Eli Lilly And Co LLY announced the detailed results from the SURMOUNT-4 Phase 3 study evaluating the safety and efficacy of Zepbound (tirzepatide) compared to a placebo for obesity with weight-related comorbidities, excluding type 2 diabetes.
Zepbound met the primary endpoint of mean percent change in body weight and all key secondary endpoints for both estimands, compared to placebo 52 weeks after randomization.
Zepbound injection is FDA-approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.
After 36 weeks of open-label Zepbound, participants, who would then go on to be randomized to Zepbound or placebo in the double-blind period, experienced a mean weight reduction of 20.9% from a mean body weight of 236.6 lb. (107.3 kg) at the study entry.
Additional secondary endpoints showed that Zepbound was also associated with improved BMI, fasting insulin, lipids, blood pressure, and health-related quality of life.
During the Zepbound lead-in treatment period, the most frequent adverse events were nausea (35.5%), diarrhea (21.1%), constipation (20.7%), and vomiting (16.3%).
The researchers concluded that in participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.
Price Action: LLY shares are down 4.74% at $569.73 on the last check Monday.
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