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.
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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.
Impact of LLY’s Latest Phase III Success on NVO
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 and Consensus
Eli Lilly and Company Price and Consensus
Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote
Other GLP-1 Obesity Pill Makers Benefit From LLY News
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.
LLY’s Zacks Rank
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.
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