Friday June 24, 2022 (London, UK) — Results from two trials have given researchers hope that significant progress can be made against the rise in non-alcoholic fatty liver disease (NAFLD), now the world´s fastest growing disease which affects one in four people around the globe.
The results were presented today at the International Liver Congress 2022 (ILC 2022) in London. Convened by the European Association for the Study of the Liver (EASL), the annual event returns this edition in a hybrid format with some 5000 scientists, doctors, public health officials and patient groups attending in-person at the ExCel London venue this week. Deputy Mayor of London for Business Rajesh Agrawal opened the event on Wednesday.
A first in-human trial of the drug Pemvidutide has shown that it is remarkably effective at reducing a person`s weight but that what sets its aside form weight loss drugs is that it simultaneously reduces liver fat which in excess levels can be life threatening.
In a separate randomised trial comparing two types of weight reducing diets, researchers have concluded that a low carbohydrate high fat diet is much more effective at reducing liver fat in people living with type 2 diabetes than a high carbohydrate low fat diet.
“The global burden of NAFLD is so high that we´re going to need all the prevention and treatment tools at our disposal to make any real inroads over the coming years,” said Aleksander Krag, Vice Secretary-General of EASL who is also Professor and senior consultant of Hepatology and Director of the Odense Liver Research Centre at the University of Southern Denmark and Odense University Hospital in Denmark.
“Prevention through diet is a no-brainer policy: it´s something most people can do of their own accord, and it costs governments very little. For the sake of our younger generations, we have to take the issue of good diet seriously.
“Banning advertising of junk food, for instance, would be a good start.
“But educating young people and their families is going to be the key to unlocking this looming public health disaster. People need reassuring about why a good diet is so important in the long-term which ensures they live more healthily and longer,” concluded Krag.
Liver disease is on the rise and the fastest growing cause of death in the UK compared to other major killer diseases, such as heart disease and cancer, in which the number of deaths have either remained stable or decreased. It is the biggest cause of death in people aged between 35-49 years old.
If left unchecked, the annual predicted cost of NAFLD in Europe is estimated to be greater than €35 billion in direct costs to the health system, and a further €200 billion by way of wider costs to society.
Today’s official press conference highlighted four studies around NAFLD prevention and treatment selected from over 1500 abstracts being presented at ILC 2022.
The global burden of liver cancer (LC) and chronic liver diseases (CLD)
This study aimed to assess changes in the global prevalence, incidence, mortality and morbidity [disability-adjusted life-years (DALYs)] related to LC and CLD according to the etiology of CLD and 21 GBD regions of the world. Although chronic viral hepatitis B and C (CHB and CHC) and ALD have been the main drivers of burden of chronic liver disease (CLD) and liver cancer (LC), NASH has recently become more prominent. The data was obtained from the Global Burden of Disease Study 2019 (GBD 2019). Incidence, prevalence, mortality and DALYs were calculated. Annual percent change (APC) was calculated by using Joinpoint regression program, National Cancer Institute.
Zobair Younossi of the Betty and Guy Beatty Center for Integrated Research in the U.S., reported that in 2019 globally, the prevalence, incidence, mortality and DALYs from liver disease was 1.69 billion (LC 0.04% and CLD 99.96%), 2.59 million (LC 20.7% and CLD 79.3%); 1.95 million (LC 24.8% and CLD 75.3%) and 58.7 million (LC 21.3% and CLD 78.7%). Over the last decade (2009 to 2019), there was +33.7% increase in prevalence of LC and +22.7% in the prevalence of CLD. Furthermore, there was +30.0% increase in the incidence of LC and +14.8% increase in the incidence of CLD. Zobair concluded that the biggest driver of liver disease illness and mortality during the past decade (2009-2019) was NAFLD.
Abstract: The global burden of liver cancer (LC) and chronic liver diseases (CLD) is driven by non-alcoholic steatohepatitis (NASH) and alcohol liver disease (ALD) (GS008)
Session: General Session, Friday June 24, 13:40-15:40
Pemvidutide produces potent reductions in body weight and liver fat
This placebo-controlled, double-blind, first-in-human trial aimed to assess the safety and pharmaco*kinetics of Pemvidutide, a GLP-1/glucagon dual receptor agonist and to evaluate its effects on weight loss and liver fat content (LFC), both important attributes in the treatment of NASH. The drug combines the reduced caloric intake effects of GLP-1 receptor agonists with the increased energy expenditure and lipometabolic effects of glucagon receptor agonists on the liver
Scott Harris, of Altimmune in the U.S., noted that by Week 12, the 36 subjects receiving Pemvidutide achieved mean weight losses of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg**, and 2.4 mg* doses, respectively, vs. 1.6% for subjects receiving placebo (*p < .01, **p < .005 vs. placebo). Weight loss occurred rapidly and consistently across study weeks. subject plots at 1.8 mg suggested sustained effects over time. MRI-PDFF analyses following 6 weeks of treatment revealed all 5 subjects with fatty liver (≥5%) at baseline, including some as high as 19.5%, receiving 1.8 mg or 2.4 mg Pemvidutide had reductions in LFC to undetectable levels (limit of detection 1.5%), a >90% mean reduction.
