CLEVELAND — Cleveland Clinic cardiologist, Steven Nissen, MD, rarely minces words.
"We are really entering a completely new era now, where for the first time, we have drugs for obesity that actually work," he said.
Eli Lilly's tirzepatide, sold as Mounjaro, is FDA-approved to treat type 2 diabetes. Now it's asking the FDA to fast track it as a weight loss drug.
When tested on non-diabetics, results were more than impressive.
"It showed more than a 20% average weight loss over 18 months This is in the range of weight loss that we only saw with bariatric surgery," Nissen said.
The diabetic group lost nearly 16% percent. Results slightly better than Wegovy and Ozempic, and the same kind of weekly injection.
Nissen is leading a global study of the drug for another reason. Some 15,000 patients with obesity will either get Mounjaro or a placebo, plus counseling.
Nissen wants to know if there's another benefit.
"There's a very good chance that losing as much body weight as people will lose with this drug will actually reduce cardiovascular events," he said.
These drugs mimic a hormone that reduces appetite by signaling the brain to make the stomach feel fuller. However, if the medication is stopped, the weight will likely return.
"When someone gets their blood pressure under control, we don't take them off the medication. When someone gets their cholesterol under control, we don't take them off the medication, because if you stop them, the problems return. We need to think about treating obesity as a chronic disease," Nissen said.
The National Institutes of Health declared obesity a disease in 1998. The American Obesity Society did so in 2008. The American Medical Association (AMA) officially recognized obesity as a chronic disease in 2013.
Many think obesity is simply a case of lack of willpower. Studies have shown some cases of obesity may be genetic, meaning diet and exercise won't work.
According to Harvard Health, genes may be to blame if you fit the following:
- You have been overweight for much of your life.
- One or both of your parents or several other blood relatives are significantly overweight. If both of your parents have obesity, your likelihood of developing obesity is as high as 80%.
- You can't lose weight even when you increase your physical activity and stick to a low-calorie diet for many months.
Other factors may be to blame if:
- You are strongly influenced by the availability of food.
- You are moderately overweight, but you can lose weight when you follow a reasonable diet and exercise program.
- You regain lost weight during the holiday season, after changing your eating or exercise habits, or at times when you experience psychological or social problems.
As for Mounjaro, side effects are similar to Wegovy and Ozempic and include nausea and constipation. Nissen expects Mounjaro to be approved for weight loss by the end of the year.
"This is a revolution. I mean we have been struggling for decades in coming up with effective therapies for patients with obesity and this is a breakthrough. To have drugs that are this effective in helping people to lose weight, in my opinion, is very likely to save a lot of lives," Nissen said.
If the FDA does sign off on it as a weight loss drug, it will likely be priced as high as the other drugs, meaning well over $1,000.
Nissen’s study, called Surmount-MMO, is enrolling patients with obesity at more than 700 locations in 27 different countries. Results may take years. At this time there is just one location in Ohio: Aventiv Research in Columbus. 614-501-6164.
To learn more about the study click HERE.