A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Follicle-stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection in Idiopathic Hypogonadotropin Hypogonadism

This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Start Date20 Sep 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

CTR20243077

/ RecruitingPhase 3

一项在14至18岁青少年男性特发性低促性腺激素性性腺功能减退症（IHH）中评估重组人促卵泡激素-CTP融合蛋白注射液（rhFSH-CTP）或安慰剂联合注射用绒促性素（hCG）启动或恢复青春期的疗效和安全性的多中心、随机双盲、III期临床研究

[Translation] A multicenter, randomized, double-blind, phase III clinical study to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone-CTP fusion protein injection (rhFSH-CTP) or placebo combined with injectable chorionic gonadotropin (hCG) in initiating or resuming puberty in adolescent males aged 14 to 18 years with idiopathic hypogonadotropic hypogonadism (IHH)

主要目的是在中国14至18岁青少年男性IHH中评估GenSci094联合hCG给药启动或恢复青春期的疗效；次要目的是评估GenSci094联合hCG给药在除睾丸体积外其他青春期启动或恢复方面的疗效，评估GenSci094的药代动力学（PK）特征、安全性、免疫原性。

[Translation]

The primary objective is to evaluate the efficacy of GenSci094 combined with hCG administration in initiating or resuming puberty in Chinese adolescent males aged 14 to 18 years with IHH; the secondary objective is to evaluate the efficacy of GenSci094 combined with hCG administration in other aspects of puberty initiation or resuming except testicular volume, and to evaluate the pharmacokinetic (PK) characteristics, safety, and immunogenicity of GenSci094.

Start Date11 Sep 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

NCT05896293

/ RecruitingPhase 2IIT

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.
Funding Source: FDA OOPD

Start Date03 Feb 2023

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

100 Clinical Results associated with Idiopathic Hypogonadotropic Hypogonadism

100 Translational Medicine associated with Idiopathic Hypogonadotropic Hypogonadism

0 Patents (Medical) associated with Idiopathic Hypogonadotropic Hypogonadism

851

Literatures (Medical) associated with Idiopathic Hypogonadotropic Hypogonadism

01 Feb 2025·Molecular Metabolism

Intrahepatic levels of microbiome-derived hippurate associates with improved metabolic dysfunction-associated steatotic liver disease

Article

Author: Pacheco-Tapia, Romina ; Dumas, Marc-Emmanuel ; Lassailly, Guillaume ; Andrikopoulos, Petros ; Toussaint, Bénédicte ; Oger, Frédérik ; Staels, Bart ; Derhourhi, Mehdi ; Froguel, Philippe ; Bonnefond, Amélie ; Kahoul, Yasmina ; Gambardella, Nicolas ; Caiazzo, Robert ; Raverdy, Violeta ; Amanzougarene, Souhila ; Zaïbi, Nawel ; Puig-Castellvi, Francesc ; Lefebvre, Philippe ; Deslande, Maxime ; Pattou, François ; Leloire, Audrey ; Castro-Dionicio, Inés

OBJECTIVEMetabolic dysfunction-associated steatotic liver disease (MASLD) is characterised by lipid accumulation in the liver and is often associated with obesity and type 2 diabetes. The gut microbiome recently emerged as a significant player in liver metabolism and health. Hippurate, a host-microbial co-metabolite has been associated with human gut microbial gene richness and with metabolic health. However, its role on liver metabolism and homeostasis is poorly understood.METHODSWe characterised liver biospies from 318 patients with obesity using RNAseq and metabolomics in liver and plasma to derive associations among hepatic hippurate, hepatic gene expression and MASLD and phenotypes. To test a potential beneficial role for hippurate in hepatic insulin resistance, we profile the metabolome of (IHH) using ultra-high-performance liquid chromatography coupled to high-resolution tandem mass spectrometry (UHPLC-MS/MS), and characterised intracellular triglyceride accumulation and glucose internalisation after a 24 h insulin exposure.RESULTSWe first report significant associations among MASLD traits, plasma and hepatic hippurate. Further analysis of the hepatic transcriptome shows that liver and plasma hippurate are inversely associated with MASLD, implicating lipid metabolism and regulation of inflammatory responses pathways. Hippurate treatment inhibits lipid accumulation and rescues insulin resistance induced by 24-hour chronic insulin in IHH. Hippurate also improves hepatocyte metabolic profiles by increasing the abundance of metabolites involved in energy homeostasis that are depleted by chronic insulin treatment while decreasing those involved in inflammation.CONCLUSIONSAltogether, our results further highlight hippurate as a mechanistic marker of metabolic health, by its ability to improve metabolic homeostasis as a postbiotic candidate.

