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Medscape
12-05-2025
- Health
- Medscape
Semaglutide Therapy Improves Liver Histology in MASH
Adult patients with metabolic dysfunction–associated steatohepatitis (MASH) and moderate or advanced liver fibrosis showed improved liver histology with a once-weekly dose of semaglutide (Wegovy), an ongoing randomized placebo-controlled trial reported. The glucagon-like peptide 1 receptor agonist (GLP-1 RA) is currently a candidate for treating MASH. Preliminary results of the two-part phase 3, double-blind ESSENCE trial, conducted in at 253 clinical sites in 37 countries, were published in The New England Journal of Medicine. A previous phase 2 study by Loomba et al suggested semaglutide was effective in reducing liver injury. 'That study, however, did not show improvement in liver fibrosis, which this study has done,' study co-lead Philip Newsome, PhD, professor in the Department of Immunology and Immunotherapy and Honorary Professor of Experimental Hepatology at the University of Birmingham in Birmingham, England, told Medscape Medical News . 'The results aligned with expectations in that that the impact on liver fibrosis was anticipated — but with some uncertainty, so this study is important in that regard.' Study Details From May 2020 to April 2023, researchers led by Newsome and Arun J. Sanyal, MBBS, MD, of Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University School of Medicine in Richmond, Virginia, randomized 1197 patients with a mean age of 56 years. Of these, 57% were women and 67.5% were White individuals. Mean body mass index was 34.6, and 55.9% had type 2 diabetes. All had biopsy-defined MASH and fibrosis stage 2 or 3 according to the Nonalcoholic Steatohepatitis Clinical Research Network classification and a Nonalcoholic Fatty Liver Disease Activity Score ≥ 4. Rates of fibrosis were 31.3% for stage 2 fibrosis and 68.8% for stage 3. Diverse geographic site locations included Asia (25.1%), Europe (25.3%), North America (35.0%), and South America (7.9%), and others (6.8%). In a 2:1 ratio, they were assigned to receive once-weekly subcutaneous semaglutide at a dose of 2.4 mg or placebo for 240 weeks. A planned interim analysis of the first 800 patients was done at week 72, with primary endpoints being resolution of steatohepatitis without worsening of liver fibrosis and reduction in liver fibrosis without worsening of steatohepatitis. Resolution of steatohepatitis without worsening of fibrosis occurred in 62.9% of the 534 patients in the semaglutide group and in 34.3% of the 266 patients in the placebo group (estimated difference, 28.7 percentage points; 95% CI, 21.1-36.2, P < .001). A reduction in liver fibrosis without worsening of steatohepatitis was reported in 36.8% of semaglutide recipients and 22.4% of placebo recipients (estimated difference, 14.4 percentage points; 95% CI, 7.5-21.3, P < .001). In secondary findings, the combined resolution of steatohepatitis and reduction in liver fibrosis was reported in 32.7% in the semaglutide group vs 16.1% in the placebo group (estimated difference, 16.5 percentage points; 95% CI, 10.2-22.8; P < .001). The mean change in body weight was −10.5% with semaglutide and −2.0% with placebo (estimated difference, −8.5 percentage points; 95% CI, −9.6 to −7.4, P < .001). Mean changes in bodily pain scores did not differ significantly between arms. The histologic benefits of semaglutide also emerged in improvements on all prespecified noninvasive tests — including aspartate transaminase and alanine transaminase levels and liver stiffness. Emerging evidence has suggested an association between reductions in liver stiffness and clinical benefit. Gastrointestinal adverse events were more common in the semaglutide group. Commenting on the study from a nonparticipant's perspective, Naga P. Chalasani, MD, professor of gastroenterology and hepatology at Indiana University School of Medicine in Indianapolis, said results from the ESSENCE trial were 'long awaited and they certainly advance the field of MASH clinical trials substantially.' Furthermore, he added, the results are well aligned with those of a phase 2B trial of semaglutide by Newsome and colleagues for what was then termed nonalcoholic steatohepatitis, and they also align with what is known about the positive role of incretins, digestive hormones imitated by GLP-1s to improve liver health in patients with MASLD and MASH.' 'The results from this study certainly make a case for semaglutide to be the backbone therapy for diabetic or obese patients with MASH and fibrosis,' Chalasani said. 'More than 80% of patients with MASH and fibrosis have either diabetes and/or obesity.' He added that a better understanding is needed of how semaglutide works in patients with MASH cirrhosis since the previous small study was unsuccessful. 'But this may need to be repeated as the published study was underpowered. Outcomes in the ESSENCE trial will help to clarify whether semaglutide will improve clinical outcomes beyond improving liver histology.' According to Newsome, GLP-1s will become the backbone of therapy in MASH given their range of metabolic and liver benefit. But questions remain, he said. 'Will there be further improvements with longer treatment with semaglutide? What noninvasive tests should we use to determine treatment success? Which patients will benefit from combination treatment?' This study was supported by Novo Nordisk, the manufacturer of Wegovy. Sanyal reported having various financial relationships with multiple private-sector companies, including Novo Nordisk. Newsome reported consulting for Novo Nordisk and Boehringer Ingelheim. Several study coauthors reported having similar relationships with pharmaceutical companies or employment with Novo Nordisk.
