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.
LLY's Next-Gen Obesity Drug Meets Goal in First Phase III Study for T2D
Read MoreHide Full Article
Key Takeaways
Eli Lilly's Phase III TRANSCEND-T2D-1 met its primary goal in adults with type 2 diabetes.
LLY's retatrutide cut A1C by up to 2% and delivered up to 16.8% weight loss in the study.
The drug targets three receptors and is being tested across multiple cardiometabolic conditions.
Eli Lilly (LLY - Free Report) announced positive top-line results from a late-stage study evaluating its experimental once-weekly weight-loss drug, retatrutide, in adults with type II diabetes (T2D)
This study, called TRANSCEND-T2D-1, evaluated three doses (4 mg, 9 mg and 12 mg) of the drug for 40 weeks against placebo in adults with T2D and inadequate glycemic control with diet and exercise alone. Eli Lilly reported results using two approaches — an efficacy estimand, which reflects outcomes in patients who stayed on treatment throughout the study period and a treatment-regimen estimand, which incorporates data from patients who discontinued treatment.
The study achieved its primary endpoint. Under the efficacy estimand, patients who took retatrutide achieved A1C reduction (a measure of blood sugar levels) by an average of 1.7% to 2% compared to 0.8% in the placebo group. Across the treatment-regimen estimand, patients receiving the drug reduced A1C by an average of 1.7% to 1.9%, versus 0.8% in the placebo group.
For a key secondary goal, patients who took the drug lost up to 16.8% of their body weight using the efficacy estimand, compared to 2.5% in the placebo group. Under the treatment-regimen estimand, patients lost 15.3% of their body weight, compared to 2.6% in the placebo group. LLY noted that the weight loss continued through the end of the treatment period.
The TRANSCEND-T2D-1 is the second of the eight late-stage studies evaluating retatrutide across various cardiometabolic indications, including T2D, obesity with at least one weight-related medical problem, sleep apnea and chronic low back pain. In December, Eli Lilly reported top-line data from the late-stage TRIUMPH-4 study, which evaluated the drug in adults with obesity or overweight and knee osteoarthritis, and without diabetes. Results from this study showed that retatrutide lowered weight by up to an average of 28.7%. Data from some of the remaining studies are expected later this year.
Retatrutide activates three hormone receptors — GLP-1, GIP and glucagon — compared with the company’s approved obesity drug Zepbound, which targets GLP-1 and GIP. In comparison, Novo Nordisk’s (NVO - Free Report) obesity drug Wegovy activates only GLP-1.
Eli Lilly’s Stock Movement
As seen in the chart below, Eli Lilly’s shares have underperformed the industry year to date.
Image Source: Zacks Investment Research
Competition Escalates in the Obesity Space
The obesity market has garnered significant attention over the past few years due to the sizeable and still underpenetrated market opportunity. Currently, Eli Lilly and Novo Nordisk dominate this space with their respective injectable therapies.
Eli Lilly and Novo Nordisk are racing to introduce oral weight-loss pills. In late December, the FDA approved an oral version of Wegovy. The drug was commercially launched in early January. The approval made Wegovy the first GLP-1 therapy available as a pill for weight management, offering a needle-free alternative that could expand patient adoption. A regulatory filing for Eli Lilly’s obesity pill orforglipron is currently under review by the FDA, with a final decision expected soon.
Several other companies, like Viking Therapeutics (VKTX - Free Report) , are making rapid progress in the obesity space. Last year, VKTX started two late-stage studies evaluating the subcutaneous formulation of its investigational obesity drug, VK2735. While one of these studies recently completed enrolment at a rapid pace, the company expects to complete enrolment in the other study soon.
View the Zacks #1 Rank List
Image: Bigstock
LLY's Next-Gen Obesity Drug Meets Goal in First Phase III Study for T2D
Key Takeaways
Eli Lilly (LLY - Free Report) announced positive top-line results from a late-stage study evaluating its experimental once-weekly weight-loss drug, retatrutide, in adults with type II diabetes (T2D)
This study, called TRANSCEND-T2D-1, evaluated three doses (4 mg, 9 mg and 12 mg) of the drug for 40 weeks against placebo in adults with T2D and inadequate glycemic control with diet and exercise alone. Eli Lilly reported results using two approaches — an efficacy estimand, which reflects outcomes in patients who stayed on treatment throughout the study period and a treatment-regimen estimand, which incorporates data from patients who discontinued treatment.
The study achieved its primary endpoint. Under the efficacy estimand, patients who took retatrutide achieved A1C reduction (a measure of blood sugar levels) by an average of 1.7% to 2% compared to 0.8% in the placebo group. Across the treatment-regimen estimand, patients receiving the drug reduced A1C by an average of 1.7% to 1.9%, versus 0.8% in the placebo group.
For a key secondary goal, patients who took the drug lost up to 16.8% of their body weight using the efficacy estimand, compared to 2.5% in the placebo group. Under the treatment-regimen estimand, patients lost 15.3% of their body weight, compared to 2.6% in the placebo group. LLY noted that the weight loss continued through the end of the treatment period.
The TRANSCEND-T2D-1 is the second of the eight late-stage studies evaluating retatrutide across various cardiometabolic indications, including T2D, obesity with at least one weight-related medical problem, sleep apnea and chronic low back pain. In December, Eli Lilly reported top-line data from the late-stage TRIUMPH-4 study, which evaluated the drug in adults with obesity or overweight and knee osteoarthritis, and without diabetes. Results from this study showed that retatrutide lowered weight by up to an average of 28.7%. Data from some of the remaining studies are expected later this year.
Retatrutide activates three hormone receptors — GLP-1, GIP and glucagon — compared with the company’s approved obesity drug Zepbound, which targets GLP-1 and GIP. In comparison, Novo Nordisk’s (NVO - Free Report) obesity drug Wegovy activates only GLP-1.
Eli Lilly’s Stock Movement
As seen in the chart below, Eli Lilly’s shares have underperformed the industry year to date.
Image Source: Zacks Investment Research
Competition Escalates in the Obesity Space
The obesity market has garnered significant attention over the past few years due to the sizeable and still underpenetrated market opportunity. Currently, Eli Lilly and Novo Nordisk dominate this space with their respective injectable therapies.
Eli Lilly and Novo Nordisk are racing to introduce oral weight-loss pills. In late December, the FDA approved an oral version of Wegovy. The drug was commercially launched in early January. The approval made Wegovy the first GLP-1 therapy available as a pill for weight management, offering a needle-free alternative that could expand patient adoption. A regulatory filing for Eli Lilly’s obesity pill orforglipron is currently under review by the FDA, with a final decision expected soon.
Several other companies, like Viking Therapeutics (VKTX - Free Report) , are making rapid progress in the obesity space. Last year, VKTX started two late-stage studies evaluating the subcutaneous formulation of its investigational obesity drug, VK2735. While one of these studies recently completed enrolment at a rapid pace, the company expects to complete enrolment in the other study soon.
Last year, Pfizer (PFE - Free Report) closed the acquisition of obesity drug developer Metsera for around $10 billion, after a heated bidding war against Novo Nordisk. The Metsera acquisition has brought Pfizer back into the lucrative obesity space by adding the latter’s four novel clinical-stage incretin and amylin programs, which are expected to generate billions of dollars in peak sales. In December, Pfizer announced that it is in-licensing exclusive global rights to develop and market an oral small molecule GLP-1 drug from a leading Chinese drugmaker.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
LLY’s Zacks Rank
Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.