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Tests Show Eli Lilly's (LLY) Weight-Loss Pill Works as Well as Injection
Tests Show Eli Lilly's (LLY) Weight-Loss Pill Works as Well as Injection

Business Insider

time21 hours ago

  • Health
  • Business Insider

Tests Show Eli Lilly's (LLY) Weight-Loss Pill Works as Well as Injection

Preliminary test results show that Eli Lilly's (LLY) daily weight-loss pill, called Orforglipron, is as effective as the company's injectable GLP-1 drug Zepbound. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. The weight-loss pill from Eli Lilly is also equally good at lowering blood sugar levels in people with diabetes, according to new data from a Phase 3 clinical trial. The results were announced at the annual meeting of the American Diabetes Association and the findings published in the prestigious New England Journal of Medicine. Pharmaceutical giant Eli Lilly currently makes the blockbuster drug Mounjaro for Type 2 diabetes and Zepbound for weight management. Like rival Novo Nordisk's (NVO) Ozempic and Wegovy, both of Eli Lilly's drugs are injected by people on a weekly basis. However, a weight-loss pill is widely viewed as a potential gamechanger given many people's fear of needles and difficulty injecting themselves. Race for the Pill Eli Lilly, Novo Nordisk, and other pharmaceutical companies are racing to bring a weight-loss pill to market. Eli Lilly's Orforglipron pill is currently in late stage clinical trials and could be approved by the U.S. Food and Drug Administration (FDA) in 2026, though an exact date is not yet known. So far, preliminary data on Eli Lilly's pill to help manage obesity is showing promising results. 'What we see is that the efficacy, safety, and tolerability are really consistent with the very best injectable (medications),' said Kenneth Custer, President of Cariometabolic Health at Eli Lilly, in a news release concerning the company's experimental pill. 'We think this is a big deal.' Is LLY Stock a Buy? The stock of Eli Lilly has a consensus Strong Buy recommendation among 19 Wall Street analysts. That rating is based on 16 Buy, two Hold, and one Sell recommendations issued in the last 12 months. The average LLY price target of $999.57 implies 28.83% upside from current levels.

Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results
Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results

Web Release

timea day 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.

Eli Lilly's new oral weight loss pill works as well as injectables: Why this could be better than oral semaglutide?
Eli Lilly's new oral weight loss pill works as well as injectables: Why this could be better than oral semaglutide?

Indian Express

time23-06-2025

  • 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.

'Game changer' diabetes pill a step closer after trials
'Game changer' diabetes pill a step closer after trials

