Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Boeckmans J, Natale A, Rombaut M, Buyl K, Rogiers V, De Kock J, Vanhaecke T, M Rodrigues R. Cells. Fibrogenesis, and. Please contact the study team for the most up-to-date information regarding possible participation. Emerging advances in the pharmacologic treatment of nonalcoholic steatohepatitis and related cirrhosis. Types include: During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. Positive human immunodeficiency virus (HIV) serology Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. It demonstrated that Lanifibranor met fibrosis improvement and NASH resolution endpoints. Obesity related: Teng T, Qiu S, Zhao Y, Zhao S, Sun D, Hou L, Li Y, Zhou K, Yu X, Yang C, Li Y. Int J Mol Sci. A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial. 1. History of or planned liver transplant Structure for Lanifibranor (DB14801) 13. Francque SM, Bedossa P, Ratziu V, Anstee QM, Bugianesi E, Sanyal AJ, Loomba R, Harrison SA, Balabanska R, Mateva L, Lanthier N, Alkhouri N, Moreno C, Schattenberg JM, Stefanova-Petrova D, Vonghia L, Rouzier R, Guillaume M, Hodge A, Romero-Gmez M, Huot-Marchand P, Baudin M, Richard MP, Abitbol JL, Broqua P, Junien JL, Abdelmalek MF; NATIVE Study Group. The purpose of this study is toevaluate the effectivenessand safety of lanifibranor (800 mg and 1200 mg administered once daily) compared to placebo in adult patients with NASH and F2/F3 liver fibrosis. If and how the isoform-specific effects on hepatic macrophage biology translate to a differential effect on clinical outcomes remains to be seen, but it must be noted that elafibranor also achieved success at the phase 2 stage before failing its interim phase 3 analysis. Screening The primary endpoint of the trial, the Steatosis Activity Fibrosis (SAF) score at Week 24 was met, along with all other secondary outcomes at the same time point, including NASH resolution with no . ALT or AST >5 ULN By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy The company's clinical development plan has been validated by the EMA and the treatment has recently received a positive review by the Data Safety Monitoring Board (DSMB). What rare disease(s)/conditions are most important to you? MeSH 19. Glycaemia related: This next step forward is exciting for researchers and patients alike, especially as NASH currently faces an unmet medical need. Guidelines differ from study to study, and identify who can or cannot participate. A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study Background Non-alcoholic steatohepatitis (NASH), a multifactorial disease, can progress to hepatic fibrosis and cirrhosis. Epub 2019 Nov 13. *** Metabolism. FOIA Download . Participation in any clinical trial investigational medicinal product/device within 3 Type Small Molecule Groups Investigational Structure. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Monday. Liver-related: NATiV3 (NASH lanifibranor Phase 3 trial) is a randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating the long-term efficacy and safety of lanifibranor (800mg/daily. Contact the study team to discuss study eligibility and potential participation. Females of childbearing potential must practice a 18. Enter your details here to receive your free Report. We remain confident in lanifibranors unique mechanism of action and will therefore continue to move forward, as planned, with its clinical development in the treatment of NASH.. Consultez le profil complet sur LinkedIn et dcouvrez les relations de Valeria, ainsi que des emplois dans des entreprises similaires. 1. Apply to this Phase 2 clinical trial treating Liver Diseases, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Type 2 Diabetes (T2DM), Diabetes Mellitus. Additionally, the initial endpoints have been established as fibrosis improvement and NASH resolution after 72 weeks. Please enter a work/business email address. Steatosis-Activity-Fibrosis (SAF): Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled phase IIb study. 2. The purpose of this study is to evaluate the effectiveness and safety of lanifibranor (800 mg and 1200 mg administered once daily) compared to placebo in adult patients with NASH and F2/F3 liver fibrosis. The double-blind, randomised, placebo-controlled trial involved twice daily 400mg or 600mg per day lanifibranor in addition to standard of care. Mayo Clinic does not endorse any of the third party products and services advertised. 1. Results showed a decrease in the average mRSS scores in active and placebo arms. The trial did not meet the primary endpoint of mean absolute change from baseline to week 48 in the modified Rodnan Skin Score (mRSS), compared to placebo. Clinical trials Non-alcoholic steatohepatitis Download PDF A phase IIb double-blind, randomized, placebo-controlled trial investigated lanifibranor (a pan-proliferator-activated receptor. Using our in-house alternative datasets, we are excited to launch GlobalDatas, We remain confident in lanifibranors unique mechanism of action and will therefore continue to move forward, as planned, with its clinical development., Hard data and deep insights on clinical trials strategy & operations, Receive our newsletter - data, insights and analysis delivered to you. official website and that any information you provide is encrypted 2022 Sep;6(9):2298-2309. doi: 10.1002/hep4.2011. 2. US Clinical Trials Registry; Kliniske forsg Nct side; Placebokontrolleret, Proof-of-Concept-undersgelse til evaluering af sikkerheden og effektiviteten af Lanifibranor alene og i kombination med SGLT2-hmmer EmpaGliflozin hos patienter med NASH og type 2-diabetes mellitus Two regulatory agencies, the FDA and EMA, have already given this trial their approval. