Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia.
The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin.
The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia.
The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia.

Start Date01 Mar 2024

Sponsor / Collaborator

Universitätsspital Basel

NCT03449251 / Active, not recruitingPhase 2IIT

A Series of Pilot Studies to Evaluate the Haemodynamic and Metabolic Effects of Apelin and Relaxin in Healthy Humans, Subjects With Increased Weight and Patients With Type 2 Diabetes Mellitus

Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased by being overweight and also through a sedentary lifestyle. As the onset can be gradual, physiological damage may have occurred prior to diagnosis. Diabetes is associated with the development of microvascular complications (diabetic nephropathy, neuropathy, and retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial disease, and stroke). While there are many treatments available for T2DM, these complications may still arise, leading to significant morbidity and mortality. There is therefore an urgent need to identify novel signalling pathways that may contribute to the development of diabetes related complications. The identification of these pathways may ultimately lead to the development of new therapies targeting better blood glucose control and preventing these subsequent complications.
Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin both act as vasodilators in the human cardiovascular system and could also have beneficial action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this hypothesis, and explore the signalling pathway in the human vascular system.

Start Date28 Mar 2018

Sponsor / Collaborator

Cambridge University Hospitals NHS Foundation Trust

[+3]

NCT02724566 / CompletedPhase 1IIT

Influence of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers

Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.

Start Date01 May 2016

Sponsor / Collaborator

Société Francophone Du Diabete

100 Clinical Results associated with Apelin

100 Translational Medicine associated with Apelin

100 Patents (Medical) associated with Apelin

974

Literatures (Medical) associated with Apelin

01 Dec 2024·Theriogenology

Expression of the apelin system in the porcine pituitary during the oestrous cycle and early pregnancy and the effect of apelin on LH and FSH secretion

Article

Author: Dobrzyn, Kamil ; Zaobidna, Ewa ; Kiezun, Marta ; Smolinska, Nina ; Kaminski, Tadeusz ; Kopij, Grzegorz ; Gudelska, Marlena ; Rytelewska, Edyta ; Kisielewska, Katarzyna ; Wasilewska, Barbara

Reproductive success requires considerable energy investment. Research has shown that some adipokines, i.e. the hormones produced in adipose tissue, affect reproductive functions by influencing all structures of the hypothalamic-pituitary-ovarian axis. Apelin is a recently identified member of the adipokine family. To the best of the authors' knowledge, this is the first study to investigate the gene and protein expression of the apelin system (the apelin hormone and the apelin receptor, APJ) in the anterior (AP) and posterior (PP) pituitary lobes of the domestic pig during different phases of the oestrous cycle (days 2 to 3, 10 to 12, 14 to 16, and 17 to 19) and in early pregnancy (days 10 to 11, 12 to 13, 15 to 16, and 27 to 28). It was also assumed that apelin participates in the regulation of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion and influences Akt, MAPK/Erk1/2, and AMPK signalling pathways in the AP during the oestrous cycle. Apelin, APJ mRNAs and proteins were detected in both pituitary lobes. Apelin was identified in gonadotropes, somatotropes, lactotropes, and thyrotropes. The study also revealed that apelin and APJ mRNA/protein levels fluctuate during the oestrous cycle and early gestation. Apelin affects basal, GnRH- and/or insulin-stimulated gonadotropin secretion in some phases of the cycle, as well as the phosphorylation of Akt, MAPK/Erk1/2, and AMPK proteins in AP cells. These findings suggest that apelin may be produced locally in the pituitary and that this gland is receptive to apelin's action. The study also suggest that apelin may influence female reproductive functions by controlling the release of LH and FSH from AP cells, and that it affects Akt, MAPK/Erk1/2, and AMPK signalling pathways.

