We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Does Lilly's New Obesity Pill Data Put It Back in the Weight Game?
Read MoreHide Full Article
Key Takeaways
LLY's ATTAIN-2 trial showed orforglipron cut weight by 22.9 lbs and lowered A1C up to 1.8%.
Results give Lilly the full dataset needed to begin global regulatory filings for orforglipron.
Despite mixed prior results, new data eased concerns and boosted LLY shares by nearly 6% on Tuesday.
Eli Lilly and Company (LLY - Free Report) announced top-line data from the third of the seven phase III studies evaluating orforglipron, its GLP-1 once-daily oral pill, in patients with type II diabetes and obesity.
The ATTAIN-2 study, which was conducted in overweight and obese people with type II diabetes without food or water restrictions, met the primary and all key secondary endpoints for all three doses tested at 72 weeks.
The highest dose (36 mg) of orforglipron delivered a weight loss of up to an average of 22.9 lbs (10.5%) versus 5.1 lbs (2.2%) with placebo, thereby meeting the study’s primary endpoint of superior body weight reduction compared to placebo.
For the key secondary endpoints, orforglipron lowered A1C by an average of 1.3% to 1.8% across doses. In the study, 75% of patients given the highest dose of orforglipron achieved an A1C of ≤6.5%. According to the American Diabetes Association, if your A1C level is less than 6.5%, it means that your glucose levels have been in the prediabetes range.
In addition, orforglipron showed improvements in cardiometabolic risk factors including non-HDL cholesterol, systolic blood pressure and triglycerides.
The safety profile of orforglipron was consistent with injectable GLP-1 medicines. As regards patient discontinuation rates, 10.6% of patients in the 36 mg dose arm discontinued treatment due to adverse events versus 4.6% with placebo. Detailed data from the ATTAIN-2 study will be presented at a future medical meeting.
Completion of the ATTAIN-2 study provides Lilly with the full clinical dataset needed to begin global regulatory filings for orforglipron. The latest positive data on the oral obesity pill study lifted Lilly’s stock up by almost 6% on Tuesday.
LLY to Seek Approval for Orforglipron This Year
Earlier this month, Lilly had announced top-line data from the second study called ATTAIN-1 in people with obesity, but without type 2 diabetes. This study showed that patients taking the highest dose (36 mg) of orforglipron lost more than 27 pounds or 12.4% of their body weight.
However, the 12.4% weight loss achieved with the highest 36 mg dose of orforglipron in the ATTAIN-1 study fell short of investor expectations, and LLY’s shares crashed after the data was announced. Investors were probably expecting orforglipron to match rival Novo Nordisk’s (NVO - Free Report) Wegovy’s average weight loss in a range of 13-15% or even exceed that percentage. Patient discontinuation rates in the study were also considered high, with as high as 24.4% of the patients in the 36 mg dose arm discontinuing treatment.
Earlier this year, Lilly had announced positive data from another study called ACHIEVE-1 in type II diabetes patients. In the study, orforglipron lowered A1C by an average of 1.3%-1.6% across doses and also reduced weight by an average of 16lb (7.9%) at the highest dose.
Lilly plans to report data from three additional orforglipron phase III studies in diabetes and obesity over the next five months. Lilly plans to file regulatory applications for orforglipron in obesity later this year, setting up the timeline for a potential launch next year.
Lilly is also evaluating orforglipron in late-stage studies in other disease areas like obstructive sleep apnea and hypertension, and also plans to initiate a new phase III study in people with knee osteoarthritis pain in overweight or obesity later this year.
Orforglipron is a Key Candidate in LLY’s Obesity Pipeline
Orforglipron is being viewed as a key candidate in Lilly's obesity pipeline, which has the potential to transform the obesity treatment space as both Zepbound and NVO’s Wegovy are weekly injections. There is significant demand for convenient daily oral pills for weight loss that can be manufactured at scale to meet global demand. Lilly has scaled up its manufacturing capacity to meet potential demand for its novel drug/obesity medicines.
The obesity market is expected to expand to $100 billion by 2030, according to data from Goldman Sachs, which means fierce competition is inevitable. Though Lilly and Novo Nordisk presently dominate the market, they are making rapid progress in the development of more potent and convenient GLP-1-based candidates in their clinical pipeline to beat future competition.
Lilly has several new molecules currently in clinical development. Other than orforglipron, Lilly has another late-stage candidate in its obesity pipeline called retatrutide, a GGG tri-agonist. Lilly is conducting late-stage studies on retatrutide in obesity, obstructive sleep apnea, knee osteoarthritis, chronic low back pain and type II diabetes. It expects the first data readout from a phase III study on retatrutide in osteoarthritis of the knees later in 2025. It also has some mid-stage candidates, bimagrumab, eloralintide and mazdutide.
