Latest news with #orforglipron
Yahoo
2 days ago
- Business
- Yahoo
Truist Reiterates Eli Lilly (LLY) Buy Rating on Orforglipron Diabetes Drug Data
Eli Lilly and Company (NYSE:LLY) is one of the 12 stocks that will make you rich in 10 years. On June 23, Truist Securities reiterated its 'Buy' rating on Eli Lilly stock. The firm also maintained the price target of $1,038.00. Truist's move followed Eli Lilly's presentation at the American Diabetes Association (ADA) 85th Annual Meeting. Pixabay/Public Domain The rating pertains to Eli Lilly's oral diabetes drug, orforglipron (OFG), evaluated in the Phase 3 ACHIEVE-1 study for Type 2 diabetes treatment. The ACHIEVE-1 study results were presented at the ADA conference, showcasing orforglipron's efficacy and safety profile. The trial demonstrated statistically significant reductions in A1C (a long-term blood sugar metric) and body weight compared to placebo, with efficacy increasing at higher doses. Truist's analysis was informed by attending the orforglipron presentation, gathering feedback from KOLs at the ADA conference, and participating in Eli Lilly's investor event, where management provided clarity to alleviate safety concerns. The firm noted that longer-term data are required to further strengthen orforglipron's safety profile, particularly for chronic use in diabetes and potential obesity indications. Eli Lilly and Company (NYSE:LLY) is an American global biopharmaceutical company. The company discovers, develops, and markets prescription medicines for diabetes, obesity, cancer, immunological disorders, and neurological diseases. Its key products include Mounjaro, Zepbound, Trulicity, Verzenio, Taltz, and Jardiance. While we acknowledge the potential of LLY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None.
Yahoo
22-06-2025
- Business
- Yahoo
Eli Lilly (NYSE:LLY) Advances Orforglipron GLP-1 Therapy To Phase 3 With Positive Results
Eli Lilly recently announced positive Phase 3 trial results for orforglipron, the first oral small molecule GLP-1 receptor agonist showing superior A1C reduction in type 2 diabetes patients, which aligns with a 7% share price increase over the last month. This, along with new offerings for Zepbound and strategic collaborations, potentially supported the company's stock performance. While the broader market showed a flat trajectory, the company's developments likely added weight to its upward trend. The ongoing lawsuit and acquisition rumors were less likely to significantly influence its share performance this month. We've identified 2 warning signs with Eli Lilly (at least 1 which is significant) and understanding the impact should be part of your investment process. The latest GPUs need a type of rare earth metal called Terbium and there are only 24 companies in the world exploring or producing it. Find the list for free. The recent advancements announced by Eli Lilly, particularly the positive Phase 3 trial results for orforglipron, could have significant implications for the company's growth narrative. These developments, alongside the expansion of its product offerings in oncology and immunology, bolster the potential for revenue acceleration. As the company progresses with new drug approvals and scales manufacturing capabilities, it strengthens its stance in crucial therapeutic areas. The strategic expansion is tied to analyst forecasts that anticipate higher revenue and profit margins, reinforcing Lilly's commitment to capturing larger market share and enhancing future earnings potential. Over the past five years, Eli Lilly's total shareholder return, including share price and dividends, skyrocketed by nearly 396.74%. This considerable increase underscores the company's capacity for growth, contrasting with its underperformance compared to the US Pharmaceuticals industry over the last year, where the industry saw an 11.2% decline. Analysts expect Eli Lilly's annual earnings growth to significantly outpace the broader market, aligning with the company's ongoing investments and strategic initiatives. These promising developments are expected to impact revenue and earnings forecasts positively. Anticipated growth in revenue by 20.2% annually over the next three years could support the company's trajectory toward higher earnings, which analysts project to reach US$31.7 billion by 2028. The current share price, US$775.12, shows a discount to the consensus analyst price target of US$981.63, indicating potential room for appreciation if the company meets expectations. However, investors should perform their own assessments to ensure alignment with these forecasts. Click here to discover the nuances of Eli Lilly with our detailed analytical financial health report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:LLY. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ 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
Yahoo
22-06-2025
- Health
- Yahoo
Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine
The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from ACHIEVE-1, a Phase 3 trial evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related. The results were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025 and simultaneously published in The New England Journal of Medicine. In the study, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by 1.3% to 1.6% from a baseline of 8.0%, for the efficacy estimand.1 In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the ADA treatment target A1C of <7%, 66.0% achieved an A1C of ≤6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value.2,3 Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. In another key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 16.0 lbs (7.9%). While participants in ACHIEVE-1 did not appear to reach a weight plateau, longer-duration trials, such as the ATTAIN trials, will provide a comprehensive evaluation of the safety and efficacy of orforglipron for the treatment of obesity. "The ACHIEVE-1 trial demonstrated that orforglipron, a novel oral small-molecule GLP-1, achieved clinically meaningful reductions in A1C and body weight over 40 weeks in adults with type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator. "The early onset of glycemic improvement, observed as soon as four weeks, reinforces the therapeutic potential of orforglipron as an effective, oral GLP-1 therapy for early type 2 diabetes treatment. These findings support further investigation in broader populations and longer-duration studies." Full ResultsOrforglipron 3 mg Orforglipron 12 mg Orforglipron 36 mg Placebo Primary Endpoint A1C reduction from baseline of 8.0 %i Efficacy estimand 1.3 % 1.6 % 1.5 % 0.1 % Treatment-regimen estimand4 1.2 % 1.5 % 1.5 % 0.4 % Key Secondary Endpointsii Percent weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.7 % 6.1 % 7.9 % 1.6 % Treatment-regimen estimand 4.5 % 5.8 % 7.6 % 1.7 % Weight reduction from baseline of 90.2 kg (198.9 lbs)i,iii Efficacy estimand 4.4 kg (9.7 lbs) 5.5 kg (12.2 lbs) 7.3 kg (16.0 lbs) 1.3 kg (2.9 lbs) Treatment-regimen estimand 4.2 kg (9.3 lbs) 5.2 kg (11.5 lbs) 7.2 kg (15.8 lbs) 1.5 kg (3.4 lbs) Percent of participants achieving A1C <7 %i Efficacy estimand 72.9 % 76.2 % 74.9 % 28.0 % Treatment-regimen estimand 68.1 % 72.9 % 72.7 % 33.0 % Percent of participants achieving A1C ≤6.5 %i,ii Efficacy estimand 61.5 % 62.3 % 66.0 % 13.5 % Treatment-regimen estimand 56.9 % 58.1 % 61.9 % 14.9 % Percent of participants achieving A1C <5.7 %iii Efficacy estimand 17.7 % 25.8 % 23.9 % 3.8 % Treatment-regimen estimand 16.8 % 23.9 % 21.5 % 3.8 % Fasting serum glucose reduction from baseline of 147.5 mg/dLi Efficacy estimand 30.6 mg/dL 37.4 mg/dL 37.8 mg/dL 1.1 mg/dL Treatment-regimen estimand 30.7 mg/dL 36.5 mg/dL 34.7 mg/dL 10.8 mg/dL iSuperiority test was adjusted for from the full list of key secondary endpoints are available in the of participants achieving A1C <5.7% across all orforglipron doses and body weight for orforglipron 3 mg were not controlled for Type 1 error. "This convenient once-daily pill with no restrictions on food and water intake could be an option for millions of people with type 2 diabetes who prefer oral medications over injectables," said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. "The positive ACHIEVE-1 results position orforglipron as a potential treatment option with meaningful A1C and weight reduction, and a safety profile similar to injectable GLP-1 therapies. We look forward to the four remaining global readouts from the ACHIEVE program, as well as results of the ATTAIN program in obesity, and working with regulators to bring this once-daily oral GLP-1 to people around the world." The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. The most common adverse events for participants treated with orforglipron (3 mg, 12 mg and 36 mg, respectively) were diarrhea (19%, 21% and 26%) vs. 9% with placebo, nausea (13%, 18% and 16%) vs. 2% with placebo, dyspepsia (11%, 20% and 15%) vs. 7% with placebo, constipation (8%, 17% and 14%) vs. 4% with placebo, and vomiting (5%, 7% and 14%) vs. 1% with placebo. These gastrointestinal-related adverse events were generally mild-to-moderate in severity and occurred primarily during dose escalation. Overall treatment discontinuation rates due to adverse events were 6% (3 mg), 4% (12 mg) and 8% (36 mg) for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Later this year, Lilly expects to share topline results from ACHIEVE-2, evaluating orforglipron compared with dapagliflozin, and ACHIEVE-3, evaluating orforglipron compared to oral semaglutide, both in adults with type 2 diabetes inadequately controlled with metformin. ATTAIN-1 and ATTAIN-2, evaluating orforglipron for weight management, will also be shared in the third quarter of this year. Lilly remains on track to submit orforglipron for weight management to global regulatory agencies by the end of this year and for the treatment of type 2 diabetes in 2026. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.6 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity. About ACHIEVE-1 and the ACHIEVE clinical trial program ACHIEVE-1 (NCT05971940) is a Phase 3, 40-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 3 mg, 12 mg and 36 mg as monotherapy to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The trial randomized 559 participants across the U.S., China, India, Japan and Mexico in 1:1:1:1 ratio to receive either 3 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (3 mg, 12 mg, 36 mg) is superior in A1C reduction from baseline after 40 weeks, compared to placebo, in people with type 2 diabetes who have not taken any anti-diabetic medications for at least 90 days prior to visit 1, and are naïve to insulin therapy. Study participants had a HbA1c between ≥7.0% and ≤9.5% and a BMI of ≥23 kg/m2. