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 2

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

922

Literatures (Medical) associated with Apelin

01 Apr 2024·The Journal of steroid biochemistry and molecular biology

Possible role of apelin on the ovarian steroidogenesis and uterine apoptosis of infantile mice: An in vitro study

Article

Author: Roy, Vikas Kumar ; Gurusubramanian, Guruswami ; Anima, Borgohain

The expression of adipokines is well-known in the ovary and uterus. Recently we have shown that apelin and its receptor, APJ are developmentally regulated in the ovary and uterus of mice with elevation at postnatal day 14 (PND14). However, its role in the ovary and uterus of PND14 has not been investigated. Thus, we aimed to unravel the role of the apelin system (by APJ antagonist, ML221) on ovarian steroid secretion, proliferation, and apoptosis along with its role in uterine apoptosis in PND14 mice by in vitro approaches. The treatment of ML221 decreased estrogen, testosterone, and androstenedione secretion while increasing the progesterone secretion from the infantile ovary. These results suggest that apelin signaling would be important for ovarian estrogen synthesis in infantile mice (PND14). The abundance of 3β-HSD, 17β-HSD, aromatase, and active caspase3 increased in the infantile ovary after ML221 treatment. The expression of ERs and BCL2 were also down-regulated by ML221 treatment. The decreased BCL2 and increased active caspase3 by ML221 suggest the suppressive role of apelin on ovarian apoptosis. The APJ antagonist treatment also down-regulated the ER expression in the uterus along with increased active caspase3 and decreased BCL2 expression. In conclusion, apelin signaling inhibits the ovarian and uterine apoptosis via estrogen signaling in the ovary and uterus.

01 Mar 2024·Biochimica et biophysica acta. Biomembranes

Localized apelin-17 analogue-bicelle interactions as a facilitator of membrane-catalyzed receptor recognition and binding

Article

Author: Rainey, Jan K ; Murza, Alexandre ; Frampton, John P ; Phạm, Trần Thanh Tâm ; Marsault, Éric

The apelinergic system encompasses two peptide ligand families, apelin and apela, along with the apelin receptor (AR or APJ), a class A G-protein-coupled receptor. This system has diverse physiological effects, including modulating heart contraction, vasodilation/constriction, glucose regulation, and vascular development, with involvement in a variety of pathological conditions. Apelin peptides have been previously shown to interact with and become structured upon binding to anionic micelles, consistent with a membrane-catalyzed mechanism of ligand-receptor binding. To overcome the challenges of observing nuclear magnetic resonance (NMR) spectroscopy signals of a dilute peptide in biological environments, ¹⁹F NMR spectroscopy, including diffusion ordered spectroscopy (DOSY) and saturation transfer difference (STD) experiments, was used herein to explore the membrane-interactive behaviour of apelin. NMR-optimized apelin-17 analogues with 4-trifluoromethyl-phenylalanine at various positions were designed and tested for bioactivity through ERK activation in stably-AR transfected HEK 293 T cells. Far-UV circular dichroism (CD) spectropolarimetry and ¹⁹F NMR spectroscopy were used to compare the membrane interactions of these analogues with unlabelled apelin-17 in both zwitterionic/neutral and net-negative bicelle conditions. Each analogue binds to bicelles with relatively weak affinity (i.e., in fast exchange on the NMR timescale), with preferential interactions observed at the cationic residue-rich N-terminal and mid-length regions of the peptide leaving the C-terminal end unencumbered for receptor recognition, enabling a membrane-anchored fly-casting mechanism of peptide search for the receptor. In all, this study provides further insight into the membrane-interactive behaviour of an important bioactive peptide, demonstrating interactions and biophysical behaviour that cannot be neglected in therapeutic design.

31 Dec 2023·Renal failure

Apelin-13 alleviates contrast-induced acute kidney injury by inhibiting endoplasmic reticulum stress

Article

Author: Wu, Ting ; Kang, Yi-Xin ; Duan, Shao-Bin ; Wu, Xi ; Yan and, Ping ; Luo, Xiao-Qin ; Deng, Ying-Hao ; Wang, Lin ; Liu, Qian ; Wang, Hong-Shen

Contrast-induced acute kidney injury (CI-AKI) is a severe complication associated with significant morbidity and mortality, and effective therapeutic strategies are still lacking. Apelin is an endogenous physiological regulator with antioxidative, anti-inflammatory and antiapoptotic properties. However, the role of apelin-13 in CI-AKI remains unclear. In our study, we found that the protein expression levels of apelin were significantly downregulated in rat kidney tissues and HK-2 cells during contrast media treatment. Moreover, we explored the protective effect of apelin-13 on renal tubule damage using in vitro and in vivo models of CI-AKI. Exogenous apelin-13 ameliorated endoplasmic reticulum stress, reactive oxygen species and apoptosis protein expression in contrast media-treated cells and rat kidney tissues. Mechanistically, the downregulation of endoplasmic reticulum stress contributed critically to the antiapoptotic effect of apelin-13. Collectively, our findings reveal the inherent mechanisms by which apelin-13 regulates CI-AKI and provide a prospective target for the prevention of CI-AKI.