The Advertiser

time22-06-2025

  • Health
  • The Advertiser

'Game changer' diabetes pill a step closer after trials

Game-changing diabetes pills could hit Australian shelves within years, offering an alternative to popular injectable treatments like Ozempic that have been plagued with supply issues. That's the prediction from Australian diabetes experts, as the first phase three clinical trial data was released for a new type of medicine that lowers blood sugar. Once-a-day pill Orforglipron was shown to imitate a naturally occurring hormone that helps regulate blood sugar and appetite, according to the study published in the prestigious New England Journal of Medicine. "It's really, really exciting," Australian Diabetes Society chief executive Associate Professor Sof Andrikopoulos told AAP. "The reduction in blood glucose and weight with Orforglipron is similar, if not a little bit better, than the similar clinical trials that were done for Ozempic and Mounjaro." The results of the trials, involving 500 adults with type 2 diabetes, were unveiled at the American Diabetes Association annual meeting in Chicago over the weekend. Reported side effects were similar to existing medications like gastrointestinal issues, while the drug company did not flag any unexpected safety concerns. The trial focused on diabetes treatment and not specifically weight loss. Other oral diabetes medications already exist but this medication is significant as it's the first synthetic treatment to reach phase three trials, Prof Andrikopoulos said. He expected approval from the Therapeutic Goods Administration would be "reasonable straightforward" once it receives an application by drug developer Eli Lilly, which also makes Mounjaro. The synthetic chemical is easier to make than other drugs involving modified peptides and doesn't need to be refrigerated, hoping it would be cheaper and easier to transport to remote areas than injectable treatments. "These are potentially disease modifying therapies, and in that respect it's a game-changer," Prof Andrikopoulos said. "In terms of managing types of diabetes and obesity, I think we are at the cusp of being able to make a significant impact on reducing obesity in Australia and around the world." Sydney-based Endocrinologist Associate Professor Ted Wu treats many patients with diabetes and said physicians had been "crying out" for oral alternatives to incretin injections. While optimistic about the findings, he cautioned it was not a "head to head" trial measuring the effectiveness of Orforglipron against injections but said it appears the results were very similar. "As it stands, this looks like it offers all the advantages of the current incretin injections, but with all the advantages of an oral once-a-day medication and hopefully with far fewer supply issues," he said. Prof Wu said looking at past performance, the TGA would probably take between 12 and 24 months to approve the new drug. Game-changing diabetes pills could hit Australian shelves within years, offering an alternative to popular injectable treatments like Ozempic that have been plagued with supply issues. That's the prediction from Australian diabetes experts, as the first phase three clinical trial data was released for a new type of medicine that lowers blood sugar. Once-a-day pill Orforglipron was shown to imitate a naturally occurring hormone that helps regulate blood sugar and appetite, according to the study published in the prestigious New England Journal of Medicine. "It's really, really exciting," Australian Diabetes Society chief executive Associate Professor Sof Andrikopoulos told AAP. "The reduction in blood glucose and weight with Orforglipron is similar, if not a little bit better, than the similar clinical trials that were done for Ozempic and Mounjaro." The results of the trials, involving 500 adults with type 2 diabetes, were unveiled at the American Diabetes Association annual meeting in Chicago over the weekend. Reported side effects were similar to existing medications like gastrointestinal issues, while the drug company did not flag any unexpected safety concerns. The trial focused on diabetes treatment and not specifically weight loss. Other oral diabetes medications already exist but this medication is significant as it's the first synthetic treatment to reach phase three trials, Prof Andrikopoulos said. He expected approval from the Therapeutic Goods Administration would be "reasonable straightforward" once it receives an application by drug developer Eli Lilly, which also makes Mounjaro. The synthetic chemical is easier to make than other drugs involving modified peptides and doesn't need to be refrigerated, hoping it would be cheaper and easier to transport to remote areas than injectable treatments. "These are potentially disease modifying therapies, and in that respect it's a game-changer," Prof Andrikopoulos said. "In terms of managing types of diabetes and obesity, I think we are at the cusp of being able to make a significant impact on reducing obesity in Australia and around the world." Sydney-based Endocrinologist Associate Professor Ted Wu treats many patients with diabetes and said physicians had been "crying out" for oral alternatives to incretin injections. While optimistic about the findings, he cautioned it was not a "head to head" trial measuring the effectiveness of Orforglipron against injections but said it appears the results were very similar. "As it stands, this looks like it offers all the advantages of the current incretin injections, but with all the advantages of an oral once-a-day medication and hopefully with far fewer supply issues," he said. Prof Wu said looking at past performance, the TGA would probably take between 12 and 24 months to approve the new drug. Game-changing diabetes pills could hit Australian shelves within years, offering an alternative to popular injectable treatments like Ozempic that have been plagued with supply issues. That's the prediction from Australian diabetes experts, as the first phase three clinical trial data was released for a new type of medicine that lowers blood sugar. Once-a-day pill Orforglipron was shown to imitate a naturally occurring hormone that helps regulate blood sugar and appetite, according to the study published in the prestigious New England Journal of Medicine. "It's really, really exciting," Australian Diabetes Society chief executive Associate Professor Sof Andrikopoulos told AAP. "The reduction in blood glucose and weight with Orforglipron is similar, if not a little bit better, than the similar clinical trials that were done for Ozempic and Mounjaro." The results of the trials, involving 500 adults with type 2 diabetes, were unveiled at the American Diabetes Association annual meeting in Chicago over the weekend. Reported side effects were similar to existing medications like gastrointestinal issues, while the drug company did not flag any unexpected safety concerns. The trial focused on diabetes treatment and not specifically weight loss. Other oral diabetes medications already exist but this medication is significant as it's the first synthetic treatment to reach phase three trials, Prof Andrikopoulos said. He expected approval from the Therapeutic Goods Administration would be "reasonable straightforward" once it receives an application by drug developer Eli Lilly, which also makes Mounjaro. The synthetic chemical is easier to make than other drugs involving modified peptides and doesn't need to be refrigerated, hoping it would be cheaper and easier to transport to remote areas than injectable treatments. "These are potentially disease modifying therapies, and in that respect it's a game-changer," Prof Andrikopoulos said. "In terms of managing types of diabetes and obesity, I think we are at the cusp of being able to make a significant impact on reducing obesity in Australia and around the world." Sydney-based Endocrinologist Associate Professor Ted Wu treats many patients with diabetes and said physicians had been "crying out" for oral alternatives to incretin injections. While optimistic about the findings, he cautioned it was not a "head to head" trial measuring the effectiveness of Orforglipron against injections but said it appears the results were very similar. "As it stands, this looks like it offers all the advantages of the current incretin injections, but with all the advantages of an oral once-a-day medication and hopefully with far fewer supply issues," he said. Prof Wu said looking at past performance, the TGA would probably take between 12 and 24 months to approve the new drug. Game-changing diabetes pills could hit Australian shelves within years, offering an alternative to popular injectable treatments like Ozempic that have been plagued with supply issues. That's the prediction from Australian diabetes experts, as the first phase three clinical trial data was released for a new type of medicine that lowers blood sugar. Once-a-day pill Orforglipron was shown to imitate a naturally occurring hormone that helps regulate blood sugar and appetite, according to the study published in the prestigious New England Journal of Medicine. "It's really, really exciting," Australian Diabetes Society chief executive Associate Professor Sof Andrikopoulos told AAP. "The reduction in blood glucose and weight with Orforglipron is similar, if not a little bit better, than the similar clinical trials that were done for Ozempic and Mounjaro." The results of the trials, involving 500 adults with type 2 diabetes, were unveiled at the American Diabetes Association annual meeting in Chicago over the weekend. Reported side effects were similar to existing medications like gastrointestinal issues, while the drug company did not flag any unexpected safety concerns. The trial focused on diabetes treatment and not specifically weight loss. Other oral diabetes medications already exist but this medication is significant as it's the first synthetic treatment to reach phase three trials, Prof Andrikopoulos said. He expected approval from the Therapeutic Goods Administration would be "reasonable straightforward" once it receives an application by drug developer Eli Lilly, which also makes Mounjaro. The synthetic chemical is easier to make than other drugs involving modified peptides and doesn't need to be refrigerated, hoping it would be cheaper and easier to transport to remote areas than injectable treatments. "These are potentially disease modifying therapies, and in that respect it's a game-changer," Prof Andrikopoulos said. "In terms of managing types of diabetes and obesity, I think we are at the cusp of being able to make a significant impact on reducing obesity in Australia and around the world." Sydney-based Endocrinologist Associate Professor Ted Wu treats many patients with diabetes and said physicians had been "crying out" for oral alternatives to incretin injections. While optimistic about the findings, he cautioned it was not a "head to head" trial measuring the effectiveness of Orforglipron against injections but said it appears the results were very similar. "As it stands, this looks like it offers all the advantages of the current incretin injections, but with all the advantages of an oral once-a-day medication and hopefully with far fewer supply issues," he said. Prof Wu said looking at past performance, the TGA would probably take between 12 and 24 months to approve the new drug.

'Game changer' diabetes pill a step closer after trials
'Game changer' diabetes pill a step closer after trials

West Australian

time22-06-2025

  • Health
  • West Australian

'Game changer' diabetes pill a step closer after trials

Game-changing diabetes pills could hit Australian shelves within years, offering an alternative to popular injectable treatments like Ozempic that have been plagued with supply issues. That's the prediction from Australian diabetes experts, as the first phase three clinical trial data was released for a new type of medicine that lowers blood sugar. Once-a-day pill Orforglipron was shown to imitate a naturally occurring hormone that helps regulate blood sugar and appetite, according to the study published in the prestigious New England Journal of Medicine. "It's really, really exciting," Australian Diabetes Society chief executive Associate Professor Sof Andrikopoulos told AAP. "The reduction in blood glucose and weight with Orforglipron is similar, if not a little bit better, than the similar clinical trials that were done for Ozempic and Mounjaro." The results of the trials, involving 500 adults with type 2 diabetes, were unveiled at the American Diabetes Association annual meeting in Chicago over the weekend. Reported side effects were similar to existing medications like gastrointestinal issues, while the drug company did not flag any unexpected safety concerns. The trial focused on diabetes treatment and not specifically weight loss. Other oral diabetes medications already exist but this medication is significant as it's the first synthetic treatment to reach phase three trials, Prof Andrikopoulos said. He expected approval from the Therapeutic Goods Administration would be "reasonable straightforward" once it receives an application by drug developer Eli Lilly, which also makes Mounjaro. The synthetic chemical is easier to make than other drugs involving modified peptides and doesn't need to be refrigerated, hoping it would be cheaper and easier to transport to remote areas than injectable treatments. "These are potentially disease modifying therapies, and in that respect it's a game-changer," Prof Andrikopoulos said. "In terms of managing types of diabetes and obesity, I think we are at the cusp of being able to make a significant impact on reducing obesity in Australia and around the world." Sydney-based Endocrinologist Associate Professor Ted Wu treats many patients with diabetes and said physicians had been "crying out" for oral alternatives to incretin injections. While optimistic about the findings, he cautioned it was not a "head to head" trial measuring the effectiveness of Orforglipron against injections but said it appears the results were very similar. "As it stands, this looks like it offers all the advantages of the current incretin injections, but with all the advantages of an oral once-a-day medication and hopefully with far fewer supply issues," he said. Prof Wu said looking at past performance, the TGA would probably take between 12 and 24 months to approve the new drug.

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