Iqirvo (elafibranor)

To treat primary biliary cholangitis in combination with ursodeoxycholic acid Drug Trials Snapshot

FDA Approval: 6/10/2024

Research Synopsis

  • Elafibranor, marketed under the brand name Iqirvo, is a dual agonist of the peroxisome proliferator-activated receptors (PPAR) α and δ, being investigated for its potential in treating metabolic diseases, especially nonalcoholic steatohepatitis (NASH) and type 2 diabetes.
  • Recent studies show elafibranor's ability to improve liver health by reducing fat accumulation, inflammation, and fibrosis in preclinical models, suggesting its therapeutic promise for NASH.
  • In clinical trials, elafibranor was found to induce resolution of NASH in a subset of patients without worsening liver fibrosis, indicating a favorable safety profile compared to traditional treatments.
  • The drug also demonstrated significant reductions in triglycerides and improvements in HDL cholesterol and insulin sensitivity, showcasing its dual benefit for lipid metabolism and glucose homeostasis.
  • Elafibranor has shown effectiveness in improving hepatic and peripheral insulin sensitivity, positioning it as a candidate for addressing insulin resistance prevalent in metabolic syndrome.
  • Research indicates that elafibranor might offer anti-inflammatory benefits and promote liver health without adverse cardiovascular effects, differentiating it from other diabetes medications.
  • While initial results are promising, experts call for more extensive long-term studies to validate elafibranor's efficacy and safety for broader patient populations and to understand its long-term impact on liver health.
  • As the prevalence of NAFLD and NASH rises globally, elafibranor represents a potential breakthrough in pharmacotherapy, addressing a significant unmet need in liver disease treatment.
  • The continued exploration of elafibranor's effects in human clinical trials will provide essential insights into its role in managing complex metabolic diseases alongside lifestyle interventions.

Related articles

Research articles about Iqirvo (elafibranor)

Iqirvo (elafibranor)

Effects of the new dual PPAR α/δ agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism.

London, UK

2 hours ago

1 Received

  • A study was conducted to evaluate the effects and safety of GFT505, a new medication, in patients with abdominal obesity and metabolic issues like dyslipidemia and prediabetes.
  • The research involved 94 and 47 participants respectively, who received either GFT505 or a placebo for 28 to 35 days, focusing on their blood lipid and glucose levels.
  • Results showed GFT505 significantly lowered triglycerides and improved HDL cholesterol, with some positive effects on glucose metabolism indicators, suggesting its potential as a treatment for metabolic syndrome.

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Dual peroxisome proliferator-activated receptor α/δ agonist GFT505 improves hepatic and peripheral insulin sensitivity in abdominally obese subjects.

London, UK

2 hours ago

1 Received

  • GFT505, a dual PPAR-α/δ agonist, was studied to see its effects on insulin sensitivity in abdominally obese, insulin-resistant males.
  • Over an 8-week period, GFT505 improved both peripheral and hepatic insulin sensitivity, with significant increases in glucose infusion rates and reductions in plasma free fatty acids and triglycerides.
  • The findings suggest that GFT505 is a promising drug candidate for treating type 2 diabetes and nonalcoholic fatty liver disease without safety concerns.

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Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis.

London, UK

2 hours ago

1 Received

  • Nonalcoholic fatty liver disease (NAFLD) encompasses a range of liver issues, from simple fat accumulation to advanced conditions like cirrhosis, with no current approved medication for treatment.* -
  • GFT505, a dual PPAR-α/δ agonist, showed effectiveness in preclinical studies, improving liver health by reducing fat, inflammation, and fibrosis in various animal models.* -
  • Clinical trials on humans with metabolic syndrome indicated that GFT505 lowered liver dysfunction markers, positioning it as a promising candidate for treating NAFLD/NASH.*

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Nuclear control of inflammation and fibrosis in nonalcoholic steatohepatitis: therapeutic potential of dual peroxisome proliferator-activated receptor alpha/delta agonism.

London, UK

2 hours ago

1 Received

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New peroxisome proliferator-activated receptor agonists: potential treatments for atherogenic dyslipidemia and non-alcoholic fatty liver disease.