The ATTAIN-1 data led many investors to feel that the potential market for orforglipron is now less than previously expected. However, the data from the ATTAIN-2 study seems to have eased some of these concerns and brought Lilly back on the obesity map. We believe that orforglipron has the potential to be approved as it has shown efficacy and safety consistent with injectable GLP-1 therapies while offering the convenience of a once-daily pill. Though the data from orforglipron studies has been mixed, some believe it may still be used for maintenance therapy after patients lose weight with injectable products like Zepbound or Wegovy, which is also a huge market.
Competition Heating Up in the Obesity Space
Several other companies, like Amgen (AMGN - Free Report) and Viking Therapeutics (VKTX - Free Report) , are also making rapid progress in the development of more potent and convenient GLP-1-based candidates in their clinical pipeline.
NVO, LLY and VKTX are racing to introduce oral weight-loss pills, as Wegovy and Zepbound are both injectable drugs. Novo Nordisk has already filed a new drug application (NDA) for an oral version of Wegovy and also has several next-generation candidates in its obesity pipeline, like CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist). The FDA is expected to decide on the Wegovy oral formulation NDA in the fourth quarter.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. The company recently announced mixed top-line results from a mid-stage study evaluating the safety and efficacy of the oral formulation of VK2735. Though patients on the highest drug dose lost up to 12.2% of their body weight after 13 weeks of daily dosing compared with 1.3% in the placebo group, a significant number of patients also dropped out of the study.
Phase III obesity studies with the subcutaneous formulation of VK2735 were recently initiated.
Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with a monthly and maybe less frequent dosing. In March, Amgen initiated two phase III studies on MariTide in obesity as part of its comprehensive MARITIME phase III program. Since June, Amgen has initiated two more phase III studies in other obesity related conditions.
LLY’s Stock Price, Valuation and Estimates
Lilly’s stock has declined 4.1% so far this year compared with the industry’s decrease of 0.2%.
Image Source: Zacks Investment Research
From a valuation standpoint, Lilly’s stock is expensive. Going by the price/earnings ratio, LLY’s shares currently trade at 26.12 forward earnings, much higher than 14.60 for the industry. However, LLY’s stock is trading below its 5-year mean of 34.54.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2025 has risen from $22.04 per share to $22.81 per share over the past 30 days, while that for 2026 has risen from $30.88 to $31.01 per share over the same timeframe.
Image: Bigstock
Does Lilly's New Obesity Pill Data Put It Back in the Weight Game?
Key Takeaways
Eli Lilly and Company (LLY - Free Report) announced top-line data from the third of the seven phase III studies evaluating orforglipron, its GLP-1 once-daily oral pill, in patients with type II diabetes and obesity.
The ATTAIN-2 study, which was conducted in overweight and obese people with type II diabetes without food or water restrictions, met the primary and all key secondary endpoints for all three doses tested at 72 weeks.
The highest dose (36 mg) of orforglipron delivered a weight loss of up to an average of 22.9 lbs (10.5%) versus 5.1 lbs (2.2%) with placebo, thereby meeting the study’s primary endpoint of superior body weight reduction compared to placebo.
For the key secondary endpoints, orforglipron lowered A1C by an average of 1.3% to 1.8% across doses. In the study, 75% of patients given the highest dose of orforglipron achieved an A1C of ≤6.5%. According to the American Diabetes Association, if your A1C level is less than 6.5%, it means that your glucose levels have been in the prediabetes range.
In addition, orforglipron showed improvements in cardiometabolic risk factors including non-HDL cholesterol, systolic blood pressure and triglycerides.
The safety profile of orforglipron was consistent with injectable GLP-1 medicines. As regards patient discontinuation rates, 10.6% of patients in the 36 mg dose arm discontinued treatment due to adverse events versus 4.6% with placebo. Detailed data from the ATTAIN-2 study will be presented at a future medical meeting.
Completion of the ATTAIN-2 study provides Lilly with the full clinical dataset needed to begin global regulatory filings for orforglipron. The latest positive data on the oral obesity pill study lifted Lilly’s stock up by almost 6% on Tuesday.
LLY to Seek Approval for Orforglipron This Year
Earlier this month, Lilly had announced top-line data from the second study called ATTAIN-1 in people with obesity, but without type 2 diabetes. This study showed that patients taking the highest dose (36 mg) of orforglipron lost more than 27 pounds or 12.4% of their body weight.
