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This publication reports a 12-week, randomized, double-blind, placebo-controlled Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of eloralintide. The study enrolled 100 overweight or obese participants with an average age of 44 years, 29% of whom were female, and a body mass index (BMI) ranging from 27 to 43 kg/m². Participants were randomly assigned to one of five groups receiving either placebo or multiple ascending doses of eloralintide.
The results showed that the mean half-life of eloralintide was 13.9 to 15.8 days. The most common adverse events in the drug group were decreased appetite (19%), headache (12%), fatigue (11%), and COVID-19 infection (11%), while gastrointestinal...The incidence of gastrointestinal-related adverse events was low, including diarrhea (10%), nausea (8%), and vomiting (4%). Most adverse events were mild, no deaths were observed, and one serious adverse event was unrelated to eloralintide.
In terms of efficacy, at week 12, the least squares mean percentage change in body weight in the eloralintide group ranged from a decrease of 2.6% to 11.3%, while patients in the placebo group experienced a 0.2% increase in body weight. The results demonstrate clear weight-loss potential and support the further development of eloralintide, with its safety and efficacy to be further validated in Phase 2 clinical trials.
Eloralintide is a once-weekly subcutaneous injectable selective long-acting amylin receptor agonist, demonstrating good tolerability and clear weight loss effects.EloralintideUnlike other amylin agonists, its design goal is to minimize calcitonin-related activity in clinical settings.
About Eli Lilly and Company
Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, manufacturing, and marketing of medicines, dedicated to improving human health through innovation. Eli Lilly and Company was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876. The company's founder was committed to producing high-quality medicines to meet genuine medical needs.