01 Dec 2024·Molecular Biology Reports

Quercetin prevents kidney against diabetes mellitus (type 1) in rats by inhibiting TGF-β/apelin gene expression

Article

Author: Firouzeh, Gholampour ; Zeinab, Karimi ; Gholamreza, Daryabor ; Hossein, Ashraf

BACKGROUNDOne of the main causes of diabetic nephropathy is oxidative stress induced by hyperglycemia. Apelin inhibits insulin secretion. Besides, renal expression of TGF-β is increased in diabetes mellitus (DM). The preventive effect of quercetin (Q) against renal functional disorders and tissue damage developed by DM in rats was assessed.METHODSForty male Wistar rats were grouped into normal control (NC), normal + quercetin (NQ: quercetin, 50 mg/kg/day by gavage), diabetic control (DC: streptozotocin, 65 mg/kg, i.p.), diabetic + quercetin pretreatment (D + Qpre), and diabetic + quercetin post-treatment (D + Qpost). All samples (24-hour urine, plasma, pancreatic, and renal tissues) were obtained at the terminal of the experiment.RESULTSCompared to NC and NQ groups, DM ended in elevated plasma and glucose levels, decreased plasma insulin level, kidney dysfunction, augmented levels of malondialdehyde, decreased level of reduced glutathione, reduced enzymatic activities of superoxide dismutase and catalase, elevated gene expression levels of apelin and TGF-β, also renal and pancreatic histological damages. Quercetin administration diminished entire the changes. However, the measure of improvement in the D + Qpre group was higher than that of the D + Qpost group.CONCLUSIONQuercetin prevents renal dysfunction induced by DM, which might be related to the diminution of lipid peroxidation, strengthening of antioxidant systems, and prevention of the apelin/ TGF-β signaling pathway.

01 Nov 2024·Neuroscience Letters

Effects of Apelin-13 on auditory system in STZ-induced diabetic rats

Article

Author: Kılınç, Sevtap ; Eylül Aydemir, Berfin ; Arzu Yiğit, Ayşe ; Güneşer, Özgecan ; Ölçüoğlu, Rukiye ; Kilinç, Sevtap

AIMDamage to the auditory pathways is one of the complications of diabetes. The aim of this study was to investigate the potential therapeutic effects of apelin-13 in the auditory pathways of rats with experimentally induced diabetes by examining its effect on auditory brainstem responses, cochlear oxidative stress and inflammatory cytokines.METHODSThirty-two male Wistar albino rats were divided into four groups: sham control, diabetes, apelin and diabetes + apelin. A single dose of 45 mg/kg streptozotocin (STZ) was administered to induce diabetes. The apelin group received 50 µg/kg apelin-13 for seven days intraperitoneally (ip). At the end of the apelin and STZ applications auditory brainstem responses (ABR) was recorded. At the end of the experiment, cochlea was removed and biochemical analyzes were performed.RESULTSIn ABR recordings, the latencies of wave V in diabetic group were observed to be longer than those of the control, with the apelin treatment exhibiting a partial reversal of this situation, particularly at specific frequencies and intensity levels. Apelin treatment leads to a significant increase in total antioxidant status (TAS) and a reduction in total oxidant status (TOS) and oxidative stress index (OSI) in cochlea compared to diabetic groups. The levels of tumor necrosis factor-alpha (TNF-alpha) and interleukin 1-beta (IL-1 beta) in cochlear tissue were found to be significantly reduced in the apelin-treated group compared to the diabetic group.CONCLUSIONApelin-13 may have a protective effect on the auditory system and may be proposed as a potential new therapeutic strategy for the management diabetic auditory impairment.

News (Medical) associated with Apelin

03 Sep 2024

·www.prnewswire.com

Vasa Therapeutics Announces Initiation of Phase 1 First-in-Human Clinical Trial of VS-041 for the Treatment of Heart Failure with Preserved Ejection Fraction

