A new weight loss drug has been shown to be successful in a phase 3 clinical trial. Eli Lilly and Company’s (NYSE: LLY) tirzepatide was shown to result in weight losses between 16.0% and 22.5%. This is great news for adults with obesity or overweight, who often have difficulty losing weight through diet and exercise alone. Detailed results from the SURMOUNT-1 trial were recently published in The New England Journal of Medicine, and presented at the American Diabetes Association’s 82nd Scientific Sessions.
Could tirzepatide be the answer to permanent weight loss? This medication has been shown to help people lose weight and keep it off, even when other weight loss methods have failed. In the shared study, 73% of participants who took tirzepatide for 72 weeks achieved a 10% or greater reduction in body weight. And 50% of participants achieved a weight loss of 15% or more. That’s compared to just 6% of participants who saw those same results with placebo. It just might be the weight loss solution the world has been searching for.
In the clinical study, all three doses of tirzepatide achieved an additional secondary endpoint at 72 weeks of treatment, measuring the percentage of participants achieving at least 25% body weight reductions (not controlled for type 1 error): 16.5% (5 mg), 35% (10 mg) and 39.7% (15 mg) compared to 0.3% with placebo. Plus, participants taking tirzepatide also achieved an approximately three times greater percent reduction in fat mass versus lean mass (33.9% fat mass reduction compared to a 10.9% lean mass reduction).
Obesity is a chronic, treatable disease that affects millions of people worldwide. While there are many weight loss treatments available, many are ineffective or come with dangerous side effects. This is why the recent news about the weight loss drug tirzepatide is so exciting. In the phase 3 clinical trial, nearly 9 out of 10 participants who took tirzepatide lost weight, with some participants losing up to 20% of their body weight. These results are significantly higher than the placebo group, and suggest that tirzepatide could be a safe and effective treatment for obesity. If this drug is approved by the FDA, it could provide hope for millions of people struggling to lose weight and improve their health.
Tirzepatide-treated patients achieved significant weight loss compared to placebo, with reductions of 15%, 19.5%, and 20.9% at the 5 mg, 10 mg, and 15 mg doses, respectively. Moreover, a whopping 85%, 89%, and 91% of patients treated with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, achieved weight loss of ≥5%. These results are simply amazing and suggest that tirzepatide could be a powerful weight loss tool for those struggling to shed excess pounds. For those looking for a weight loss medication that can help them lose a significant amount of weight, tirzepatide may become a good option.
The announcement of Lilly’s weight-loss drug tirzepatide is a huge step forward in the fight against obesity. This disease has been plaguing our society for far too long, and it’s time we take a stand against it. With this new drug, we now have the potential to lose weight in a safe and effective way. This is a game-changer. This drug has the potential to change lives, and I can’t wait to see the positive impact it has on our society.
According to Eli Lilly and Company, the overall safety and tolerability profile of tirzepatide was similar to other incretin-based therapies approved for the treatment of obesity. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, usually occurring during the dose escalation period. For those treated with tirzepatide (5 mg, 10 mg and 15 mg, respectively), nausea (24.6%, 33.3%, 31.0%), diarrhea (18.7%, 21.2%, 23.0%), constipation (16.8%, 17.1%, 11.7%), and vomiting (8.3%, 10.7%, 12.2%) were more frequently experienced compared to placebo (9.5% [nausea], 7.3% [diarrhea], 5.8% [constipation], 1.7% [vomiting]). Most adverse events were resolved with continued dosing or resolved within 2 weeks after study drug discontinuation without any long-term sequelae reported. There were no clinically significant changes in electrocardiograms, vital sign measurements or clinical laboratory values observed during the course of the study that were considered to be related to tirzepatide administration. Overall, these data suggest that tirzepatide is a safe and well-tolerated therapy for the treatment of obesity in this patient population.
The study found that treatment discontinuation rates due to adverse events were 4.3% (5 mg), 7.1% (10 mg), 6.2% (15 mg) and 2.6% (placebo). The overall treatment discontinuation rates were 14.3% (5 mg), 16.4% (10 mg), 15.1% (15 mg) and 26.4% (placebo). The overall trial completion rates were 89% (5 mg), 88% (10 mg), 90% (15 mg) and 77% (placebo). These findings suggest that the medication is well-tolerated and effective in reducing the symptoms of the condition.
Eli Lilly and Company states that the SURMOUNT-1 clinical trial program is a global pivotal Phase 3 study evaluating tirzepatide, an investigational once-weekly GLP-1/glucagon receptor dual agonist. The randomized, double-blind, parallel, placebo-controlled trial is comparing the efficacy and safety of tirzepatide 5 mg, 10 mg and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who have obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. The trial randomized 2,539 participants across the United States (U.S.), Argentina, Brazil, China, India, Japan, Mexico, Russia and Taiwan in a 1:1:1:1 ratio to receive either tirzepatide 5 mg, 10 mg or 15 mg or placebo. Participants were treated for 56 weeks and followed for an additional 12 weeks after treatment. The co-primary endpoints are the change from baseline in percent weight loss at Week 56 and the change from baseline in glycosylated hemoglobin (HbA1c) levels at Week 56. Eli Lilly and Company anticipates submitting a New Drug Application to the U.S. Food and Drug Administration based on data from this study in 2023.
The U.S. Food and Drug Administration has approved tirzepatide (trade name MOUNJARO), a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Tirzepatide is the first and only once-weekly injectable medication in the GLP-1 receptor agonist class.
“The FDA approval of MOUNJARO is based on data from one of the largest clinical development programs for a type 2 diabetes medicine evaluating both short-term and long-term safety and efficacy,” said David Ricks, Lilly’s chairman and chief executive officer. “We are proud to offer this new option to the millions of Americans affected by type 2 diabetes.”
Overall, this is great news for adults with obesity or overweight, who often have difficulty losing weight through diet and exercise alone. You can read more about tirzepatide and other new weight loss drugs in our Healthy Living section.
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