A phase 3 clinical 72-week trial is showing what could be a significant game-changer in the fight against obesity. Tirzepatide, a once-a-week injectable recently approved by the FDA for treating type 2 diabetes and sold under the brand name Mounjaro, was studied to see if adults without diabetes would also experience weight loss. An impressive 40% of the individuals participating in the study lost a quarter of their body weight. The study was published in The New England Journal of Medicine and was presented at the American Diabetes Association’s 82nd Scientific Sessions in New Orleans.
New hope for treating obesity
Obesity is a chronic disease worldwide that increases both morbidity and mortality. While there are options such as bariatric surgery and medications for treating obesity, these choices have limitations. Therefore, this study aimed to review the efficacy and safety of Tirzepatide in people either overweight or obese but without diabetes and to see what kind of weight loss results would occur
For this clinical trial, Eli Lilly, the study sponsor, enrolled more than 2,500 adults without type 2 diabetes who were either overweight or obese. Each enrolled person was divided into groups of receiving 5, 10, or 15 mg of Tirzepatide or a placebo each week. Results showed that individuals, who received the highest dosage of 15 mg of Tirzepatide, had an average weight loss of about 52 pounds. Those taking the 10 mg dose averaged a 49-pound weight loss and those assigned to the 5 mg group lost about 35 pounds. In contrast, individuals given the placebo lost slightly more than 5 pounds.
Other encouraging improvements besides weight loss were lowered blood sugar, blood pressure, and cholesterol levels. However, like all drugs, there are side effects, the most common being mild to moderate nausea, diarrhea, and injection site hypersensitivity reactions.
How does this new drug work?
Like all chronic diseases, the goal of treating obesity is to find safe and effective approaches that target the underlying disease mechanisms. Tirzepatide falls into a new family of medications that target two hormones – glucose-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Both hormones magnify the effectiveness of Tirzepatide by maintaining healthier blood sugar levels and sending signals from the gut to the brain, letting a person know when they are full.
Both GLP-1 and GIP play a major role in glucose regulation. Both gut hormones stimulate insulin release from the pancreas when glucose rises in response to eating food. They keep blood sugars in check and activate the satiety center in the brain, to increase a sense of fullness. In addition, these hormones slow gastric emptying and curb post-meal glucagon release, decreasing glucose spikes. This new creation of combing the GLP-1 and GIP hormones has helped significantly amplify both A1C lowering and weight loss.
The exciting news from this study is that Tirzepatide was found more effective at controlling blood sugar and inducing weight loss in patients with type 2 diabetes than Semaglutide, a weekly injectable GLP-1 receptor, and Tirezepatide also lowered hemoglobin A1C levels by dropping it 2.5% on average.
The one thing all patients should know about using any weight loss medication such as Tirezepatide is that following a calorie-lowering, healthy diet along with regular physical exercise are necessary components at driving the success of this medication.
The impressive results from this clinical trial for Tirezepatide, also has some drawbacks. Until a comparison of this drug with other weight loss treatment options, such Semaglutide and Liraglutide, another diabetes drug, it’s too early to tell if Tirezepatide is the top medication for obesity.
The trial results suggest that Tirezepatide, when used at the highest level of 15 mg weekly, appears to work as well as bariatric surgery. However, the question remains, if the FDA approves Tirezapatide for weight loss, will eligible patients embrace this new and novel approach to losing weight? It appears that cost of the medication will be a determining factor. Currently, FDA weight-loss drugs such as Wegovy or Saxenda that regulate appetite and food intake, retail for at least $1300 a month. Right now, Tirzepatide is comparable price to those medications on the market at $974.33 for four weekly doses, regardless of dose size. Unfortunately, whether a person’s health insurance will cover these costs what kind of insurance an individual has and where they live.
So, as promising as Tirezepatide sounds, the major roadblock could boil down to insurance coverage willing to cover a weight loss medication. But, perhaps health insurance companies should consider the wisdom of covering this kind of medication if it’s shown to prevent future costly complications and health risks associated with obesity.
Any person without type 2 diabetes who is overweight or obese should consult with their primary care physician about Tirezepatide, and if approved by the FDA strictly for weight loss, is it a good fit for them? Many factors will have to be considered, such as dealing with possible side effects to whether their health insurance will cover part, if not all, of the cost of this medication.
The good news is research is working toward finding an effective and safe means of helping people reach a healthy body weight. Some obese people can lose weight safely long-term by simply following a healthy diet, with the help of a registered dietitian, and exercising regularly. But many others need extra help. If this medication can be part of the plan and is affordable and safe, this could change the way we approach obesity treatment in the future.
Dr. David Samadi is the Director of Men’s Health and Urologic Oncology at St. Francis Hospital in Long Island. He’s a renowned and highly successful board certified Urologic Oncologist Expert and Robotic Surgeon in New York City, regarded as one of the leading prostate surgeons in the U.S., with a vast expertise in prostate cancer treatment and Robotic-Assisted Laparoscopic Prostatectomy. Dr. Samadi is a medical contributor to NewsMax TV and is also the author of The Ultimate MANual, Dr. Samadi’s Guide to Men’s Health and Wellness, available online both on Amazon and Barnes & Noble. Visit Dr. Samadi’s websites at robotic oncology and prostate cancer 911.