Posts Tagged ‘clinical trials’

It’s entertaining in a perverse way. Cluelessness about the potential of orforglipron is impossible to miss in the news about Lilly’s new oral GLP-1 medicine for obesity this month. The company announced topline results from the first of two pivotal studies for this medicine on August 7 and investors decided the drug was a dud. […]

Only a little more than a month ago, Novo Nordisk told Reuters that yes, they really did expect their next generation obesity drug, CagriSema, to deliver 25% weight loss in clinical trials. Then Thursday, the company disclosed topline results of 23% weight loss. Almost immediately, company’s stock price plunged by more than 20% – a […]

FDA is working hard to push drug companies to get more diversity into the clinical trials that are the foundation for bringing new, safe, and effective drugs into the market. In June, the agency issued guidance for diversity action plans to improve the representation of marginalized populations. But unfortunately, it has nothing to say about […]

The American College of Clinical Pharmacology is meeting in Bethesda this week. On the opening day, ACCP convened a symposium to address critical questions about how drugs work in people with obesity. What can we – industry, FDA, and scientists – do better? Because all too often, drug labels to guide safe prescribing are effectively […]

The calls are growing louder and more frequent to include people living with obesity in clinical trials and drug labels. Of course trials and labels for drugs that treat obesity include these patients. But the huge problem is that for everything else, more often than not, drug studies and labels exclude them. Now, the American […]

FDA has a bone to pick with Otsuka, the company that sells Rexulti (brexpiprazole). The agency is taking issue with false advertising by the company for this drug used in schizophrenia and severe depression. To us, this problem of inflated efficacy claims is especially noteworthy because, for people with obesity who may need this drug, […]

For some time to come, we will be learning more and more about the details and implications of the landmark SELECT study published yesterday in NEJM and presented at the American Heart Association Scientific Sessions in Philadelphia. A massive crowd packed the meeting hall yesterday for good reason. These results will change the practice of […]

Public health experts have long been accounting for it. People are living in larger bodies. Better than 40% of U.S. adults have a body weight in the range of obesity. But new reporting from JoNel Aleccia for the Associated Press tells us that pharma and the FDA are not yet accounting for this fact. It’s […]

“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 […]

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 […]