News (Medical) associated with Apelin

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

15 May 2024

·www.biospace.com

BioAge Labs Announces Inaugural Scientific Advisory Board to Support Advancement of Novel Therapeutics Targeting Metabolic Aging

Newly appointed advisors are world-renowned experts in obesity, diabetes, and cardiometabolic diseases, spanning basic biology to late-stage development 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 the formation of its Scientific Advisory Board (SAB). The SAB is composed of world-renowned leaders with expertise spanning metabolic disease biology, obesity medicine, and clinical development of blockbuster therapeutics. The SAB will work closely with BioAge's leadership team to advance the company's pipeline of novel treatments for age-related chronic metabolic diseases into mid- and late-stage clinical development. "We are thrilled to be working with this esteemed group of expert scientists and drug developers as we pioneer new approaches to treating age-related metabolic diseases," said Kristen Fortney, Ph.D., co-founder and Chief Executive Officer of BioAge. "Our advisors' wealth of experience across all phases of drug development, from scientific discovery through approval and commercialization, will be instrumental as we advance our lead product candidate into Phase 2 clinical trials for obesity." BioAge's lead product candidate azelaprag is an orally administered agonist of the apelin receptor APJ that has the potential to mimic the effects of exercise. In preclinical studies, azelaprag has demonstrated the ability to significantly increase weight loss while improving body composition and metabolic parameters when administered in combination with GLP-1 receptor agonists. The company plans to initiate a Phase 2 trial in mid-2024 evaluating azelaprag in combination with tirzepatide (Zepbound®) for the treatment of obesity in older adults (link). The members of the BioAge SAB are: Caroline M. Apovian, MD, FACP, FTOS, DABOM, Professor of Medicine at Harvard Medical School and Co-Director of the Center for Weight Management and Wellness (CWMW) at Brigham and Women’s Hospital. A leading expert in clinical management of obesity, Dr. Apovian has co-authored multiple U.S. and international obesity treatment guidelines. She co-founded the American Board of Obesity Medicine and served as President of the Obesity Society from 2017–2018. Cedric Dray, Ph.D., Associate Professor at INSERM and faculty member at the RESTORE Geroscience Center at Université de Toulouse III-Paul Sabatier. Prof. Dray has published multiple papers describing his pioneering work on apelin and is a world expert on the biology of the apelin pathway in aging, muscle physiology, and metabolic disease. The apelin pathway is the target of BioAge’s lead product candidate, azelaprag, expected to enter a Phase 2 trial for obesity starting in mid-2024. William Evans, Ph.D., Adjunct Professor of Human Nutrition at UC Berkeley and Adjunct Professor of Medicine (Geriatrics) at Duke University. As a former VP at GSK, he led the company's Muscle Metabolism Discovery Performance Unit, and has served as an investigator in multiple clinical trials of muscle aging. Dr. Evans was the first to describe sarcopenia, the age-related loss of muscle mass and strength. His research on muscle metabolism, aging, and functional capacity has resulted in more than 350 publications with more than 80,000 citations. Alexander Fleming, M.D., Founder and Executive Chairman of Kinexum, which provides strategic and operational guidance throughout the process of clinical development and drug commercialization. As a supervisory physician at the US FDA from 1986-98, Dr. Fleming led landmark regulatory reviews for first-in-class drugs for diabetes and other metabolic diseases including metformin, statins and insulin analogs. He also heads the not-for-profit Kitalys Institute, founded to catalyze progress in developing drugs and other ways to increase healthy longevity. Narimon Honarpour, M.D., Ph.D., Senior VP and Head of Global Development at Amgen, where he leads a team responsible for shaping program clinical development strategies through deep disease state knowledge and generating clinical trial evidence to enable pipeline progression. Since joining Amgen in 2011, Dr. Honarpour has held diverse roles across both cardiovascular and inflammation therapeutic areas. In 2019, he became head of Translational Medicine, and in his most recent prior role served as VP-Global Development for the General Medicine Therapeutic Area Head and JAPAC Development Head. Tim Rolph, D.Phil., Chief Scientific Officer and Co-Founder of Akero Therapeutics, a company devoted to developing novel therapies for patients with serious metabolic diseases, including efruxifermin, an FGF21 analog, for metabolic dysfunction–associated steatohepatitis (MASH). Previously, as Chief Scientific Officer of Pfizer's Cardiovascular & Metabolic Disease unit, Dr. Rolph oversaw the development of Steglatro (ertugliflozin) for type 2 diabetes and discovery of oral small-molecule GLP1R agonists and inhibitors of PCSK9 and DGAT2. "We are looking forward to working closely with the renowned experts on our SAB to harness the biology of apelin, an exercise mimetic, to improve the lives of patients living with obesity and other metabolic conditions,” said Eric Morgen, MD, co-founder and Chief Operating Officer of BioAge. “We will also leverage their broad expertise in drug development for metabolic diseases to guide the continued advancement of the other programs in our metabolic disease pipeline.” 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 the 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, with plans to IND by the end of 2024. 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 2Executive ChangePhase 1