Harris concluded that the rapid and potent reductions in body weight and LFC, including double-digit weight loss in 12 weeks and decreases in LFC to levels below the limit of detection, without the need for dose titration, suggest Pemvidutide could be a promising new agent for treatment of NASH and its co-morbidities.
Abstract: Pemvidutide (ALT-801), a novel GLP-1/glucagon dual receptor agonist, achieves rapid and potent reductions in body weight and liver fat: results of a placebo-controlled, double-blind, first-in-human (FIH) clinical trial (OS124)
Session: Oral Abstract Session, Saturday June 25, 17:30-19:00
Biomarkers, imaging and safety in a well-compensated NASH cirrhotic cohort treated with Resmetirom
MAESTRO-NAFLD-1 is a 52-week >1200 patient Phase 3 randomized double blind placebo controlled NASH clinical trial to study safety and biomarker effects of Resmetirom, a selective thyroid hormone receptor beta agonist, in 105 NASH patients with F1-F4 fibrosis identified using non-invasive biomarkers and imaging (NCT04197479). A goal of this “real life” NASH study is to identify non-invasive markers that correlate with individual patient response to Resmetirom treatment. The study includes an open label active Resmetirom treatment arm in well-compensated NASH cirrhotic patients.
Stephen Harrison of Pinnacle Research in the U.S., reported that Resmetirom treatment of patients with NASH cirrhosis for up to 52 weeks was safe and effective at lowering markers of CV risk and NASH fibrosis.
Abstract: Biomarkers, imaging and safety in a well-compensated NASH cirrhotic cohort treated with Resmetirom, a thyroid hormone receptor beta agonist, for 52 weeks (OS121)
Session: Oral Abstract Session, Saturday June 25, 17.30-19:00
A non-calorie restricted low carbohydrate high fat diet improves non–alcoholic fatty liver disease (NAFLD) in people with type 2 diabetes
NAFLD affects 55% of people with type 2 diabetes mellitus (T2DM), and glycaemic control predicts the severity of ballooning and fibrosis in NAFLD. Dietary interventions with low carbohydrates improve glycaemic control but the effect on NAFLD activity is unknown. This
six-month randomised controlled diet trial in 185 people aimed to investigate the effect of a six-month low-carbohydrate high fat (LCHF) diet on NAFLD assessed by ≥2 points improvement in the NAFLD Activity Score (NAS) with at least 1 point improvement in either lobular inflammation or ballooning without worsening of fibrosis and on glycaemic control.
Participants were randomised 2:1 to LCHF or to a diet consisting of high carbohydrates and low fat (HCLF). Both diets were non-calorie-restricted. The LCHF diet consisted of maximum 20 energy percent (E%) carbohydrates, 50-60E% fats and 25-30E% proteins. The HCLF diet consisted of 50-60E% carbohydrates, 20-30E% fats and 20-25E% proteins.
Camilla Dalby Hansen of Odense University Hospital in Denmark noted that liver biopsies were performed and measured HbA1c at baseline and after six months and that participants had ongoing dietitian consultations and compliance was reported continuously through an online food diary platform. Hansen concluded that a six-month non-calorie-restricted LCHF diet improves NAS and HbA1c significantly more than a HCLF diet in people with T2DM as well as bigger weight loss.
Abstract: A non-calorie restricted low carbohydrate high fat diet improves non–alcoholic fatty liver disease (NAFLD) in type 2 diabetes: a six-month randomised controlled trial (GS012)
Session: General Session, Saturday June 25, 13:40-15:40
ENDS
Further information:
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Press Programme: The Official Press Programme and instructions on how to watch the press conferences virtually can be found here:
Embargo Policy: Please note that the ILC 2022 Embargo Policy has changed this edition -media representatives are asked to familiarise themselves with the new policy.
Contact:
(In London)
Michael Kessler
Michael Kessler Media
EASL Media Relations
Email: michael.kessler@intoon-media.com
Mob: +34 655 792 699
Twitter: @mickessler
About EASL’s International Liver Congress™
This annual congress is EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research and exchange clinical experience. Attending specialists present, share, debate, and draw conclusions on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is being held entirely digitally due to the global health situation.
About the European Association for the Study of the Liver (EASL)
Since its foundation in 1966, this not-for-profit organisation has grown to over 4,800 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policy.
