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Eli Lilly took a major step forward in the GLP-1 arms race with positive data supporting its obesity pill.

On Tuesday morning, the pharma giant announced that its oral GLP-1 drug orforglipron successfully met all the key primary and secondary endpoints set for the drug in a Phase 3 trial. 

In a statement, Lilly confirmed that the treatment delivered significant weight loss, meaningful A1C reductions and improvements in cardiometabolic risk factors at 72 weeks. 

The trial tested different doses of orforglipron — including 6mg, 12mg and 36mg — against a placebo. The highest dosage of the drug resulted in an average of 10.5% reduction in weight (22.9 pounds) compared to the 2.2% reduction in weight in the placebo. 

The 12mg version of the drug showed an average of 7.8% reduction (17.4lbs) and the 6mg version achieved a 5.5% reduction (12.1bs) in weight. 

Half of those tested as part of the 36mg group achieved body weight reduction of more than 10%, compared to the 7% of participants achieving the same threshold for the placebo group. 

The pill also helped type 2 diabetes patients lower their hemoglobin A1C, a measure of the blood sugar levels. 

Three-quarters of the trial’s participants taking the highest dosage of orforglipron no longer met the criteria for type 2 diabetes defined by the American Diabetes Association. 

In an email statement to MM+M, Lilly noted that the treatment reduced A1C by an average of 1.8%. 

While existing GLP-1 medications have shown greater weight loss than Eli Lilly’s oral medication, the oral option targets both weight loss and type 2 diabetes in patients. 

The company also said that the treatment showed “clinically meaningful benefits” across key cardiovascular risk factors, which include non-HDL cholesterol, systolic blood pressure and triglycerides. 

The treatment was also shown to significantly reduce inflammation. The 36mg dose of orforglipron reduced high-sensitivity C-reative protein — a marker of inflammation — by 50.6%. 

Kenneth Custer, Lilly’s EVP and president of Lilly Cardiometabolic Health, said in a statement that the team plans to move forward with global regulatory submissions of the treatment. 

“If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally — removing barriers and redefining how obesity is treated around the world,” he said. 

The oral treatment also differs from injectible GLP-1 as they have different mechanisms and formulas. 

Lilly said in an email that while both target metabolic disease, tirzepatide is a GIP/GLP-1 dual agonist injectable, whereas orforglipron is a selective, oral GLP-1 receptor agonist.

The company added that orforglipron is “meant to complement, rather than replace Lilly’s existing portfolio.” The drugmaker also said that it is meant to be an “easy-to-use oral option with no water or food restrictions.”

The data readout came three weeks after Lilly said the highest dose of its daily obesity pill helped patients lose almost 12% of their body weight — which was less than analyst expectations of 15%.

Yet in April, Lilly offered a glimpse at orforglipron — noting that its oral GLP-1 drug demonstrated significant efficacy results and a safety profile consistent with its other GLP-1 products.

Despite the successful trial, 10.6% of participants discontinued the 36mg and 12mg treatment due to adverse effects, compared to 4.6% in the placebo group. 

Like injectable GLP-1s, the most commonly reported adverse events were gastrointestinal related, and were generally mild to moderate in severity. 

An estimated 23.1% of those who took the highest dose of the drug experienced vomiting, while 36.4% experienced nausea and 27.4% experience diarrhea. 

If approved by global regulatory bodies, Lilly said that it is ready to offer a convenient, once-daily pill that can be scaled globally next year.