Livdelzi (seladelpar)
Research Synopsis
- Livdelzi (seladelpar) is a selective PPAR-δ agonist showing promise in treating primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).* -
- Initial studies demonstrated that seladelpar could reverse NASH pathology by improving insulin sensitivity and lowering liver damage indicators in obese, diabetic mice.* -
- In a significant phase 2 study for PBC, seladelpar was associated with increased liver enzyme levels, leading to early termination of the trial due to safety concerns.* -
- Subsequently, seladelpar showed efficacy in reducing symptoms of pruritus (itching) and improving sleep quality in patients with PBC during a 52-week study.* -
- The phase 3 ENHANCE trial revealed that patients receiving 10 mg doses of seladelpar exhibited marked improvement in liver function without serious side effects.* -
- Recent research highlighted the potential mechanisms of action, indicating that seladelpar decreases bile acid synthesis through the FGF21 signaling pathway.* -
- Concerns about liver enzymes and portal inflammation from early studies have raised questions regarding seladelpar's safety profile in diverse patient populations.* -
- Long-term studies have shown that seladelpar maintains efficacy in improving liver function markers over two years without significant adverse events.* -
- Despite previous safety issues, emerging evidence positions seladelpar as a promising second-line treatment for PBC, especially for patients intolerant to standard therapies.* -
- Overall, ongoing research emphasizes the need for careful monitoring of liver safety in conjunction with exploring the full therapeutic potential of seladelpar in liver diseases.*
Livdelzi (seladelpar)
The selective peroxisome proliferator-activated receptor-delta agonist seladelpar reverses nonalcoholic steatohepatitis pathology by abrogating lipotoxicity in diabetic obese mice.
London, UK
2 hours ago
1 Received
- Lipotoxicity contributes to insulin resistance and the development of nonalcoholic steatohepatitis (NASH), which is currently only fully reversible through weight loss.
- The study tested MBX-8025, a selective PPAR-δ agonist, on obese, dyslipidemic, and diabetic mice, finding that it improved insulin sensitivity and various lipid levels without significant weight loss.
- MBX-8025 also reduced liver damage indicators like alanine aminotransferase levels and inflammatory scores, suggesting it could be a new treatment option for NASH that works independently of weight reduction.
$100 - $150
Hourly Rate
Seladelpar (MBX-8025), a selective PPAR-δ agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study.
London, UK
2 hours ago
1 Received
- This study explores the effectiveness of seladelpar, a drug aimed at helping patients with primary biliary cholangitis who don't respond well to the standard treatment, ursodeoxycholic acid.
- Conducted over 12 weeks, the trial involved patients with elevated alkaline phosphatase levels, randomly assigning them to receive either seladelpar (in two different dosages) or a placebo while continuing ursodeoxycholic acid.
- Due to safety concerns, including significant increases in liver enzymes in some patients, the study was halted early after 41 participants were assigned to treatment, with only 12 patients included in the final analysis.
$100 - $150
Hourly Rate
The selective PPAR-delta agonist seladelpar reduces ethanol-induced liver disease by restoring gut barrier function and bile acid homeostasis in mice.
London, UK
2 hours ago
1 Received
- Alcohol-related liver disease leads to issues with bile acid metabolism and gut function.
- The PPARδ agonist seladelpar (MBX-8025) was tested in mice to see its effects on these problems caused by high ethanol consumption.
- Results showed that seladelpar reduced liver damage, improved bile acid levels, and restored gut function, indicating its potential as a treatment for alcohol-induced liver issues.
$100 - $150
Hourly Rate
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ENHANCE: Safety and Efficacy of Seladelpar in Patients With Primary Biliary Cholangitis-A Phase 3, International, Randomized, Placebo-Controlled Study.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Seladelpar improved measures of pruritus, sleep, and fatigue and decreased serum bile acids in patients with primary biliary cholangitis.
London, UK
2 hours ago
1 Received
- Seladelpar, a PPARδ agonist, was studied in PBC patients to evaluate its effects on cholestatic pruritus (itching) and quality of life over one year of treatment.
- In the study of 101 patients, significant improvement in pruritus was observed in 58% (5/10 mg) and 93% (10 mg) of patients, with many experiencing better sleep quality and reduced fatigue.