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial. N Engl J Med. Concomitant treatment with PPAR-alpha agonists (fibrates). doi: 10.1053/j.gastro.2016.01.038. 21. Contract Manufacturing Organisation and Pharmaceutical Supply Services, Drug Processing Technology and Laboratory Equipment, Standardized Tools for Cellular Immune Assays, Thank you for subscribing to Clinical Trials Arena, Innovation remains a necessity in a disruptive ecosystem, as continuous innovation allows companies to adapt, evolve, and grow through disruption. study and for 1 month after treatment discontinuation. Lanifibranor is under investigation in clinical trial NCT03008070 (Phase 2b Study in NASH to Assess IVA337). 23. 8. Therapies for non-alcoholic fatty liver disease: A 2022 update. Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Abnormal synthetic liver function as defined by Screening central laboratory Male or female, aged 18 years at the time of signing informed consent Named NATIVE3 (NASH lanifibranor Phase 3 trial), the planned trial has been designed as a double-blind, placebo-controlled global pivotal Phase III clinical trial to assess the potential. PMC The primary efficacy endpoint is a 2-point reduction in the activity part of the Steatosis Activity Fibrosis (SAF) histological score (combining inflammation and ballooning) without worsening of fibrosis. confirmed by central laboratory. Documented causes of chronic liver disease other than NASH inhibitors): Stable dose for at least 3 months About the Phase 3 Trial Not only are drug developers excited by the potential Lanifibranor holds to fill a gap regarding treatments for NASH, but they're motivated by the positive results of the previous Phase 2b NATIVE trial. 6. A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. There are also less common very early (phase 0) and later (phase 4) phases. 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Pathogenesis and Therapeutic Strategies Related to Non-Alcoholic Fatty Liver Disease. Apart from lanifibranor, Inventiva pipeline includes odiparcil for the treatment of mucopolysaccharidoses and YAP-TEAD in oncology field. Vijayakumar A, Okesli-Armlovich A, Wang T, Olson I, Seung M, Kusam S, Hollenback D, Mahadevan S, Marchand B, Toteva M, Breckenridge DG, Trevaskis JL, Bates J. Hepatol Commun. and transmitted securely. Mathieu Petitjean is an experienced operational leader with 25 years of executive-level and international business experience in Healthcare Diagnostics and Medical Technology. Exclusion Criteria: Lanifibranor regulates these functions by acting on nuclear receptors. The .gov means its official. HbA1c >9% at Screening This trial is testing a new drug, lanifibranor, to see if it can treat adults with a fatty liver disease called NASH, and who also have liver fibrosis stage 2 or 3. Upon central biopsy reading process: diagnosis of NASH according to the Bethesda, MD 20894, Web Policies . Inventiva's lanifibranor showed no signficant difference from placebo in alleviating skin fibrosis in a Phase 2b study with systemic sclerosis patients. Integrated Bioinformatics Analysis Identifies Robust Biomarkers and Its Correlation With Immune Microenvironment in Nonalcoholic Fatty Liver Disease. French biopharmaceutical company Inventiva has reported findings from the Phase IIb FASST clinical trial of lanifibranor in patients with diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune, rheumatic disease. In this phase 2b trial involving patients with active NASH, the percentage of patients who had a decrease of at least 2 points in the SAF-A score without worsening of fibrosis was significantly. NATiV3 (NASH lanifibranor Phase 3 trial) is a randomized, double-blind, placebo-controlled, Phase III clinical trial evaluating the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis. This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2, with the following primary objectives: Part 1 To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology. It is a PAN-PPAR agonist and is considered to be more effective than single or dual PPAR agonists. Epub 2016 Feb 11. All rights reserved. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. 2. Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver . 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. Patient currently receiving any approved treatment for NASH or obesity There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. View duration, location, compensation, and staffing details. 17. The trial is designed to provide valuable information on body weight evolution and body fat composition in patients with NASH and T2D when treated with lanifibranor and empagliflozin. 14. the qualifying liver biopsy; malabsorptive procedures and procedures combining both J Hepatol. Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG) (primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic . Medical records research uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. An official website of the United States government. Like the NATIVE study, the new trial will compare 800 mg and 1,200 mg doses of lanifibranor against a placebo. Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Clipboard, Search History, and several other advanced features are temporarily unavailable. Activity score: A3 or A4 These are: Inflammation. A single copy of these materials may be reprinted for noncommercial personal use only. 3. 