective for increasing follicle count and size.

A randomized controlled study found that the growth hormone secretagogue receptor blocker PF-5190457 effectively reduced growth hormone levels in patients with alcohol use disorder. Despite these changes, the drug produced negligible effects on other endocrine and immune system markers.

Xiamen Amoytop Biotech Co., Ltd. registered a phase 3 trial to evaluate the efficacy and safety of inpegsomatropin injection compared to recombinant human growth hormone in 141 children born small for gestational age.

The multicenter foresiGHt trial evaluated the efficacy and safety of once-weekly lonapegsomatropin versus placebo in 259 adults with growth hormone deficiency. Lonapegsomatropin significantly reduced trunk fat and increased lean body mass compared to placebo over 38 weeks.

Changchun GeneScience Pharmaceutical completed a phase 4 clinical study evaluating the efficacy and safety of recombinant human growth hormone in 39 children with achondroplasia.

Novo Nordisk A/S terminated an observational study involving 43 children with idiopathic short stature. The sponsor stopped the study due to recruitment challenges.

A study assessing the pharmacokinetics and pharmacodynamics of YPEG-rhGH in 16 healthy elderly subjects established a model to predict insulin-like growth factor-1 response. The researchers concluded that the drug was safe and well tolerated in this population.

Changchun GeneScience Pharmaceutical Co., Ltd. registered a phase 1b/2 clinical trial involving 88 children to evaluate the safety and efficacy of an oral growth hormone treatment, GS3-007a dry suspension. The study includes a 14-day dose-finding phase followed by a 52-week treatment comparison.

Changchun GeneScience Pharmaceutical Co., Ltd. is recruiting 72 children born small for gestational age for a Phase 2 trial. The study evaluates the efficacy, safety, and pharmacokinetics of PEG-rhGH injection compared to hGH injection.

The University of Massachusetts, Worcester terminated a Phase 1 study of Nutropin AQ for cystic fibrosis-related wasting. The study stopped because of poor enrollment and patients lost to follow up.

New meta-analysis in Growth hormone & IGF research : official journal of the Growth Hormone…: Safety and efficacy of somapacitan in adults with growth hormone deficiency who were switched from daily growth hormone therapy: A systematic review and meta-analysis.

Researchers conducted a meta-analysis of 41 studies on growth hormone therapy in Prader-Willi syndrome patients. The study found that growth hormone therapy significantly improved height and insulin-like growth factor 1 levels, while reducing body mass index compared to untreated patients.

A 4-year phase 3 study of Japanese children with growth hormone deficiency showed that once-weekly somatrogon treatment resulted in improved height velocity and was well tolerated. The study included patients who transitioned to somatrogon from once-daily somatropin therapy.