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  • Dr. Paul S. Bradley, MD

Inside the GLP-1 Clinical Trials: What Plan Sponsors Need to Know



Around 20 years ago, I led a research trial using the antidepressant Wellbutrin to try and cause weight loss in healthy volunteers. The history behind that early trial was simple: in using Wellbutrin in my Internal Medicine practice to treat depressed patients, I found that those same patients were seeing significant weight loss. I presented my findings at the time at the annual meeting of the American Psychiatric Association.


Simultaneously, another researcher presented a study using the same Wellbutrin as an aide to quit smoking. I remember at the time being interviewed by a reporter for The Wall Street Journal who made the quip, “Doctor you are saying this is a miracle drug that does everything!”


I tried explaining that’s not what I had said, but that it did have very interesting properties with significant promise. That prompted a large amount of Wellbutrin being sold and a lot more studies. The end result was Wellbutrin was found to be helpful as an adjunct to losing weight, but not a miracle. Flash to the present though and the GLP-1 class is starting to take on a miracle persona.


Much like the Wellbutrin that came on the market for one condition and eventually was used for other problems, the GLP-1 class has done the same. Originally for diabetes, it slowly became obvious that this class caused weight loss in a high percentage of those patients. As the drug has been refined, we are finding more and more positive effects. In our diabetic patients, we are seeing significant and often dramatic improvements in glucose control. Ironically most of our diabetic medications before the GLP-1 class caused weight gain. Finally, we have a diabetic medication that not only lowers blood sugar but also helps address the root of the problem by decreasing appetite and causing weight loss.


But it does not stop there: The FDA mandates that all diabetic medications have dedicated trials solely for the purpose of proving cardiac safety. When we looked at Ozempic and subsequently the weight loss version, Wegovy, we found not only an excellent safety profile in general, but also cardiac improvement – meaning that patients with weak hearts were seeing improving cardiac function over and above what we see just from weight loss. This finding was so striking that Wegovy is now indicated for overweight and obese patients with heart disease. Medicare has already started financial coverage for its members.


But it also doesn’t stop there: Similar studies in patients with chronic kidney disease are showing improved renal function. And if all that was not enough of a miracle, studies are looking at using the class to treat Alzheimer’s disease, fatty liver disease, addictive states, and peripheral vascular disease to name a few. There are multiple GLP-1s in development by multiple companies. It really does feel like a miracle when one walks out of an exam room, having just seen a patient who never seemed to lose any weight now report a hundred-plus pound improvement!


 

Scripta Tips for Plan Sponsors


  1. Provide transparency into all the available patient options for these drugs.

  2. Ensure your actuarial consultant is applying these additional indications into your self-funded plan budget forecasting. Saying, “we don’t cover weight loss meds” won’t get your plan off the hook with the high costs of these therapies.

  3. Have a successful bridge-program to wean patients off these drugs while maintaining their weight and healthy lifestyle.

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