Vasa Therapeutics granted MHRA Clinical Trial Authorization (CTA) for VS-041 for the treatment of heart failure with preserved ejection fraction (HFpEF) Company's seed funding extended to $11M ENCINITAS, Calif. and WROCLAW, Poland, Sept. 3, 2024 /PRNewswire/ -- Vasa Therapeutics ("Vasa"), a clinical stage biopharmaceutical company developing novel therapies for cardiovascular and metabolic aging, announced today that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) for Vasa to commence a Phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and pharmacokinetics of its investigational drug VS-041 in healthy adult participants. VS-041 is an oral compound with a novel mechanism of action for the potential treatment of heart failure with preserved ejection fraction (HFpEF). "The MHRA's authorization marks a major step forward in our mission to develop VS-041 as a disease-modifying therapy for HFpEF," said Artur Plonowski, MD, PhD, Chief Executive Officer, Vasa Therapeutics. "There are currently no approved HFpEF treatments that improve structural properties of myocardium and provide durable clinical benefit. By inhibiting the release of endotrophin, a biomarker and mediator of fibrotic and inflammatory responses, VS-041 has the potential to become the first personalized approach in HFpEF management that could be used in patients with elevated levels of endotrophin who have a high risk of an unfavorable prognosis." The commencement of the Phase 1 trial of VS-041 coincides with an extension of the Company's seed funding, bringing the total round to $11 million. The financing was led by Orphinic Scientific SA with participation from i&i Biotech Fund I SCSp. Proceeds will support the clinical development of VS-041 and advancement of Vasa's preclinical programs. About HFpEF and endotrophin Heart failure is a serious condition that affects more than 64 million people worldwide.1 Approximately 6.7 million Americans have heart failure, which is expected to increase to over 8.5 million Americans by 2030.2 Nearly half of patients with heart failure have heart failure with preserved ejection fraction (HFpEF)3, and the prevalence of HFpEF is increasing.2,4 Approximately 75% of patients with HFpEF will die within five years of initial hospitalization, and 84% will be rehospitalized.2 Currently approved therapies for HFpEF provide clinical improvement but do not result in disease modification and durable improvement upon discontinuation of the treatment.5 Endotrophin, a collagen type VI–derived signaling peptide, has been linked to cardiac metabolic dysregulation, inflammation, and fibrosis. Baseline plasma endotrophin levels HFpEF patients were shown to be strongly and independently associated with increased risk of poor outcomes (deaths or heart failure rehospitalizations).6 About VS-041 VS-041 is an oral compound that was discovered and developed by Vasa for the potential treatment of HFpEF. VS-041 robustly reduces cardiac fibrosis and significantly improves diastolic heart functions in a preclinical HFpEF model. The compound also inhibits the release of endotrophin from primary human cardiac fibroblasts. In GLP toxicology studies, VS-041 demonstrated a highly favorable safety and tolerability profile. Preclinical development of VS-041 was co-funded by the European Regional Development Fund and the Polish National Centre for Research and Development (POIR.01.01.01-00-1210/19-01). About Vasa Therapeutics Vasa is a privately held biopharmaceutical company developing therapeutics that target pathophysiologies of cardiovascular and metabolic aging. In addition to VS-041, Vasa developed a cutting-edge platform for long-acting apelin for combination treatment with incretins in obesity, especially for patients at risk for skeletal muscle loss or cardiovascular disease. As a monotherapy, long-acting apelin agonists could also be beneficial in treating muscle atrophy, heart failure, chronic kidney disease, or peripheral artery disease. Vasa's preclinical pipeline also includes a best-in-class inhibitor of CamKIId for heart failure and life-threatening arrhythmias. For more information, please visit References: James et al. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2018; 392: 1789–858. Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. PMID: 37797885; PMCID: PMC10864030. Dunlay SM, Roger VL, Weston SA, Jiang R, Redfield MM. Longitudinal changes in ejection fraction in heart failure patients with preserved and reduced ejection fraction. Circ Heart Fail. 2012 Nov;5(6):720-6. doi: 10.1161/CIRCHEARTFAILURE.111.966366. Epub 2012 Aug 30. PMID: 22936826; PMCID: PMC3661289. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327. Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022. Chirinos JA, Zhao L, Reese-Petersen AL, Cohen JB, Genovese F, Richards AM, Doughty RN, Díez J, González A, Querejeta R, Zamani P, Nuñez J, Wang Z, Ebert C, Kammerhoff K, Maranville J, Basso M, Qian C, Rasmussen DGK, Schafer PH, SeifFert D, Karsdal MA, Gordon DA, Ramirez-Valle F, Cappola TP. Endotrophin, a Collagen VI Formation-Derived Peptide, in Heart Failure. NEJM Evid. 2022 Oct;1(10):10.1056 SOURCE Vasa Therapeutics