24 Dec 2024·Endocrine Connections

Magnetic resonance imaging does not distinguish Kallmann syndrome from normosmic isolated hypogonadotropic hypogonadism

Article

Author: Rabijewski, Michał ; Ziemnicka, Katarzyna ; Kałużny, Jarosław ; Katulska, Katarzyna ; Budny, Bartłomiej ; Moczko, Jerzy ; Kałużna, Małgorzata ; Kompf, Pola ; Komarnicki, Paweł ; Ruchała, Marek

Introduction and objectivesIsolated hypogonadotropic hypogonadism (IHH) may be associated with pituitary gland and olfactory system disorders. We aimed to correlate findings of magnetic resonance imaging (MRI) of the pituitary gland and olfactory system in IHH patients with the patients’ olfactory phenotype.Patients and methodsThe present research was a single-center retrospective case–control study. MRI patterns of the pituitary gland and olfactory system were studied in 46 patients, of whom 29 (63%) were classified on the basis of olfactometry as having Kallmann syndrome (KS) (16 patients with anosmia and 13 patients with hyposmia) and 17 (37%) as having normosmic IHH (nIHH). Results were compared with age- and sex-matched healthy controls. Genetic diagnosis was conducted in all IHH patients based on next-generation sequencing.ResultsAlmost 70% prevalence of pituitary hypoplasia was observed in IHH subjects. Olfactory bulb (OB) abnormalities were identified in 80.4% of all patients, both the KS (82.8%) and the nIHH (76.5%) subjects. Incidence of unilaterally abnormal, hypoplastic olfactory sulcus (OS) was equally frequent in nIHH and KS. Statistically, piriform cortical thickness was significantly lower in all patient groups than in controls.ConclusionsMRI cannot exclusively differentiate between KS and nIHH, as both conditions may present with OB and OS abnormalities. A surprisingly high frequency of olfactory system abnormalities was observed in nIHH patients, while anterior pituitary hypoplasia was prevalent across all IHH patients. Notably, OB abnormalities were more predominant in KS patients than in those with nIHH.

18 Dec 2024·The Journal of Clinical Endocrinology & Metabolism

Contributions of Common Genetic Variants to Constitutional Delay of Puberty and Idiopathic Hypogonadotropic Hypogonadism

Article

Author: Mericq, Verónica ; Hirschhorn, Joel N ; Delaney, Angela ; Hindman, Anna A ; Grinspon, Romina ; McElreavey, Kenneth ; Giannakopoulos, Aristeides ; Hall, Janet E ; de Lima Jorge, Alexander A ; Brauner, Raja ; Schafer, Evan C ; Dunkel, Leo ; Merino, Paulina ; Lippincott, Margaret F ; He, Wen ; Howard, Sasha R ; Seminara, Stephanie B ; Rezende, Raíssa Carneiro ; Palmert, Mark R ; Salem, Rany M ; Chan, Yee-Ming ; Latronico, Ana Claudia ; Rey, Rodolfo

AbstractContextConstitutional delay of puberty (CDP) is highly heritable, but the genetic basis for CDP is largely unknown. Idiopathic hypogonadotropic hypogonadism (IHH) can be caused by rare genetic variants, but in about half of cases, no rare-variant cause is found.ObjectiveTo determine whether common genetic variants that influence pubertal timing contribute to CDP and IHH.DesignCase-control study.Participants80 individuals with CDP; 301 with normosmic IHH, and 348 with Kallmann syndrome (KS); control genotyping data from unrelated studies.Main Outcome MeasuresPolygenic scores (PGS) based on genome-wide association studies for timing of male pubertal hallmarks and age at menarche (AAM).ResultsThe CDP cohort had higher PGS for male pubertal hallmarks and for AAM compared to controls (for male hallmarks, Cohen's d = 0.67, P = 1 × 10−10; for AAM, d = 0.85, P = 1 × 10−16). The normosmic IHH cohort also had higher PGS for male hallmarks compared to controls, but the difference was smaller (male hallmarks d = 0.20, P = .003; AAM d = 0.10, P = .055). No differences were seen for the KS cohort compared to controls (male hallmarks d = 0.05, P = .45; AAM d = 0.03, P = .56).ConclusionCommon genetic variants that influence pubertal timing in the general population contribute strongly to the genetics of CDP, weakly to normosmic IHH, and potentially not at all to KS. These findings demonstrate that the common-variant genetics of CDP and normosmic IHH are largely but not entirely distinct.

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