- The results indicate that Seladelpar notably improved both symptoms and biochemical markers in PBC patients, highlighting its potential as an effective treatment option.
$100 - $150
Hourly Rate
Selective PPARδ agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 via the fibroblast growth factor 21 signaling pathway.
London, UK
2 hours ago
1 Received
- * The study found that seladelpar decreases the expression of Cyp7a1, the key enzyme in bile acid synthesis, by increasing FGF21 in liver cells, which activates the JNK signaling pathway.
- * Blocking JNK or removing FGF21 halted seladelpar's effects on Cyp7a1, confirming that FGF21 is crucial for how PPARδ regulates bile acid production.
$100 - $150
Hourly Rate
A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis.
London, UK
2 hours ago
1 Received
- The study investigated the efficacy and safety of seladelpar, a medication for adults with primary biliary cholangitis (PBC) who are at risk of worsening disease, especially those intolerant to standard medication, ursodeoxycholic acid.
- Over 52 weeks, patients were given varying doses of seladelpar, showing significant reductions in alkaline phosphatase (ALP) levels, a marker of liver disease, particularly at higher doses (10 mg/day). Improvements were maintained over time.
- Results indicated that seladelpar was effective in improving liver function and reducing symptoms like pruritus (itching) without serious side effects, making it a promising option for PBC patients
$100 - $150
Hourly Rate
Combinations of an acetyl CoA carboxylase inhibitor with hepatic lipid modulating agents do not augment antifibrotic efficacy in preclinical models of NASH and fibrosis.
London, UK
2 hours ago
1 Received
- Dysregulated lipid metabolism in liver cells leads to nonalcoholic steatohepatitis (NASH), which is characterized by liver fat accumulation and related harm.
- Acetyl CoA carboxylase (ACC) inhibitors, such as firsocostat, help reduce liver fat and improve NASH symptoms but can cause increased levels of triglycerides (TG) in the blood.
- Combining ACC inhibitors with PPAR or thyroid hormone receptor agonists may reduce liver fat better while countering high blood TG levels, but these combinations don't appear to effectively reduce liver fibrosis.
$100 - $150
Hourly Rate
Seladelpar: an investigational drug for the treatment of early-stage primary biliary cholangitis (PBC).
London, UK
2 hours ago
1 Received
- Generic fibrates are sometimes used off-label for primary biliary cholangitis (PBC) but lack proven long-term benefits for liver health.
- The new fibrate, seladelpar, has shown encouraging results in trials, despite earlier safety issues.
- Seladelpar significantly improves liver-related tests and symptoms, with decreasing safety concerns, positioning it as a promising second-line treatment for PBC.
$100 - $150
Hourly Rate
Efficacy and safety of pharmacological interventions for pruritus in primary biliary cholangitis: A systematic review and meta-analysis.
London, UK
2 hours ago
1 Received
- Pruritus is a common issue for patients with primary biliary cholangitis (PBC), and the causes and effective treatments for this itching are still not well understood; researchers conducted a systematic review and meta-analysis to evaluate drug interventions for relief.
- They analyzed 23 randomized controlled trials (RCTs) with nearly 2,200 patients, finding that drugs like UDCA, methotrexate, and GSK2330672 demonstrated effectiveness in reducing pruritus compared to placebos.
- While some treatments improved blood serum levels like alkaline phosphatase, overall conclusions were limited due to high variability in results; however, moderate doses of UDCA and malotilate showed a potential to reduce adverse events in patients.
$100 - $150
Hourly Rate
Prevalence and clinical significance of portal inflammation, portal plasma cells, interface hepatitis and biliary injury in liver biopsies from patients with non-alcoholic steatohepatitis.
London, UK
2 hours ago
1 Received
- The study investigates the histological changes in portal tracts of liver biopsies from patients with non-alcoholic fatty liver disease (NAFLD) to understand the prevalence and clinical implications of portal inflammation and damage in the liver.
- Previous clinical trials for a PPARδ agonist called seladelpar were halted due to concerning findings of portal inflammation and bile duct abnormalities in NASH patients, prompting further examination of these histological features in NAFLD cases.
- The research included a thorough review of liver biopsies from patients with varying stages of NASH and control subjects, assessing histological parameters such as portal inflammation, plasma cells, and duct damage in order to better characterize the
$100 - $150
Hourly Rate
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Seladelpar in patients with primary biliary cholangitis: Need for a closer look!