Time of India
07-05-2025
- Health
- Time of India
Can Ozempic reverse liver disease? New study holds the answer
The landmark study Why is this big news? Should everyone with liver disease be on Ozempic? Increasing coffee consumption may lower severity of non-alcoholic fatty liver: Study If you've been hearing a lot about Ozempic lately, you're not alone. Once a quiet diabetes drug, it shot to fame as a weight-loss injection. But now, it might be about to earn a new title: a potential game-changer for liver disease. You read that right—Ozempic may not just help you shed pounds, but also reverse serious and common liver is the brand name for semaglutide, a GLP-1 receptor agonist originally designed to manage blood sugar in people with type 2 diabetes. It works by mimicking a hormone that controls hunger, making you feel full faster and eat less. That's how it gained massive popularity for weight loss. But researchers recently discovered another potential benefit that could impact millions—its ability to tackle non-alcoholic steatohepatitis, or is an advanced form of non-alcoholic fatty liver disease (NAFLD), a condition where fat builds up in the liver unrelated to alcohol use. Over time, that fat causes inflammation and liver cell damage, leading to fibrosis (scarring), cirrhosis, or even liver failure. There's currently no approved drug specifically for treating is where Ozempic comes in—and it's not just hype.A new clinical trial, published in the New England Journal of Medicine , revealed that semaglutide can significantly improve liver health in NASH study was led by Dr Arun Sanyal of the Virginia Commonwealth University (US), and Dr Philip Newsome of King's College followed over 800 people diagnosed with NASH and liver fibrosis. Participants were randomly given either a weekly injection of semaglutide (Ozempic) or a placebo for 72 weeks. The results? than 62.9% of patients taking semaglutide saw a complete resolution of NASH, compared to just 34.3% in the placebo group. Improvements in both MASH and fibrosis were seen in 32.7 percent of the participants on semaglutide, compared to 16.1 percent of the placebo better? People also lost weight which is linked to liver now, patients with NASH have been told the same old advice: lose weight, exercise more, and eat better. While lifestyle changes do work, they're often not enough for people already dealing with fibrosis and significant liver inflammation. Plus, not everyone is able to lose the amount of weight needed to improve liver semaglutide, patients may finally have a real treatment that goes beyond just symptom so fast. While this is exciting news, semaglutide isn't approved yet specifically for NASH or fatty liver disease—it's currently approved for type 2 diabetes and used for weight like any drug, it comes with side effects—nausea, vomiting, constipation, and possible risks for pancreatitis or gallbladder issues in some people. So, it's not a universal fix—but it could be a huge step forward for those battling progressive liver disease with few other options, once it gets approved. Don't make any changes without talking to your doctor.
Express Tribune
05-05-2025
- Health
- Express Tribune
Ozempic shows promise in reversing liver disease, landmark global research finds
Pens for the diabetes drug Ozempic sit on a production line to be packaged at the Danish drugmaker Novo Nordisk's site in Hillerod, Denmark, September 26, 2023. PHOTO:REUTERS Listen to article A major international clinical trial has found that Ozempic (semaglutide), a medication already widely used to manage type 2 diabetes and obesity, significantly improves outcomes in patients with metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease. Published in the New England Journal of Medicine, the Phase III ESSENCE trial marks the first regulatory-level study to demonstrate that a treatment can halt and potentially reverse liver damage caused by MASH. The study, conducted across 253 sites in 37 countries, was led by Professor Philip Newsome of King's College London and Professor Arun Sanyal of Virginia Commonwealth University. Over 800 participants received weekly injections of 2.4 mg of Ozempic or a placebo for 72 weeks, alongside lifestyle counseling. Results showed that 62.9% of patients on Ozempic saw a reduction in liver inflammation, compared to 34.3% on placebo. Additionally, 36.8% of those treated with Ozempic experienced improvement in liver fibrosis versus 22.4% of the placebo group. The study population included a high percentage of individuals with obesity (around 75%) and type 2 diabetes (over 50%). Patients taking Ozempic also saw significant weight loss and improvements in liver enzymes. However, gastrointestinal side effects such as nausea and diarrhea were more common in the treatment group. MASLD, the broader condition that includes MASH, affects one in five people in the UK. Currently, no medications are licensed to specifically treat it. The research team plans to monitor 1,200 patients over five years to assess long-term benefits and safety of Ozempic in liver disease treatment.
