Posts Tagged ‘drug development’

Progress Reported in MASH with Survodutide

February 27, 2024 — Yet another GLP-1 agonist in development for obesity – survodutide – showed promising results yesterday from a phase 2 clinical trial in MASH. In case you missed the notice, MASH is the new acronym for what we used to label as NASH. We also note that MASLD has replaced NAFLD in the nomenclature alphabet soup […]

Pfizer Hits a Speedbump with Danuglipron

December 2, 2023 — Dozens of new obesity medicines are in the pipeline for clinical development. Some folks are especially interested in oral medicines that are small molecules. They’re looking for something that offers a sharp contrast with the complex peptide molecules (like semaglutide) given by injection, which are expensive and hard to make. One of the small, orally […]

OW2023: Testing Drugs in People Like Me

October 17, 2023 — “You’re either invisible, or the answer is to lose weight, even with mental health.” This is the sentiment that surfaced at OW2023 in research of lived experiences from people coping with both obesity and needing treatment for mental health concerns. It becomes acutely important as we learn that drug trials for conditions other than obesity […]

Drug Labeling That Fails People with Obesity

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 […]

From Lukewarm to Two Billion Dollars for Bimagrumab

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 […]

A Troubling Gap: Body Size Diversity in Clinical Trials

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 […]

ADA2023: An Amazing 3-in-1 Obesity Medicine

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 […]

Will Oral Obesity Meds Match Injections?

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. […]

The Failure to Test Drugs in People with Obesity

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 […]

Tab or Jab? Oral Semaglutide for Obesity

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 […]