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
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Reply to: "Seladelpar in patients with primary biliary cholangitis: Need for a closer look!".
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
PPAR agonists for the treatment of primary biliary cholangitis: Old and new tales.
London, UK
2 hours ago
1 Received
- Primary biliary cholangitis (PBC) is an autoimmune liver disease that can progress to serious liver damage if not treated adequately; Ursodeoxycholic Acid (UDCA) is the main treatment, with Obeticholic Acid (OCA) as a second option for those who don't respond to UDCA.
- There is a need for additional therapies due to the moderate rate of UDCA non-responders and recent concerns about OCA use in patients with cirrhosis.
- Research into the underlying causes of PBC is identifying new treatment options, particularly PPAR ligands, which show promise in clinical trials, with Bezafibrate already being used alongside UDCA in some centers.
$100 - $150
Hourly Rate
New Treatment Paradigms in Primary Biliary Cholangitis.
London, UK
2 hours ago
1 Received
- Primary biliary cholangitis (PBC) is a chronic autoimmune disease marked by symptoms like fatigue, itchiness, and abdominal pain, primarily affecting women and causing significant quality-of-life issues.
- Treatment focuses on relieving cholestasis and includes first-line medications like ursodeoxycholic acid, while newer options aim to reduce fibrosis and inflammation through PPAR agonists and other agents.
- Current research is exploring innovative therapies to manage symptoms and target underlying immune regulation, creating an optimistic outlook for individualized PBC treatment strategies.
$100 - $150
Hourly Rate
Functional and Structural Insights into the Human PPARα/δ/γ Targeting Preferences of Anti-NASH Investigational Drugs, Lanifibranor, Seladelpar, and Elafibranor.
London, UK
2 hours ago
1 Received
- No effective therapeutic drugs are available for nonalcoholic steatohepatitis (NASH), a liver condition that progresses from nonalcoholic fatty liver; PPAR subtypes (α, δ, γ) are potential targets for treatment.
- Current clinical trials are examining lanifibranor (a pan agonist) and saroglitazar (a dual agonist), while the development of other dual/pan agonists like seladelpar and elafibranor has been halted due to side effects or lack of efficacy.
- The study evaluated the binding and activation of lanifibranor, seladelpar, and elafibranor on PPARs using several assays and high-resolution cocrystal
$100 - $150
Hourly Rate
Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study.
London, UK
2 hours ago
1 Received
- The ENHANCE study assessed the efficacy and safety of seladelpar, a PPAR-δ agonist, in patients with primary biliary cholangitis who didn't respond well to or couldn't tolerate traditional treatment with UDCA.
- Participants were divided into three groups receiving either seladelpar (5 mg or 10 mg) or a placebo, with the primary goal of measuring liver function improvements after 12 months.
- Results showed that patients receiving 10 mg of seladelpar had significant liver function improvements and reduced itching compared to placebo, and the treatment was deemed safe with no serious side effects reported.
$100 - $150
Hourly Rate
Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials: Expert consensus from the Liver Forum.
London, UK
2 hours ago
1 Received
- The text discusses the challenges of assessing drug-induced liver injury (DILI) in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH) without routine liver biopsies.
- It details the efforts of the Liver Forum, which organized webinars and formed a Histology Working Group to develop consensus documents on the role of liver biopsy in DILI assessment during MASH trials from 2020 to 2022.
- The findings suggest that while liver biopsy is not always definitive, histologic evaluation can provide essential insights that influence patient management, clarify the nature of liver injury, and inform drug development decisions.
$100 - $150
Hourly Rate
Open-label, clinical trial extension: Two-year safety and efficacy results of seladelpar in patients with primary biliary cholangitis.
London, UK
2 hours ago
1 Received
- Seladelpar is a selective drug targeting receptors that help manage conditions like primary biliary cholangitis (PBC) by reducing cholestasis, inflammation, and itching.
- A long-term study evaluated seladelpar's safety and effectiveness in PBC patients, involving 106 individuals treated for up to 2 years.
- Results showed no serious side effects, and an increase in positive treatment responses over two years, indicating that seladelpar significantly improved liver function markers.
$100 - $150
Hourly Rate
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Editorial: The evolving paradigms and treatments for primary biliary cholangitis.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate