LLY Stock Up as Oral GLP-1 Pill Meets Goals in First Phase III Study
Shares of Eli Lilly LLY soared 14.3% on April 17 after data from a late-stage study showed that orforglipron achieved the primary goal of significantly reducing A1C levels compared to placebo at 40 weeks, with an average A1C reduction of 1.3% to 1.6% from a baseline of 8%. LLY's orforglipron is an investigational, once-daily small-molecule oral GLP-1 receptor agonist that can be administered at any time of the day without restrictions on food and water intake.
The phase III ACHIEVE-1 study, the first of seven late-stage studies, is evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes (T2D) and inadequate glycemic control with diet and exercise alone. The enrolled patients in the 40-week study were randomized equally to receive either a 3 mg, 12 mg or 36 mg dose of orforglipron or placebo. Lilly is also developing a version of this oral drug for obesity.
The candidate also met the key secondary endpoint in the ACHIEVE-1 study, as more than 65% of the patients receiving the highest dose of orforglipron reached A1C levels of 6.5% or lower — the threshold used by the American Diabetes Association to define diabetes. Additionally, patients taking the highest 36 mg dose lost an average of 16 pounds, which translates to 7.9% of their total body weight, another key secondary endpoint. Interestingly, weight loss was still ongoing when the study concluded. This suggests that a higher weight loss percentage may be observed with the candidate over a longer treatment duration.
Year to date, shares of Lilly have gained 8.8% against the industry's 3.3% decline.
Image Source: Zacks Investment Research
Additionally, analysis of the phase III study data, regardless of treatment adherence, showed that patients receiving orforglipron achieved statistically significant reductions in A1C across all doses, with the 12 mg and 36 mg doses also showing statistically significant weight loss.
The overall safety profile of orforglipron in the ACHIEVE-1 study aligned with that of other GLP-1 therapies. Side effects were typically mild to moderate in intensity. The highest rate of treatment discontinuation due to adverse events (8%) was observed in the patient cohort receiving the 36 mg dose of orforglipron.
Lilly in-licensed the candidate from Chugai Pharmaceutical in 2018. Apart from the T2D and obesity indications, orforglipron is also being explored as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity.
Lilly expects to report additional results from the phase III ACHIEVE clinical program, as well as data readout from the phase III ATTAIN clinical program evaluating orforglipron for weight management, later this year. It plans to submit applications to global regulatory authorities seeking the approval of orforglipron for weight management by the end of this year. Submission of regulatory applications seeking the approval of the candidate for T2D is expected in 2026.
Eli Lilly and Novo Nordisk NVO currently dominate the diabetes and obesity-care market on the back of the tremendous success of their GLP-1 injections. Lilly markets its dual GIP and GLP-1 receptor agonist, tirzepatide, as Mounjaro for T2D and Zepbound for obesity, while Novo Nordisk markets its semaglutide drugs as Ozempic for T2D and Wegovy for weight management. NVO also markets Rybelsus as an oral medication for adults with T2D to control blood sugar levels, but unlike orforglipron, Rybelsus therapy has restrictions on food and water intake.
Lilly's recent phase III ACHIEVE-1 success reinforces its frontrunner status in the race to develop an oral diabetes/obesity therapy. In response to LLY's successful study data, NVO's stock lost 7.6% in the last trading session. Oral medications, being more convenient than injectables, tend to boost patient adherence. Novo Nordisk is developing its oral obesity pill, amycretin, in a mid-stage study. Amycretin is a dual receptor agonist that targets two key gut hormones, GLP-1 and amylin.
Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote
Lilly's first phase III success for orforglipron has also confirmed the potential efficacy of oral pills for weight management, which, if approved, would be preferred over injectable options. This likely resulted in the stock price gains of Structure Therapeutics GPCR and Viking Therapeutics VKTX, which are currently developing oral GLP-1-based obesity candidates in their pipeline in mid-stage studies.
Shares of Structure Therapeuticssoared 17.4% following LLY's news. GPCR is conducting multiple mid-stage studies on its lead candidate, aleniglipron (GSBR-1290), a highly selective oral GLP-1 receptor agonist, for treating healthy overweight or obese individuals.
On the other hand, shares of Viking Therapeutics gained 1.4%.VKTX is currently evaluating the safety and efficacy of the oral formulation of its experimental obesity drug, VK2735, in a mid-stage study. Last month, Viking Therapeutics reported that it has completed enrollment in the phase II VENTURE-Oral Dosing study of the candidate for the obesity indication. Data from this study is expected in the second half of 2025.
The rapid advancements being made by Viking Therapeutics and Structure Therapeutics in the development of their respective oral obesity treatment candidates have made them lucrative targets for collaboration or M&A deals.
Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 (Strong Buy) Rank stocks here.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Novo Nordisk A/S (NVO) : Free Stock Analysis Report
Eli Lilly and Company (LLY) : Free Stock Analysis Report
Viking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report
Structure Therapeutics Inc. Sponsored ADR (GPCR) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
6 hours ago
- Business Insider
Eli Lilly's obesity drug sales rise in India, Bloomberg reports
Eli Lilly (LLY) increased its sale of Mounjaro, its weight-loss and diabetes drug, by 60% in India in May from April, Satviki Sanjay of Bloomberg reports. The company sold $1.5M worth of injections last month, Bloomberg said, citing market analysis firm Pharmarack Technologies. 'The patient number may have actually doubled' in May from April Pharmarack Vice President Sheetal Sapale told Bloomberg News. The demand is rising gradually and is expected to continue. Confident Investing Starts Here:
The Hill
15 hours ago
- The Hill
Beyond MAHA: Defeating obesity requires a new strategy
Obesity is a major health problem facing our country. According to the CDC, more than 40 percent of the U.S. population is obese, defined as having a body-mass index above 30. As astounding at that number is, it is perhaps even more surprising that nearly 20 percent of children in the U.S. are obese. Obesity leads to significant health challenges, including diabetes, stroke, cardiovascular disease and liver disease. It is clear that as a nation we must face this crisis on multiple fronts. Diet and exercise certainly help, and it's critical to ensure that people of all socioeconomic backgrounds have access to healthy foods (free of preservatives, unnecessary dyes, high fructose corn syrups etc.) and are educated in making healthy lifestyle choices. The MAHA or 'Make America Healthy Again' movement has highlighted this as one of its key objectives, and if it is successful, we should see an impact on obesity — especially in children, where diet and exercise have a huge impact on weight-related health outcomes. Obesity in adults, however, is often more challenging. Many adults with obesity struggle to lose weight, despite considerable efforts to modify their lifestyle through diet and exercise. This is because our metabolism changes as we age, and many adults who are overweight develop metabolic dysfunction or 'metabolic syndrome,' which then further perpetuates weight gain and exacerbates the situation. It has become clear in recent years that many people struggling with obesity require medical intervention – not just lifestyle intervention – and that prescriptions can substantially improve weight loss. The explosion in use of GLP-1 agonists, such as Wegovy and Zepbound, over the last two years has underscored the need for medical intervention in obese and overweight patients. Currently, about 6 percent of the U.S. population, or 15 million people, are on GLP-1 weight loss treatments, and the numbers are only expected to increase. However, while most patients lose 10 percent to 25 percent of their body weight while on a GLP-1, they do not maintain GLP-1 treatment in the long-term, with approximately 80 percent of patients discontinuing treatment within 1 year. Gastrointestinal side effects, injectable administration, and high cost have prevented long-term use of GLP-1's for weight maintenance. And unfortunately, most patients gain back all the weight after stopping the medication. Healthcare professionals and the pharmaceutical industry now recognize that obesity — like most other medical conditions — requires an 'arsenal' of treatments, rather than a one-size-fits-all approach. Post-GLP-1 weight maintenance is now widely recognized as an emerging unmet need. And patients who are not candidates for or cannot tolerate GLP-1s require alternatives. Diet and lifestyle modifications are important alongside prescription medications in fighting obesity. If we are going to be successful in overcoming this major health crisis, we need to ensure that both the pharmaceutical industry and groups like MAHA work hand in hand. Both treatment and prevention are critical in order to regain control of our nation's health. Dr. Shoshana Shendelman, Ph.D. is a scientist and entrepreneur who has founded numerous biotech companies. She is a pioneer in the development of drugs and therapeutics for rare and underserved diseases. Currently she is Vice Chair of the Advisory Board of Columbia University Medical Center and Columbia University Vagelos College of Physicians and Surgeons.
Yahoo
a day ago
- Yahoo
Why Recursion Pharmaceuticals (RXRX) Soared On Friday
We recently published a list of . In this article, we are going to take a look at where Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) stands against other Friday's best-performing stocks. Recursion Pharmaceuticals grew its share prices by 20.13 percent on Friday to close at $5.49 apiece following the unveiling of Boltz-2, touted as the next-generation AI model to predict binding affinity. According to Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX), the new model is powered by its NVIDIA supercomputer for its training and validation, and represents the next step beyond existing biomolecular structure prediction models like AlphaFold3 and its predecessor, Boltz-1. A pharmacist in a hospital pharmacy stands next to a row of various drug containers. 'Selecting the right molecules early is one of the most fundamental challenges in drug discovery, with implications for whether R&D programs succeed or fail,' said Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) Chief Commercial Officer Najat Khan. 'By predicting both molecular structure and binding affinity simultaneously with unprecedented speed and scale, Boltz-2 gives R&D teams a powerful tool to triage more effectively and focus resources on the most promising compounds. Collaborations like this, bridging academic innovation and industry application, play an important role in advancing the field and, ultimately, improving how we develop and deliver medicines for patients,' she added. Overall, RXRX ranks 2nd on our list of Friday's best-performing stocks. While we acknowledge the potential of RXRX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the best short-term AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