London, UK

2 hours ago

1 Received

  • Novel PPAR modulators, specifically selective PPAR modulators (SPPARMs) and dual PPAR agonists, show potential in treating cardiometabolic disorders through effects on lipid levels, insulin sensitivity, and inflammation.
  • The review discusses emerging PPAR agonists and SPPARMs that could help with conditions like atherogenic dyslipidemia and non-alcoholic fatty liver disease (NAFLD).
  • Key candidates like ABT-335, K-877, INT131, MBX-8025, and GFT-505 demonstrate promising results in improving lipid profiles and insulin sensitivity, but further long-term trials are needed to verify their safety and effectiveness in cardiovascular and liver health.

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GFT505 for the treatment of nonalcoholic steatohepatitis and type 2 diabetes.

London, UK

2 hours ago

1 Received

  • PPARs are important nuclear receptors that help regulate metabolism and inflammation, and GFT505 is a new drug that targets PPARα and PPARδ to improve conditions like type 2 diabetes and nonalcoholic fatty liver disease (NAFLD).
  • This evaluation reviews GFT505's impact on metabolic diseases, highlighting its effectiveness in reducing triglycerides and improving cholesterol levels based on recent clinical trials.
  • Early studies suggest GFT505 is safe and has beneficial insulin-sensitizing and liver-protective effects, making it a promising candidate for treating NAFLD.

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The dual peroxisome proliferator-activated receptor alpha/delta agonist GFT505 exerts anti-diabetic effects in db/db mice without peroxisome proliferator-activated receptor gamma-associated adverse cardiac effects.

London, UK

2 hours ago

1 Received

  • GFT505 is a novel medication targeting liver receptors that showed effectiveness in reducing blood sugar levels and improving insulin sensitivity in diabetic mice.
  • Unlike traditional diabetes medications like rosiglitazone, GFT505 did not cause any negative effects on heart health after long-term use in monkeys.
  • Overall, GFT505 has a better safety profile and effectively addresses various aspects of type 2 diabetes without the cardiac side effects seen with other treatments.

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Early investigational drugs targeting PPAR-α for the treatment of metabolic disease.

London, UK

2 hours ago

1 Received

  • Fibrates have been used historically to treat dyslipidemias and show potential anti-inflammatory benefits, but they come with some side effects.
  • New drugs called selective PPAR modulators (SPPARMs), which are stronger PPAR-α agonists, are being researched for better treatment of dyslipidemia, insulin resistance, and non-alcoholic fatty liver disease (NAFLD).
  • New agents like K-877 and GFT-505 show promising results in managing dyslipidemia and may improve liver outcomes, but further long-term studies are needed to confirm their safety and effectiveness.

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Novel Pharmacotherapy Options for NASH.

London, UK

2 hours ago

1 Received

  • Diet and lifestyle changes are often recommended for treating nonalcoholic steatohepatitis (NASH), but they are difficult to implement and not very effective in advanced cases.
  • There is a growing consensus on the need for specific medications designed for NASH, moving away from previously used drugs not specifically developed for the disease.
  • Promising treatments like obeticholic acid and elafibranor have shown potential in improving liver health, and ongoing larger trials will further evaluate their effectiveness and safety along with new drug candidates in development.

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Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening.

London, UK

2 hours ago

1 Received

  • Elafibranor, an agonist for specific receptors, was tested for its safety and effectiveness in treating patients with nonalcoholic steatohepatitis (NASH) in a randomized, double-blind, placebo-controlled trial.
  • The study involved 276 participants assigned to receive either 80 mg or 120 mg of elafibranor daily for 52 weeks, with evaluations occurring every two months and liver biopsies taken afterward.
  • Results indicated that while there was no significant difference in the primary outcome between elafibranor and placebo groups, a higher percentage of patients in the 120 mg group experienced resolution of NASH without worsening fibrosis compared to the placebo group (19% vs. 12%, P

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Non-alcoholic fatty liver disease in 2016.