INDPhase 1

29 Jul 2024

·pipelinereview.com

BioAge Announces First Patient Dosed in the STRIDES Phase 2 Clinical Trial Evaluating Azelaprag as a Novel Treatment for Obesity in Combination with Tirzepatide

Trial to evaluate weight loss efficacy of azelaprag, an oral small molecule apelin receptor agonist that mimics key biological effects of exercise STRIDES is being conducted in collaboration with Lilly’s Chorus clinical development organization Primary endpoint is weight loss at 24 weeks, with exploratory endpoints including body composition and physical activity RICHMOND, CA, USA I July 29, 2024 I BioAge Labs, Inc., (“BioAge”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the first patient has been dosed in the STRIDES Phase 2 clinical trial evaluating BioAge’s lead product candidate azelaprag in combination with tirzepatide for the treatment of obesity in adults aged 55 and older. Azelaprag is an orally available small molecule agonist of the apelin receptor APJ. Apelin is an exercise-induced signaling molecule (exerkine) that acts on APJ to mediate many of the metabolic benefits of physical activity. In a Phase 1b clinical trial in healthy older volunteers on 10 days of bed rest, azelaprag was observed to improve muscle metabolism, decrease muscle atrophy, and preserve measures of resting energy expenditure and cardiorespiratory fitness ( link ). Azelaprag has been well tolerated in more than 240 subjects across seven Phase 1 clinical trials to date. In mouse models of obesity, the addition of azelaprag approximately doubled the weight loss achieved with incretin drugs (GLP-1 receptor agonists) while restoring healthy body composition and physical function ( link ). “We believe combining azelaprag, an exercise mimetic, with tirzepatide, a GLP-1/GIP receptor agonist that decreases food intake, could provide a powerful pharmacological parallel to the exercise and diet interventions that form the foundation of obesity management,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “The STRIDES trial aims to demonstrate that activating apelin signaling with azelaprag is a potent complementary mechanism that can deliver increased weight loss efficacy in patients on incretins. In addition, this trial will provide a direct read-through to azelaprag’s potential as an orally available small molecule to achieve efficacy on par with injectable weight loss drugs when combined with incretins in an all-oral regimen.” STRIDES is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of azelaprag in combination with tirzepatide that will enroll approximately 220 obese individuals aged 55 years and older. The trial will evaluate the efficacy, safety, and tolerability of two oral doses of azelaprag (300 mg once or twice daily) in combination with tirzepatide (5 mg subcutaneous injection once weekly). The primary endpoint is mean percent change in body weight at 24 weeks. Additional exploratory endpoints include body composition, glycemic control, obesity-related biomarkers, and patient-reported outcomes related to health and quality of life. Top-line results are anticipated in the fourth quarter of 2025. STRIDES is being conducted in collaboration with Eli Lilly and Company’s (Lilly) Chorus clinical development organization. Lilly is providing tirzepatide for the trial ( link ). A second planned Phase 2 clinical trial will assess azelaprag in combination with semaglutide (Wegovy ® ) with initiation expected in the first half of 2025. Together, the trials will seek to support BioAge’s therapeutic goal of developing an all-oral combination product for obesity. About BioAge Labs BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that was observed to promote metabolism and prevent muscle atrophy on bed rest in a Phase 1b clinical trial. In mid-2024, BioAge initiated a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing orally available small molecule brain penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, also address key pathways in metabolic aging. SOURCE: BioAge Labs

Phase 2Phase 1

21 Jun 2024

·www.biospace.com

BioAge Labs Presents Preclinical Data for Apelin Receptor Agonist Azelaprag for Obesity Demonstrating Significant Improvements in Weight Loss and Body Composition When Combined with Incretin Drugs