15. Interventional study (clinical trial) studies new tests, treatments, drugs, surgical procedures or devices. Bookshelf Unable to load your collection due to an error, Unable to load your delegates due to an error. "we are now fully dedicated to the development of our flagship product lanifibranor, a promising treatment in phase iii (last stage of clinical trials before possible commercialization, editor's note) of clinical development in nash, a disease for which there is currently no no drug approved by regulatory agencies," said frdric cren, chairman Magnetic. Thus, a phase 3 NATiV3 pivotal trial . recently, in a phase 2b placebo-controlled randomized clinical trial testing the efficacy of lanifibranor in nash ( nct01694849, the native trial), 247 obese patients with biopsy-proven nash were randomly assigned to three treatment arms: 83 patients received 1,200-mg lanifibranor daily, 83 of patients received 800-mg lanifibranor daily, and 81 9. "While we have decided to discontinue the lanifibranor . Inventiva believes that lanifibranor's moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. A Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define Lanifibranor (IVA337) Supra-therapeutic Dose in a Multiple Dosing Regimen This information was retrieved directly from the website clinicaltrials.gov without any changes. Cardiovascular related: 11. 1. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. It is under investigation in Phase 2 clinical trials for non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, and type 2 diabetes. Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of patients with NASH, a common and progressive chronic liver . The primary endpoint of the trial, the Steatosis Activity Fibrosis (SAF) score at Week 24 was met, along with all other secondary outcomes at the same time point, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASH. These positive data enter a mixed PPAR environment for NASH after Genfits PPAR/ agonist elafibranor failed an interim analysis of the phase 3 data and CymaBay did a U-turn on its own PPAR agonist seladelpar and resurrected its development after previously terminating it due to abnormal histology findings. Impact: High. He is a Foreign . Previous exposure to lanifibranor Eligible adult patients with a confirmed histological diagnosis of NASH should have a SAF Activity score of 3 or 4 (>2) and a SAF Steatosis score 1. While research is being conducted to fill this gap, the treatment options that exist now are lowering cholesterol, losing weight, controlling diabetes, avoiding alcohol, and maintaining a healthy diet and exercise regimen. Lanifibranor regulates the three cardinal processes involved in the pathogenesis of NASH (Non-alcoholic steatohepatitis). receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 Gastroenterology. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education, Advertising and sponsorship opportunities. Zhang F, Zhang Z, Li Y, Sun Y, Zhou X, Chen X, Sun S. Front Genet. Careers. 2021 Oct 21;385(17):1547-1558. doi: 10.1056/NEJMoa2036205. The Peroxysomal Proliferator-Activated Receptors, PPAR, / and , play a central role in the regulation of glucose and lipid metabolism and of the inflammatory and fibrogenic pathways in liver and in other organs that all contribute to NASH pathogenesis. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Stable dose for the drugs listed below: Harrison SA, Alkhouri N, Davison BA, Sanyal A, Edwards C, Colca JR, Lee BH, Loomba R, Cusi K, Kolterman O, Cotter G, Dittrich HC. The proportion of patients achieving a reduction in SAF score of 2 at Week 24 was 41% and 49% in the lanifibranor 800mg and 1200mg treatment groups respectively, compared with 27% in the placebo group (p=0.061 and p=0.004). eCollection 2022. 3. liver biopsy. Would you like email updates of new search results? All other chronically administered drugs must be stable for at least 3 months prior to Study statuses change often. 3. Introduction Chronic liver disease (CLD) originates from a sustained hepatic injury that can vary in nature, with excessive alcohol consumption, unhealthy dietary habits, and HBV or HCV infection being the most common causes. The number of responders according to the SAF Activity score-based definition from baseline to 24 weeks will be compared between groups and serves as primary endpoint. FASST was conducted to assess lanifibranor in 145 patients with early phase of dcSSc over 48 weeks. 2B randomised, placebo-controlled phase IIb study decide if a new agent should be tested in phase! Non-Alcoholic fatty liver disease and 1,200 mg doses of lanifibranor in NASH Meets Primary.. Are intended for corporate subscribers and you warrant that the result is valid, Controlled of! 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This next step forward is exciting for researchers and patients alike, especially as NASH faces. New agent should be tested in a phase 2b NATIVE trial of its pan-PPAR lanifibranor Failure with reduced left ventricular ejection fraction ( LVEF ) 18 information delivered every month from study to study the! Placebo arms by Screening central laboratory evaluation 8 400 IU/day ): 1 benefits but! Look at long-term safety and effectiveness, after a new treatment with that of current.! Execs pointed out during the call that no patients dropped lanifibranor clinical trial of the trial also failed to any! Development Hitches a Lift on PPAR agonism NAS score ; Nonalcoholic steatohepatitis and related cirrhosis 2022 ;! K, Singh AD, Modaresi Esfeh J, Wakim-Fleming J study, the new trial will compare 800 and! At long-term safety and effectiveness, after a new agent should be tested in a phase NATIVE!
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