Boehringer Ingelheim could soon stake a claim in the lucrative obesity treatment market after the pharma company said it has advanced a candidate into three Phase III trials following promising data. Survodutide, the company’s glucagon/glucagon-like peptide 1 (GLP-1) receptor dual agonist co-developed with Zealand Pharma, demonstrated up to 19% weight loss after 46 weeks of treatment in a Phase II dose escalation trial investigating the drug in patients living with obesity without type 2 diabetes (T2D). In a statement announcing the plans, Boehringer Ingelheim said that insights from previous studies will be used to inform the design of the three Phase III trials which will investigate the efficacy and safety of survodutide. Enrolment of patients is planned before the end of 2023, with the company saying that study details will be unveiled nearer to trial commencement. Survodutide has previously received a US Food and Drug Administration (FDA) fast track designation ...
Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects up to 30% of adults in the general population. It is characterized by the accumulation of fat in the liver. It is often associated with other conditions, such as obesity, type 2 diabetes, and metabolic syndrome. The new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed in 2020. MAFLD is diagnosed based on hepatic steatosis (fatty liver) and at least one of three metabolic risk abnormalities: overweight/obesity, type 2 diabetes, or evidence of metabolic dysregulation. A recent meta-analysis led by Ming-Hua Zheng from the First Affiliated Hospital of Wenzhou Medical University has reported a global prevalence of MAFLD of 38.8% in adults. MAFLD can progress to cirrhosis and promote the development of some critical extrahepatic diseases, such as cardiovascular disease and chronic kidney disease. MAFLD is a severe condition that can lead to cirrhosis and other health ...
Amongst fierce competition in the obesity space, Novo Nordisk has spent $1bn to acquire Inversago Pharma to shore up its weight loss treatment portfolio. The acquisition is expected to be completed by the end of 2023 and will hit the billion-dollar mark, subject to developmental and commercial milestones. The deal, which comes a month after Eli Lilly acquired Versanis and its lead weight loss candidate, bimagrumab, in a $1.9bn deal, will include Inversago’s lead asset INV-202, an oral cannabinoid receptor type-1 (CB1) inverse agonist. Novo Nordisk said it intends to use the candidate for patients with obesity and obesity-related complications. Canada-based Inversago demonstrated the weight loss potential of the candidate in a Phase Ia trial by blocking the CB1 receptor, which plays an important role in appetite regulation and metabolism. INV-202 is currently in a Phase II trial for diabetic kidney disease (NCT05514548). Prior to the 10 August announcement, Novo ...
Novo Nordisk’s blockbuster weight loss injection Wegovy could prevent up to 1.5 million heart attacks, strokes and other cardiovascular events in the U.S. over 10 years, according to a study released this week. Researchers from the University of California, Irvine, also found that Wegovy could result in 43 million fewer Americans with obesity over a decade. Notably, the study was partly funded by Novo Nordisk. The study results complement the initial data the Danish company released last week from a large clinical trial, which found that Wegovy slashed the risk of serious heart problems and heart-related death by 20%. Novo Nordisk’s trial studied overweight or obese patients with established cardiovascular disease, while UC Irvine’s study examined similar patients, albeit without the disease. Together, the results suggest that Wegovy and, likely, similar obesity drugs have significant health benefits beyond shedding unwanted pounds. Physicians and Wall Street analysts hope that could eventually ...
By Meg Tirrell, CNN The weight loss drug Wegovy was shown to reduce the risk of heart attack, stroke or heart-related death by 20% in what’s being called a landmark clinical trial in people with cardiovascular disease, the first to show a weight loss drug alone can have such protective effects. Novo Nordisk studied Wegovy against placebo in addition to standard of care for prevention of major adverse cardiac events in 17,604 adults with heart disease and obesity or who were overweight, but who didn’t have diabetes. It called the five-year trial “Select.” The finding of a 20% reduction in heart risk is higher than many experts had anticipated. A similar trial for the type 2 diabetes drug Ozempic, which uses the same ingredient, semaglutide, previously showed it could reduce cardiovascular risk by 26% — but no trial had yet shown a risk reduction in people without diabetes. “Historically, trials ...
By Tristan Manalac Novo Nordisk’s weight-loss medication Wegovy (semaglutide) met its primary efficacy endpoint in the Phase III SELECT trial, demonstrating strong protective effect on cardiovascular health in overweight and obese adults without diabetes, the company announced Tuesday. At a 2.4-mg dose level, once-weekly Wegovy injections significantly reduced the occurrence of major adverse cardiovascular events (MACE) by 20% as compared with placebo. This treatment effect was statistically significant, according to Novo’s announcement. Wegovy’s safety profile in SELECT was also in line with what had been established in previous studies. SELECT defined MACE as a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Wegovy reduced the frequency of all three MACE components in SELECT. Novo was trading approximately 11% higher in pre-market Tuesday following the data drop. The results from SELECT highlight the potential dual benefits of Wegovy for overweight and obese adults who suffer from a heightened risk ...
Published in the International Journal of Obesity, University of Minnesota Medical School and School of Public Health researchers led a study on the relationship between dietary intake and cardiovascular disease risk factors. Over 20 years, the research team examined people’s regular dietary intake, paying particular attention to non-nutritive sweeteners commonly found in artificial sweeteners. They found that long-term consumption of aspartame, saccharin, and diet beverages were linked to increased fat stores in the abdomen and fat within muscle. However, the study found no significant association between the artificial sweetener sucralose and these measures of fat volume. Brian Steffen (PhD, MSCR, Professor, Department of Surgery, University of Minnesota Medical School) said, “This study showed that habitual, long-term intake of total and individual artificial sweetener intakes are related to greater volumes of adipose tissue, commonly known as body fat. This was found even after accounting for other factors, including how much a ...
As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. Case in point is a claim from a Louisiana woman who is suing both companies, alleging her use of Novo’s Ozempic (semaglutide) and Lilly’s Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, who used Ozempic for more than a year and then switched to Mounjaro, says the companies failed to warn patients of “severe gastrointestinal events” that can be caused by using the injected drugs. The lawsuit claims that Bjorklund has suffered from “severe vomiting, stomach pain, gastrointestinal burning,” and has been hospitalized for stomach issues on “several” occasions. The prescribing labels for Ozempic and Mounjaro say the drugs “delay gastric emptying” and warn of the risk of gastrointestinal adverse ...
The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients. The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review. Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement. The MHRA review kicked off July 12, though the agency could not specify when it would ...
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