- An experimental weight-loss drug is making headlines after people lost more than 20% of their body weight in trials.
- The drug has not yet been approved by the FDA.
- Experts say the results are exciting, but it probably won’t be a silver bullet to ending obesity.
Participants in a clinical trial lost more than 50 pounds on average when treated with the highest dose of a new appetite suppressant, according to to pharmacist Eli Lilly.
While the drug called tirzepatide has grabbed the headlines, it’s important to note that it’s still experimental and has not been approved or cleared by the Food and Drug Administration. Additionally, the initial research was made public by drugmaker Eli Lilly and has yet to be published in a peer-reviewed medical journal.
Although it’s still early days, some medical experts say new treatments are needed to treat obesity.
“Obesity is a chronic disease that often does not receive the same level of care as other conditions, despite its impact on physical, psychological and metabolic health, which can include an increased risk of hypertension, heart disease, cancer and decreased survival,” said the study investigator. Louis J. Aronne, MD, of Weill Cornell Medicine in New York, said in a statement.
Phase III of 72 weeks SURMOUNT-1 clinical trial found that people taking 15 mg of a once-weekly injectable drug called tirzepatide lost 22.5% of their body weight — for an average weight loss in participants of 52 pounds.
According to Eli Lilly, the trial was a multi-center, double-blind, placebo study with 2,539 participants. The researchers compared the efficacy and safety of tirzepatide at different doses to a placebo.
The trial participants, who weighed an average of 230 pounds at the start of the trial, self-injected tirzepatide once a week in varying doses or a placebo.
People in the study were obese and had at least one comorbidity, including high blood pressure, obstructive sleep apnea or cardiovascular disease. No one had type 2 diabetes.
A low-calorie diet and increased physical activity were followed by all participants during the 72-week study period.
The results indicate that the highest dose was the most effective, resulting in an average weight loss of over 50 pounds, or an average weight reduction of almost 23%.
However, participants injecting the placebo only lost about five pounds on average, even though they also cut calories and increased exercise.
Commonly reported adverse events included nausea, constipation and diarrhea. They were generally mild to moderate in intensity and usually occurred when the dose was increased.
“The data from Tirzepatide look impressive and highlight a new class of drugs that are very effective in treating obesity,” said Dr. W. Scott ButschMD, director of obesity medicine at the Bariatric and Metabolic Institute at the Cleveland Clinic.
Butsch added that it is the first drug to produce an average weight loss of 20%.
“Which is twice as much as current obesity drugs outside of this class,” he said.
“Having a very effective medical treatment is an important step in treating the disease of obesity and helping our patients who generally think that if a lifestyle change doesn’t work, bariatric surgery is the only option,” Butsch continued.
Although this drug made headlines for its initial discoveries, Jeffrey G. DyoMD, internal medicine at UCI Health in Irvine, Calif., said it likely won’t be a simple solution for people looking to maintain their weight permanently.
Dyo thinks people taking tirzepatide may need to continue using the drug to maintain weight loss.
“Obesity is considered a chronic medical condition and can persist or relapse for months or even years,” he said.
However, he pointed out that studies with similar weight-loss drugs suggest that stopping use can lead to regaining lost weight.
“The duration of treatment indefinitely or long-term has not yet been specifically studied in tirzepatide,” he said.
Dyo noted that some people may be able to maintain their weight once they reach their goal.
Shailendra PatelMD, PhD, Division of Endocrinology, Diabetes, and Metabolism at the University of Cincinnati College of Medicine, told Healthline that approaches to weight loss typically involve dieting, but dieting often only results in a short-term weight loss as they are extremely difficult to adhere to. with for an indefinite period.
“The reason all of these diets fail is that human beings can’t stick to one of these diets forever,” he said.
The reasons for obesity and why it is difficult to lose weight are complex. Certain hormones or health conditions can lead to weight gain in addition to a lack of healthy food options.
Patel points out that due to the complexity of obesity, relying on a single solution, whether it’s a diet or a pill, is unlikely to work in the long term.
“We have yet another weight loss drug to help patients,” Patel said. “But the drugs themselves, just like the crash diets themselves, you can see weight loss – but you won’t be successful.”
He said if obese people want to lose weight, it may require several interventions, some of which may include medical interventions.
Patel pointed out that even
Results from recent clinical trials show that once a week tirzepatide, an injectable drug, can help people lose significant amounts of weight.
It has not yet been approved by the FDA and the data has not yet been published in a peer-reviewed journal.
Experts say obesity is a chronic condition with underlying biological processes and people may need to take the drug long-term to maintain their weight. They also say that regardless of the method used, successful long-term weight loss can include both medication and lifestyle changes.