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 3 mg (via a 1 mg step), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Flexible dosing was not permitted. The ACHIEVE Phase 3 global clinical development program for orforglipron has enrolled more than 6,000 people with type 2 diabetes across five global registration trials. The program began in 2023 with results anticipated later this year and into 2026. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY The efficacy estimand represents the treatment effect had on all participants who adhered to the study drug (with possible dose interruptions) for 40 weeks without initiating additional antihyperglycemic medications (>14 days of use). American Diabetes Association. Standards of Care in Diabetes—2020 Abridged for Primary Care Providers. Clinical Diabetes 2020; 38(1):10–38. Percent of participants achieving A1C <5.7% across all doses was not controlled for Type 1 error. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or initiation of additional antihyperglycemic medications. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with type 2 diabetes, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for type 2 diabetes, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Brooke Frost; 317-432-9145 (Media)Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company
Yahoo
21-06-2025
- Health
- Yahoo
Lilly expects orforglipron obesity results in third quarter
By Deena Beasley (Reuters) -Eli Lilly said on Saturday its experimental pill orforglipron helped diabetics lose weight and lower their blood sugar, and the company aims to announce in the third quarter trial results for the drug in overweight and obese people without diabetes. Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission. Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026. Full results of the diabetes trial were presented at the annual meeting of the American Diabetes Association in Chicago. The Phase 3 study showed that type 2 diabetes patients taking the highest dose of daily orforglipron lost nearly 8% of their body weight over 40 weeks. That compares favorably with Novo Nordisk's injected drug Ozempic, for which trials showed that diabetic patients on the highest dose lost roughly 6% of their body weight. Lilly's pill, which can be taken without food or water, lowered blood sugar levels by an average of 1.3% to 1.6% across doses. The company said the most frequently reported side effects were gastrointestinal and similar to other GLP-1 drugs, including diarrhea and vomiting. Custer said Lilly's goal in its non-diabetes trials is to achieve weight loss consistent with GLP-1 drugs that are currently available. Ozempic was shown in trials to lead to weight loss of 15% for people without diabetes over 68 weeks. He said orforglipron, which has a simpler production process than injected GLP-1 drugs such as Ozempic or Lilly's Zepbound and does not require cold storage, could mean wider global access to weight-loss drugs. "This is the type of molecule that is going to allow us to reach the broader globe," Custer said. The executive declined to comment on pricing plans for orforglipron. (Reporting By Deena BeasleyEditing by Rod Nickel)
Reuters
21-06-2025
- Health
- Reuters
Lilly expects orforglipron obesity results in third quarter
June 21 (Reuters) - Eli Lilly (LLY.N), opens new tab said on Saturday its experimental pill orforglipron helped diabetics lose weight and lower their blood sugar, and the company aims to announce in the third quarter trial results for the drug in overweight and obese people without diabetes. Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission. Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026. Full results of the diabetes trial were presented at the annual meeting of the American Diabetes Association in Chicago. The Phase 3 study showed that type 2 diabetes patients taking the highest dose of daily orforglipron lost nearly 8% of their body weight over 40 weeks. That compares favorably with Novo Nordisk's ( opens new tab injected drug Ozempic, for which trials showed that diabetic patients on the highest dose lost roughly 6% of their body weight. Lilly's pill, which can be taken without food or water, lowered blood sugar levels by an average of 1.3% to 1.6% across doses. The company said the most frequently reported side effects were gastrointestinal and similar to other GLP-1 drugs, including diarrhea and vomiting. Custer said Lilly's goal in its non-diabetes trials is to achieve weight loss consistent with GLP-1 drugs that are currently available. Ozempic was shown in trials to lead to weight loss of 15% for people without diabetes over 68 weeks. He said orforglipron, which has a simpler production process than injected GLP-1 drugs such as Ozempic or Lilly's Zepbound and does not require cold storage, could mean wider global access to weight-loss drugs. "This is the type of molecule that is going to allow us to reach the broader globe," Custer said. The executive declined to comment on pricing plans for orforglipron.
