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INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a pharmaceutical giant with a market capitalization of $670 billion and impressive sales growth of 36.38% over the past 12 months, announced Thursday that its investigational drug orforglipron, a once-daily oral GLP-1 receptor agonist, has achieved significant weight loss in adults with obesity or overweight and related health conditions. Data from InvestingPro the company has robust financial health and operates with industry-leading gross profit margins of 81.7%.
In the Phase 3 ATTAIN-1 study with 3,127 participants, the highest dose (36 mg) of orforglipron resulted in an average weight loss of 12.4% (27.3 pounds) after 72 weeks of treatment compared to 0.9% (2.2 pounds) in the placebo group. This met the primary endpoint of the study. This development has attracted the attention of analysts. According to InvestingPro eight analysts have revised their earnings forecasts upwards for the coming period. For deeper insights into Eli Lilly and Company's growth potential and a comprehensive analysis, investors can view the detailed Pro Research Report, available exclusively to InvestingPro subscribers.
The study also showed that 59.6% of participants receiving the highest dose lost at least 10% of their body weight, while 39.6% experienced at least 15% weight loss. Treatment was associated with a reduction in cardiovascular risk markers, including non-HDL cholesterol, triglycerides and systolic blood pressure.
"With orforglipron, we are working to revolutionize the treatment of obesity by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management," Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said in the press release.
The most common adverse events were gastrointestinal in nature and included nausea, constipation, diarrhea, vomiting and dyspepsia, which is consistent with the GLP-1 receptor agonist drug class. Treatment discontinuation rates due to adverse events ranged from 5.1% to 10.3% depending on orforglipron dose, compared to 2.6% in the placebo group.
Orforglipron can be taken at any time of day regardless of meal or fluid intake, potentially offering a more convenient alternative to injectable GLP-1 therapies.
Lilly plans to submit orforglipron for regulatory review by the end of the year and is preparing for a global launch. Detailed results of the ATTAIN-1 study will be presented next month at the annual meeting of the European Association for the Study of Diabetes. According to the calculations of InvestingPro The company is trading close to its fair value and has a strong consensus analyst rating of 1.72 (where 1 stands for "Strong Buy"). Investors looking for detailed valuation metrics and additional ProTips can find a comprehensive analysis in the Pro Research Report.
The company is also evaluating orforgliprone for the treatment of type 2 diabetes, obstructive sleep apnea and hypertension in adults with obesity.
In other recent news, Eli Lilly and Company has made significant progress with its diabetes drug Mounjaro (tirzepatide). In a study, it showed favorable cardiovascular outcomes compared to Trulicity in patients with type 2 diabetes and cardiovascular disease. The study showed an 8% lower rate of serious adverse cardiovascular events and a 16% lower all-cause mortality in patients treated with Mounjaro. In addition, Eli Lilly's Alzheimer's drug Kisunla (donanemab) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, paving the way for possible approval in Europe. In the field of oncology, the company's BTK inhibitor Jaypirca (pirtobrutinib) showed positive results in a study on chronic lymphocytic leukemia, demonstrating non-inferiority compared to Imbruvica. Analyst firms are taking note of these developments. For example, BMO Capital raised its price target on Eli Lilly and Company to $920 and maintained an Outperform rating based on confidence in the company's pipeline, including orforgliprone. Bernstein SocGen Group also reiterated its "Outperform" rating with a price target of USD 1,100, influenced by the potential coverage of weight loss drugs by Medicare. This progress reflects Eli Lilly and Company's continued efforts to expand its therapeutic offerings across multiple disease areas.
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