However, the 12.4% weight loss achieved with the highest 36 mg dose of orforglipron in the ATTAIN-1 study fell short of investor expectations, and LLY’s shares crashed after the data was announced. Investors were probably expecting orforglipron to match rival Novo Nordisk’s (NVO - Free Report) Wegovy’s average weight loss in a range of 13-15% or even exceed that percentage. Patient discontinuation rates in the study were also considered high, with as high as 24.4% of the patients in the 36 mg dose arm discontinuing treatment.
Earlier this year, Lilly had announced positive data from another study called ACHIEVE-1 in type II diabetes patients. In the study, orforglipron lowered A1C by an average of 1.3%-1.6% across doses and also reduced weight by an average of 16lb (7.9%) at the highest dose.
Lilly plans to report data from three additional orforglipron phase III studies in diabetes and obesity over the next five months. Lilly plans to file regulatory applications for orforglipron in obesity later this year, setting up the timeline for a potential launch next year.
Lilly is also evaluating orforglipron in late-stage studies in other disease areas like obstructive sleep apnea and hypertension, and also plans to initiate a new phase III study in people with knee osteoarthritis pain in overweight or obesity later this year.
Orforglipron is a Key Candidate in LLY’s Obesity Pipeline
Orforglipron is being viewed as a key candidate in Lilly's obesity pipeline, which has the potential to transform the obesity treatment space as both Zepbound and NVO’s Wegovy are weekly injections. There is significant demand for convenient daily oral pills for weight loss that can be manufactured at scale to meet global demand. Lilly has scaled up its manufacturing capacity to meet potential demand for its novel drug/obesity medicines.
The obesity market is expected to expand to $100 billion by 2030, according to data from Goldman Sachs, which means fierce competition is inevitable. Though Lilly and Novo Nordisk presently dominate the market, they are making rapid progress in the development of more potent and convenient GLP-1-based candidates in their clinical pipeline to beat future competition.
Lilly has several new molecules currently in clinical development. Other than orforglipron, Lilly has another late-stage candidate in its obesity pipeline called retatrutide, a GGG tri-agonist. Lilly is conducting late-stage studies on retatrutide in obesity, obstructive sleep apnea, knee osteoarthritis, chronic low back pain and type II diabetes. It expects the first data readout from a phase III study on retatrutide in osteoarthritis of the knees later in 2025. It also has some mid-stage candidates, bimagrumab, eloralintide and mazdutide.
The ATTAIN-1 data led many investors to feel that the potential market for orforglipron is now less than previously expected. However, the data from the ATTAIN-2 study seems to have eased some of these concerns and brought Lilly back on the obesity map. We believe that orforglipron has the potential to be approved as it has shown efficacy and safety consistent with injectable GLP-1 therapies while offering the convenience of a once-daily pill. Though the data from orforglipron studies has been mixed, some believe it may still be used for maintenance therapy after patients lose weight with injectable products like Zepbound or Wegovy, which is also a huge market.
Competition Heating Up in the Obesity Space
Several other companies, like Amgen (AMGN - Free Report) and Viking Therapeutics (VKTX - Free Report) , are also making rapid progress in the development of more potent and convenient GLP-1-based candidates in their clinical pipeline.
NVO, LLY and VKTX are racing to introduce oral weight-loss pills, as Wegovy and Zepbound are both injectable drugs. Novo Nordisk has already filed a new drug application (NDA) for an oral version of Wegovy and also has several next-generation candidates in its obesity pipeline, like CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist). The FDA is expected to decide on the Wegovy oral formulation NDA in the fourth quarter.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. The company recently announced mixed top-line results from a mid-stage study evaluating the safety and efficacy of the oral formulation of VK2735. Though patients on the highest drug dose lost up to 12.2% of their body weight after 13 weeks of daily dosing compared with 1.3% in the placebo group, a significant number of patients also dropped out of the study.
Phase III obesity studies with the subcutaneous formulation of VK2735 were recently initiated.
Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with a monthly and maybe less frequent dosing. In March, Amgen initiated two phase III studies on MariTide in obesity as part of its comprehensive MARITIME phase III program. Since June, Amgen has initiated two more phase III studies in other obesity related conditions.
LLY’s Stock Price, Valuation and Estimates
Lilly’s stock has declined 4.1% so far this year compared with the industry’s decrease of 0.2%.
From a valuation standpoint, Lilly’s stock is expensive. Going by the price/earnings ratio, LLY’s shares currently trade at 26.12 forward earnings, much higher than 14.60 for the industry. However, LLY’s stock is trading below its 5-year mean of 34.54.
The Zacks Consensus Estimate for 2025 has risen from $22.04 per share to $22.81 per share over the past 30 days, while that for 2026 has risen from $30.88 to $31.01 per share over the same timeframe.
LLY’s Zacks Rank
Lilly has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.