Oral presentation delivered by Chief Medical Officer Paul Rubin, MD, at the American Diabetes Association's 84th Scientific Sessions, the world’s largest diabetes conference RICHMOND, Calif.--(BUSINESS WIRE)-- BioAge Labs, Inc. ("BioAge"), a clinical-stage biotechnology company developing therapeutic candidates for metabolic diseases, such as obesity, by targeting the biology of aging, today announced preclinical data for its lead product candidate azelaprag, an orally available small molecule agonist of the apelin receptor APJ, in combination with incretin agonists for the treatment of obesity. The data were presented in a talk by BioAge’s Chief Medical Officer and EVP-Research Paul Rubin, MD, at the American Diabetes Association's 84th Scientific Sessions. The conference, being held June 21–24 in Orlando, convenes more than 12,000 leading physicians, scientists, and health care professionals and features the latest scientific and therapeutic findings in diabetes. In a mouse model of obesity, the addition of azelaprag to the GLP-1/GIP receptor agonist tirzepatide increased total weight loss to 39%, approximately double that of tirzepatide monotherapy, restoring body weight to the range observed in lean control mice. Furthermore, the combination restored body composition and muscle function to that of lean controls. Similar results were observed when azelaprag was combined with semaglutide, a GLP-1 receptor agonist. Importantly, the synergistic weight loss observed in animals on combination therapy was not due to a further decrease in food intake. "We are highly encouraged by these preclinical data, which highlight the potential of azelaprag to significantly improve the weight loss and metabolic benefits of incretin therapy, the current standard of care for obesity," said Kristen Fortney, Ph.D., CEO of BioAge. "Given its oral availability and favorable tolerability profile, we believe azelaprag is ideally suited for combination use with incretin drugs and could enable a new generation of patient-friendly, all-oral obesity regimens that could rival or even surpass the efficacy of injectables while also promoting healthy body composition." Azelaprag is a potential first-in-class oral agonist of the apelin receptor APJ. Apelin is an exercise-induced signaling molecule (exerkine) that acts on APJ to mediate many of the metabolic benefits of physical activity. In a Phase 1b trial, azelaprag promoted muscle metabolism and prevented muscle atrophy in healthy older volunteers on bed rest (link). The study also showed that azelaprag shifted circulating protein biomarkers in a manner consistent with its function as an exercise mimetic, increasing predicted resting energy expenditure and cardiorespiratory fitness. BioAge plans to initiate a Phase 2 trial in mid-2024 evaluating azelaprag in combination with tirzepatide (Zepbound®) in older adults with obesity (link). The study is being conducted in collaboration with Eli Lilly and Company, which is providing tirzepatide, and Lilly's Chorus clinical development organization, which is advising on trial design and execution. Presentation Details: Title: Apelin Receptor Agonist Azelaprag Increases Weight Loss in Diet-Induced Obese Mice on Incretin Agonists and Restores Body Composition and Muscle Function to that of Lean Controls Abstract number: 118-OR Session: Beyond Glucose and Weight Reduction—Additional Effects of Incretin-Based Therapies Date/time: Friday, June 21, 2024, 4:15 – 4:30 PM Presenter: Paul Rubin, MD, Chief Medical Officer and EVP-Research, BioAge Labs About BioAge Labs, Inc. BioAge is a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. The company’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that promoted metabolism and prevented muscle atrophy on bed rest in a Phase 1b trial. In mid-2024, BioAge plans to initiate a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing BGE-100, a structurally novel NLRP3 inhibitor. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, also address key pathways in metabolic aging.

Phase 1Phase 2

100 Deals associated with Apelin

External Link

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiovascular Diseases	Phase 2	GB	AstraZeneca PLC	28 Mar 2018
Diabetes Mellitus, Type 2	Phase 2	GB	AstraZeneca PLC	28 Mar 2018

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EASD2015	Not Applicable	-	-	Apelin	ytpttgzruu(dqgcjkrzno) = Average frequency of NO hypothalamic release is significantly reduced following infusion of low-doses of apelin in the digestive tract (0,11 ± 0,003 Hz vs 0,12 ± 0,002 for control; P<0.001) cwujozdime (hrkdfijtai ) View more	-	16 Sep 2015
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