August 31, 2023 — It is hard to believe. But a new commentary in Health Affairs Forefront tells us once again that drug labeling fails to assure safe and effective use for many important drugs by people with obesity. These are drugs for conditions other than obesity. But people with obesity may represent half or more of the people […]
July 15, 2023 — Four years ago, bimagrumab was a castoff from Novartis. That company had originally developed this monoclonal antibody for treating a rare muscle disease. But it failed spectacularly with disappointing results from a phase 2b study in 2016. That was a big disappointment, so it’s little wonder that Novartis walked away. Three years later, a glimmer […]
July 7, 2023 — It’s a fact. People come in all shapes and sizes. FDA and pharmaceutical researchers know this. They know that body size and composition can have large effects on how a person responds to drugs. So why do we have such a troubling gap of body size diversity in clinical trials? In the AMA Journal of […]
June 27, 2023 — The last of four big days at ADA2023 brought us astonishing results from three studies of a new obesity medicine, retatrutide. This is the first 3-in-1 metabolic receptor agonist to advance this far in clinical trials as a medicine for obesity or diabetes. Researchers presented phase 2 results for obesity, diabetes, and NAFLD – three […]
May 23, 2023 — A pair of reports on Monday raised the possibility that we may soon have oral obesity meds that match the remarkable effectiveness of injections. One of these drugs is an oral formulation of semaglutide that’s already available at a much lower oral dose for diabetes under the brand name of Rybelsus. Novo Nordisk makes it. […]
March 29, 2023 — Scientists and regulators at the FDA have identified a critical gap in new drug development and labeling. It is the failure to test new drugs in people with obesity. Where there are differences in clinical responses and safety, labeling – the instructions for safe use – should reflect those differences. But in many cases, they […]
March 27, 2023 — While Ozempic and Wegovy – two injectable forms of semaglutide – have been grabbing headlines, an oral tablet form – Rybelsus – has been quietly building momentum. Right now, it’s only approved for use in type 2 diabetes. But on Friday, Novo Nordisk announced results from the first phase 3 study of oral semaglutide for […]
November 2, 2021 — Monday was quite an opening day for ObesityWeek 2021. Starting with the lived experience, the meeting then moved quickly into some serious science, clinical care, and policy discussions. But one of the most impressive sessions of the day gave us a “tour de force” of future options under development for obesity care. Our friend Mike […]
October 20, 2021 — Day by day, the prospects for treating obesity are getting better. Late on Monday, detailed results from the longest study yet of tirzepatide came out in Lancet. This was a study using this new drug in people with type 2 diabetes, but the average BMI of these patients was 33. None of them had a […]
September 27, 2021 — It was an exciting possibility. At ObesityWeek 2019, Novartis scientist Laura Coleman presented fascinating results for an experimental drug, bimagumide, in obesity. In a phase 2 study, it yielded impressive improvements in body composition for people with obesity. It wasn’t just making people lose body fat. It helped them also gain muscle mass. Then, it […]