Hans India
04-05-2025
- Health
- Hans India
Diabetes drug offers hope for advanced liver disease
In a significant medical breakthrough, researchers from King's College London have found that semaglutide, a drug commonly used to treat type 2 diabetes, can halt and even reverse liver damage in patients suffering from metabolic dysfunction-associated steatohepatitis (MASH), a severe and potentially life-threatening liver disease. The study, published in the New England Journal of Medicine, involved 800 participants across 37 countries, making it one of the largest trials of its kind. Participants were randomly given either a 2.4 mg weekly injection of semaglutide or a placebo, along with standard lifestyle counselling. After 72 weeks, the findings were highly encouraging: • 62.9% of patients in the semaglutide group saw a reduction in liver inflammation (steatohepatitis), compared to just 34.3% in the placebo group. • Around 37% of patients on semaglutide showed improved liver fibrosis, a condition involving scarring of liver tissue, versus 22.4% of those on placebo. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which are known to reduce fat in the liver and curb liver scarring. The drug also led to an average weight loss of 10.5% among patients, further benefiting those with underlying metabolic conditions like obesity and type 2 diabetes—both of which are closely linked to liver disease. MASH is a more aggressive form of Metabolic dysfunction-associated steatotic liver disease (MASLD), previously termed non-alcoholic fatty liver disease (NAFLD). MASLD is driven by excessive fat buildup in the liver and is associated with serious health risks, including cardiovascular disease. Professor Philip Newsome from King's College London, who led the study, remarked, 'MASLD is a growing problem worldwide and this trial will provide real hope for patients with MASH. While these results must be treated with caution, the analysis shows semaglutide can be an effective tool to treat this advanced liver disease.' Despite the optimism, the researchers acknowledged some side effects, primarily gastrointestinal issues such as nausea, vomiting, diarrhoea, and constipation, which were more frequent among those on semaglutide. With the prevalence of MASLD on the rise globally, these findings could represent a turning point in how liver disease is treated, particularly in patients with few existing options for intervention.
Hans India
01-05-2025
- Health
- Hans India
Diabetes drug can effectively treat fatty liver: Study
New Delhi: Treating patients with semaglutide -- an anti-diabetic medication -- can halt and even reverse liver disease, according to a study. Researchers from the King's College London, UK, chose to investigate semaglutide as a potential treatment because this class of drug helps reduce fat and liver scarring for people with metabolic dysfunction associated steatohepatitis (MASH) -- a life-threatening form of liver disease. MASH is a more severe form of Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD) -- a long-lasting liver condition caused by having too much fat in the liver. It is closely linked with obesity as well as conditions such as type 2 diabetes and heart and circulatory disease. In the trial conducted across 37 countries around the world, 800 participants were randomly assigned to receive a once-weekly injection of 2.4 milligrams of semaglutide or placebo, alongside lifestyle counselling. The results, published in the New England Journal of Medicine, showed that after 72 weeks of treatment, 62.9 per cent of participants experienced a reduction in steatohepatitis (inflammation of the liver with fat accumulation in the liver) versus 34.3 per cent for participants who took the placebo. About 37 per cent of the semaglutide group also had improvements in their liver fibrosis versus 22.4 per cent in the placebo group. "MASLD is a growing problem worldwide and this trial will provide real hope for patients with MASH. While these results must be treated with caution, the analysis shows semaglutide can be an effective tool to treat this advanced liver disease," said Prof Philip Newsome, from King's College. Researchers also found that people receiving semaglutide had improvements in liver enzymes and other blood measures of liver fibrosis, as well as 10.5 per cent weight loss. However, gastrointestinal adverse events were more common in the semaglutide group, such as nausea, diarrhoea, constipation, and vomiting, the team said.
