Latest news with #ACHIEVE-1
Web Release
2 days ago
- Health
- Web Release
Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results
Eli Lilly and Company 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 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, and 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 Results Orforglipron 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 i Superiority test was adjusted for multiplicity. iiData from the full list of key secondary endpoints are available in the publication. iiiPercent 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, MD, 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.
Yahoo
24-06-2025
- Business
- Yahoo
Eli Lilly (LLY) Retains $1,100 Price Target at Bernstein Ahead of Diabetes Conference
Eli Lilly & Company (NYSE:LLY) is one of billionaire Stan Druckenmiller's top stock picks with huge upside potential. Bernstein SocGen Group reaffirmed its Outperform rating and $1,100 price target for Eli Lilly & Company (NYSE:LLY) on June 13 ahead of the 85th Annual Meeting of the American Diabetes Association. Pixabay/Public Domain The firm outlined a number of crucial data presentations that Eli Lilly & Company (NYSE:LLY) is expected to provide at the next meeting. One of these is the full description of the ACHIEVE-1 study, which is the first phase 3 trial from the late-stage clinical program of orforglipron. Bernstein is especially keen to acquire more information on the negative event profile and discontinuation rates, even if topline data is already available. Additionally, Eli Lilly & Company (NYSE:LLY) will provide information about its muscle-wasting medication, bimagrumab. When paired with tirzepatide, this will be the first clinical data reported for an anti-muscle wasting agent used in conjunction with a GLP-1 receptor agonist, possibly hinting at future use cases. Eli Lilly & Company (NYSE:LLY) is a major global pharmaceutical company that develops, manufactures, and distributes a wide range of drugs. Founded in 1876, it has grown to become one of the world's largest pharmaceutical companies. 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 More: and Disclosure: None. Connectez-vous pour accéder à votre portefeuille
Business Insider
24-06-2025
- Business
- Business Insider
Weight-Loss Drug Propels Eli Lilly Stock (LLY) Towards Record High
Eli Lilly and Company (LLY), the world's most valuable healthcare firm, is solidifying its leadership in the fast-growing obesity treatment market. Best known for its blockbuster drug Mounjaro/Zepbound, the company is advancing additional weight loss therapies through clinical trials and has recently unveiled promising data for two new treatments. Confident Investing Starts Here: While the stock has experienced some volatility over the past year, Eli Lilly's market leadership and continued innovation in obesity care support a bullish long-term outlook, given the substantial ~140% gain since 2022. In fact, after recovering from a slow start to 2025, LLY stock is within striking distance of its all-time high of $960 per share. According to Wall Street analysts, the stock is on track to set a new record high and potentially reach the psychologically significant milestone of $1,000 per share within 12 months. Zepbound's Blockbuster Growth Eli Lilly has seen significant growth in recent years, primarily driven by the success of its GLP-1/GIP obesity drug, Zepbound. Approved for obesity in November 2023, Zepbound still managed to generate nearly $5 billion in revenue in 2024, a remarkable performance given strong competition from Novo Nordisk's (NVO) Wegovy, which entered the market earlier. In fact, LLY registered 36% growth in its revenues last quarter while the sector average was just 6.7%. NVO posted revenue growth of 24.1%. LLY's revenue sources are pretty evenly split, as shown by TipRank's data. Eli Lilly has cited superior weight loss outcomes for Zepbound, likely due to its dual agonism, targeting two gut hormones that enhance weight loss efficacy. However, both Zepbound and Wegovy have challenges. They require weekly injections, which may deter some patients, and face supply chain constraints tied to complex manufacturing and cold storage. These limitations have increased interest in oral alternatives, which could broaden access and ease logistical hurdles, prompting multiple players, including Lilly, to invest in developing pill-based therapies. Oral Therapies Expand the Market Eli Lilly's most advanced oral obesity candidate, orforglipron, recently became the first small-molecule GLP-1 agonist to complete a Phase 3 trial. In April, results from the ACHIEVE-1 study showed that, among obese adults with diabetes, orforglipron lowered hemoglobin A1C by up to 1.6% and reduced body weight by 7.9% over 40 weeks. Importantly, the treatment's efficacy hadn't yet plateaued, suggesting further benefits with continued use. Its safety profile was consistent with other GLP-1 drugs, including common gastrointestinal side effects. Orforglipron could hit the market as soon as next year, with some analysts projecting peak annual sales of up to $8 billion. Meanwhile, Novo Nordisk is preparing to launch oral semaglutide, the pill form of the active ingredient in Wegovy. However, Lilly's orforglipron may hold a competitive edge—it's a small molecule, meaning it doesn't require food or water restrictions like semaglutide, potentially offering greater convenience and patient adherence. New Targets Emerge Beyond GLP-1/GIP Drug developers are increasingly exploring gut hormones beyond GLP-1 and GIP, with amylin receptor agonism emerging as a promising area. In June, Eli Lilly unveiled encouraging early data for its investigational amylin analogue, eloralintide, showing over 11% body weight loss in some patients within just three months, and notably, with minimal gastrointestinal side effects. Expanding into new hormonal pathways like amylin could help address the needs of patients who don't respond optimally to current GLP-1/GIP therapies, potentially broadening the reach of obesity treatment options. Is Eli Lilly a Good Stock to Buy? On Wall Street, LLY earns a Strong Buy consensus rating based on 16 Buy, two Hold, and one Sell ratings in the past three months. LLY's average price target of $999.57 implies a 31% upside potential over the next twelve months. Recently, Leerink Partners analyst David Risinge r issued a Buy rating on LLY. He pointed to the company's recent acquisition of Verve Therapeutics, a biotechnology company developing gene therapies for the prevention of cardiovascular disease, as an expansion of Eli Lilly's focus on its cardiometabolic research and development efforts. So, it's not just obesity Eli Lilly is targeting. Elsewhere, Morgan Stanley analyst Terence Flynn reiterated a Buy rating on LLY with a hefty price target of $1,133. Flynn was encouraged by Eli Lilly's progress in expanding market access for Zepbound, which is often uncovered by insurance and results in large out-of-pocket expenses for patients. Notably, Cigna, a large healthcare insurer, announced a 'new benefit option capping patient copays at $200 per month on both Lilly's Zepbound and Novo's Wegovy and maintaining its less exclusionary approach.' Zepbound Fuels LLY's Growth as Valuation Risks Linger Eli Lilly's Zepbound is doing more than generating blockbuster revenue—it's also fueling the company's long-term growth strategy. The cash flow from Zepbound is being reinvested into promising areas like oral obesity therapy orforglipron and strategic moves such as the acquisition of Verve. Since no single drug can drive growth indefinitely, Zepbound is playing a pivotal role in both sustaining current performance and funding the next wave of innovation. Going forward, a key focus will be on expanding access to Zepbound and advancing oral therapies to broaden the addressable market for obesity. Encouragingly, Lilly appears to be making steady progress, even amid recent stock volatility. That said, there are notable risks. Zepbound accounts for roughly 18% of Eli Lilly's revenue, making the company vulnerable to safety concerns or increased competition. While orforglipron has a convenience advantage, it will face tough competition from oral semaglutide and a crowded pipeline of next-generation weight loss therapies. Additionally, LLY trades at a high P/E ratio of 65.5, indicating that much of its expected growth may already be factored into its stock price. All in all, Zepbound's impressive growth and Eli Lilly's weight loss pipeline are factors that investors can rely on, boding well for long-term growth and meriting a bullish outlook, despite some risks.
Indian Express
23-06-2025
- Health
- Indian Express
Eli Lilly's new oral weight loss pill works as well as injectables: Why this could be better than oral semaglutide?
The blockbuster weight loss drug, semaglutide, now has competition in orforglipron, which is just as safe as injectable alternatives and more effectively lowers HbA1c (average blood sugar count of three months) in patients with type 2 diabetes and obesity. The best part. No injections required — just a daily pill. The investigational once-daily pill by US manufacturer Eli Lilly lowered HbA1C 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, according to Phase 3 results of the ACHIEVE-1 trials, published in The New England Journal of Medicine. Orforglipron also led to an average weight loss of 16.0 lbs or 7.3 kg (7.9%) at the highest dose by week 40. 'The efficacy, safety, and tolerability are really consistent with the very best injectable GLP-1s,' Kenneth Custer, president of cardiometabolic health at Eli Lilly, was quoted as saying. Why is orforglipron effective? Orforglipron and semaglutide are both GLP-1 receptor agonists, which mimic the effects of the naturally occurring hormone GLP-1, which helps regulate blood sugar, reduce appetite and slow down gastric emptying. But while orforglipron is non-peptide, semaglutide is a peptide. Peptides are smaller than proteins, while non-peptides encompass a wider range of chemical compounds with diverse structures and functions. 'Orforglipron, being a non-peptide, is a smaller molecule. This allows better absorption of the drug through the gut. They don't get broken down as easily by digestive enzymes. Hence the efficacy,' says Dr Anoop Misra, chairman, diabetes and endocrinology, Fortis C-Doc. What are the advantages of orforglipron over semaglutide? Orforglipron is an oral pill taken once daily, while semaglutide is available as both an oral tablet (Rybelsus) and a subcutaneous injection (Ozempic, Wegovy). 'Previous oral GLP-1s like semaglutide (Rybelsus) are peptide-based and have significant limitations — they must be taken on an empty stomach with minimal water and have much lower bioavailability than injectable form. Orforglipron is a small molecule that doesn't require food or water restrictions, so it is very convenient and is absorbed easily,' says Dr Misra. What about the trial results? At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary goal of superior HbA1C reduction. Improvements in HbA1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose. '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,' 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. What about side effects? In the study, orforglipron had a safety profile similar to the established GLP-1 class of medication. The most frequently reported adverse events were gastrointestinal-related.
India Today
23-06-2025
- Health
- India Today
Eli Lilly's new pill shows similar results to popular weight-loss drugs
A new experimental anti-diabetes pill, orforglipron, appears to be just as good as popular injectable GLP-1 drugs like Ozempic, according to new data from a Phase 3 study, part of a large clinical trial called ACHIEVE-1, looked at how well this once-daily pill worked in people with type 2 diabetes who were not able to control their blood sugar with diet and exercise most diabetes medications in the GLP-1 class, which are usually given as injections, orforglipron is an oral pill that can be taken without any food or water restrictions. It belongs to a group of medicines known as GLP-1 receptor agonists, which help control blood sugar levels and may also help with weight 40 weeks, people who took orforglipron saw a significant drop in their HbA1c levels. HbA1c is a blood test that shows the average blood sugar level over the past 2–3 most patients, their HbA1c dropped by 1.3% to 1.6%, which is a meaningful improvement. Many participants also achieved target blood sugar levels recommended by of the additional benefits of orforglipron was weight loss. People on higher doses lost around 7.3 kg on average, a bonus for many with type 2 diabetes who struggle with weight most common side effects were related to the stomach, such as nausea, diarrhea, and constipation, but these were mostly mild and occurred early in pill had a safety profile similar to existing GLP-1 injectable medicine company Eli Lilly, who has developed the drug, says it will continue testing orforglipron in more people and hopes to submit it for approval as a treatment for diabetes and weight management in the coming approved, it could offer a convenient and effective option for people who prefer pills over injections in managing type 2 diabetes.
