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An oral weight loss pill has performed well in clinical trials, positioning it as a potential alternative to injectable GLP-1 medications like Ozempic and Wegovy.
The Eli Lilly drug, called orforglipron, demonstrated “meaningful weight loss” and cardiometabolic improvements, according to a press release.
The phase 3 ATTAIN-1 trial, which was published in the New England Journal of Medicine, evaluated the safety and efficacy of the drug in adults who have a weight-related medical problem and do not have diabetes.
The participants underwent 72 weeks of treatment with three different doses (6 mg, 12 mg and 36 mg).
After the trial period, results showed that orforglipron met the “primary endpoint of superior body weight reduction” compared to a placebo.
Those who took the highest dose lost an average of 27.3 pounds. Nearly 60% of these participants lost 10% of their body weight, while 39.6% lost at least 15%.
Of the 1,127 participants who had pre-diabetes at the start of the study, up to 91% achieved nearly normal blood sugar levels compared to the 42% taking a placebo, the researchers found.
Orforglipron showed “clinically meaningful improvements” in cardiovascular risk factors associated with obesity, like non-HDL cholesterol, systolic blood pressure and triglycerides.
The highest dose also reduced a marker for inflammation, called high-sensitivity C-reactive protein, by 47.7%.
The study found the drug’s safety profile to be consistent with the existing GLP-1 medications. The most common side effects were gastrointestinal, including nausea, constipation, diarrhea and vomiting, at mild to moderate severity.
Sean Wharton, M.D., director at Wharton Medical Clinic and the lead study author in Canada, wrote in a statement that obesity is a “complex, global health challenge” requiring treatment options that are “effective and easy to integrate into everyday life.”
“In this phase 3 study, orforglipron demonstrated strong efficacy results and safety consistent with the GLP-1 class, reinforcing its potential as a first-line treatment in primary care,” he said in the press release.
“Orforglipron could help reduce known markers of cardiovascular risk associated with obesity and support meaningful improvements in public health.”
Lilly announced it is moving forward with plans to get approval for orforglipron as an obesity drug. The company expects it could get the green light as early as 2026. In the same year, it also plans to apply for approval to use the drug for type 2 diabetes treatment.
Reuters reported that this pill could be “fast-tracked” under a one- to two-month review process launched by the Food and Drug Administration, according to Wall Street analysts.
“Analysts speculate that the drug, orforglipron, is a viable candidate given the growing cost burden of expensive injectable weight-loss drugs and the fact that Lilly is expanding its U.S. manufacturing – issues the Trump administration has prioritized,” Reuters wrote.
In an interview with Fox News Digital, Sue Decotiis, M.D., medical weight loss doctor in New York City, called this drug a “positive addition to the armamentarium” that’s cheaper to produce and less expensive for the consumer.
Decotiis noted, however, that the weight loss results are “not as impressive” as the results from injectables like Ozempic and Mounjaro.
“However, compliance with orforglipron may be better, as it is an oral medication and not an injectable,” she said.
One concern with this new drug, according to Decotiis, is that it is not a peptide, which has a high safety factor and is “easy for the body to metabolize and adjust to.”
“There could be unknown long-term consequences that we have yet to know about,” she added. “I believe there will be more oral weight loss drugs in the pipeline and hope they will be in the peptide category.”
Fox News Digital reached out to Eli Lilly for comment.
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