London, UK

2 hours ago

1 Received

  • - Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease globally and increasingly leads to liver transplants.
  • - Effective management focuses on weight loss and addressing metabolic syndrome, with recent findings indicating that fibrosis levels may be more crucial for predicting health outcomes than associated conditions like non-alcoholic steatohepatitis (NASH).
  • - Ongoing clinical trials are exploring potential treatments, such as obeticholic acid and GLP-1 analogues, while future research aims to enhance understanding of NAFLD's progression to better target affected patients.

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Treatment of nonalcoholic fatty liver disease: Where do we stand? an overview.

London, UK

2 hours ago

1 Received

  • Nonalcoholic fatty liver disease (NAFLD) has become the most prevalent liver disease globally, growing steadily in occurrence while other liver diseases have plateaued or declined, like hepatitis C.
  • The treatment of NAFLD is challenging for healthcare providers since standard medications are still experimental and lack substantial evidence, leading to a primary focus on lifestyle changes and managing related health issues.
  • This review surveys various proposed treatments for NAFLD, including weight loss drugs, insulin sensitizers, and emerging therapies like obeticholic acid, as well as ongoing research into new medications.

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Current and upcoming pharmacotherapy for non-alcoholic fatty liver disease.

London, UK

2 hours ago

1 Received

  • Non-alcoholic fatty liver disease (NAFLD) is highly prevalent and currently lacks approved therapies, making weight loss the main treatment although it's often difficult to sustain.
  • Recent advancements in understanding NAFLD have led to the development of new medications that target four key pathways: reducing hepatic fat accumulation, addressing oxidative stress, treating gut-related issues, and combating fibrosis.
  • Future treatment options will likely include a variety of pharmacological agents that can help manage NAFLD and its progression, providing clinicians with more tools to treat patients effectively.

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 NASH: A glance at the landscape of pharmacological treatment.

London, UK

2 hours ago

1 Received

  • * Regulatory bodies are fast-tracking drug approvals for NASH, with a focus on reducing liver inflammation without increasing fibrosis, and some drugs are advancing through clinical trials.
  • * While promising drug therapies are being developed, lifestyle modifications remain essential for managing NASH, especially in overweight or obese patients, as they significantly contribute to treatment effectiveness.

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JPEN Journal Club 25. Study Design.

London, UK

2 hours ago

1 Received

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Current and future treatment options in non-alcoholic steatohepatitis (NASH).

London, UK

2 hours ago

1 Received

  • * Although lifestyle changes and bariatric surgery show some effectiveness, there is currently no widely accepted medication for NASH, with pioglitazone and vitamin E recommended for specific patients.
  • * Ongoing clinical trials are exploring new treatments, and due to the urgent need for effective solutions, NASH is on an accelerated pathway for drug approval, with the expectation that a treatment could be available within the next five years.

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The therapeutic landscape of non-alcoholic steatohepatitis.

London, UK

2 hours ago

1 Received

  • Non-alcoholic steatohepatitis (NASH) is a liver disease marked by inflammation and cell damage, potentially leading to serious complications like cirrhosis due to factors such as insulin resistance and oxidative stress.
  • Current treatments for NASH often focus on medications since lifestyle changes tend to be ineffective, with earlier options including thiazolidinediones (like pioglitazone) and antioxidants (like vitamin E).
  • Recent developments include new drugs targeting various aspects of the disease, such as obeticholic acid and elafibranor, which have shown promise in clinical trials, emphasizing the need for a better understanding of NASH to improve treatment strategies.

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Emerging therapies for NASH - the future is now.

London, UK

2 hours ago

1 Received

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[Treatment Options in Non-alcoholic Fatty Liver Disease].

London, UK

2 hours ago

1 Received

  • * Current treatment primarily emphasizes diet and exercise to promote weight loss and metabolic improvement, but achieving significant weight loss is challenging for patients.
  • * While there are no definitive medications for NAFLD yet, promising drugs like obeticholic acid and elafibranor are undergoing advanced trials, indicating that targeted therapies addressing the disease’s underlying causes are on the horizon.

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