13 Feb 2024

·www.biospace.com

BioAge Announces $170 Million Oversubscribed Series D Financing to Accelerate Development of Obesity and Metabolic Disease Therapeutics

Funding to advance Phase 2 clinical trials of azelaprag, an apelin receptor (APJ) agonist, in combination with Lilly’s Zepbound (tirzepatide) and therapeutic pipeline Azelaprag improves metabolic and muscle function and has potential as an oral drug to significantly increase weight loss and improve body composition in patients on GLP-1/incretin therapy James Healy, M.D., Ph.D., Managing Partner at Sofinnova Investments appointed as Chairman of the Board; Patrick Enright of Longitude Capital joins the Board of Directors of BioAge RICHMOND, Calif.--(BUSINESS WIRE)-- BioAge Labs (“BioAge”), a clinical-stage biotechnology company developing novel therapies for obesity and metabolic diseases by harnessing the biology of aging, announced today the completion of an oversubscribed Series D financing round of $170 million led by Sofinnova Investments. New investors including Longitude Capital, RA Capital, Cormorant Asset Management, RTW Investments, SV Health Investors, OrbiMed Advisors, Sands Capital, Pivotal bioVenture Partners, Osage University Partners, Lilly Ventures, and Amgen Ventures also participated in the round alongside existing investors including Andreessen Horowitz (a16z) Bio + Health. In connection with the financing, James Healy, M.D., Ph.D., managing partner at Sofinnova Investments, will join BioAge as Chairman of the Board, and Patrick Enright, managing director at Longitude Capital, will join as Board Director. The funding will be used to support Phase 2 clinical development of BioAge’s lead compound azelaprag, an oral apelin receptor agonist, in combination with Lilly’s Zepbound (tirzepatide) and other incretins for treatment of obesity. The studies with Zepbound are expected to begin in mid-2024, in collaboration with Eli Lilly’s Chorus organization. Azelaprag is an oral drug with the potential to significantly increase weight loss and improve body composition when combined with any incretin. In a Phase 1b trial, azelaprag promoted muscle metabolism, increased energy expenditure, and prevented muscle atrophy in healthy older volunteers at bedrest. In preclinical studies, azelaprag doubled the weight loss achieved on incretin drugs with improvements in body composition and muscle function. “We’re thrilled to partner with a top-tier syndicate of investors and pharma companies at the forefront of developing novel therapeutics for metabolic diseases,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. “This funding will support us through key clinical milestones and data readouts for our lead compound azelaprag in obesity, as well as advance our earlier-stage metabolic aging pipeline. The azelaprag program highlights our discovery platform’s ability to identify novel approaches to treating metabolic disease.” “We’re excited to support BioAge’s commitment to develop potentially life-changing therapies that improve patient lives in obesity and other metabolic diseases,” said Dr. Healy. “The BioAge management team has laid very important scientific and clinical groundwork for the azelaprag program, and we look forward to working with the team to advance its clinical programs.” About BioAge Labs BioAge is a clinical-stage biotechnology company that is harnessing the biology of human aging to develop novel targets and therapies for metabolic diseases. The company’s lead program, azelaprag, is a potential first-in-class oral APJ agonist entering Phase 2 trials in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge’s preclinical programs address key pathways in metabolic aging, based on novel insights from its discovery platform built on human longevity data. For more information, visit .

Phase 2Phase 1Executive Change

100 Deals associated with Apelin

External Link

KEGG	Wiki	ATC	Drug Bank
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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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERA2023	Not Applicable	Chronic Kidney Diseases	24	apelin (Healthy volunteers)	thlccnwdqo(yisgnbqnly) = mctyaoyulb kqdfppgcxf (lgkmsdeetj ) View more	-	15 Jun 2023
				apelin (Chronic kidney disease)	thlccnwdqo(yisgnbqnly) = cokhldtrgw kqdfppgcxf (lgkmsdeetj ) View more
ERA2023	Not Applicable	Chronic Kidney Diseases	30	Apelin (Patients with CKD)	jtijdqiaix(grrqlxkwkp) = zqkbgyqyel wemsdebhxo (kvdqpclywg ) View more	-	15 Jun 2023
				Apelin (Healthy volunteers)	jtijdqiaix(grrqlxkwkp) = ehnlvobhwl wemsdebhxo (kvdqpclywg ) View more
EASD2015	Not Applicable	-	-	Apelin	dbfnzohxzz(btxncimxuv) = 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) lorafcjaes (evsrefkaxk ) View more	-	16 Sep 2015
				apelin
ERS2015	Not Applicable	apelin	11	Pyr1apelin-13	vwcbwznomi(eebottgdgx) = ydwnwucmxb qyvpvawgje (ioiiflohul ) View more	Negative	01 Sep 2015
				Placebo	vwcbwznomi(eebottgdgx) = ohvdjkzapv qyvpvawgje (ioiiflohul ) View more
Pubmed \| J Mol Biol	Not Applicable	-	-	Apelin-13	nkbygivaig(qcqqsjqkyw) = Apelin also increased I(Na) "window" current by up to 600% bcbgcqocut (qogxmnzpgc )	-	01 Apr 2010
				Apelin-17

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