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Eli Lilly's Next-Generation Obesity Drug Secures First Phase III Win
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Key Takeaways
Eli Lilly's TRIUMPH-4 trial showed retatrutide met all primary and key secondary endpoints.
The drug delivered substantial weight loss and knee pain reduction across both tested doses.
Higher adverse events led to increased discontinuations as Eli Lilly advances seven more studies.
Shares of Eli Lilly (LLY - Free Report) rose nearly 2% on Thursday after the company announced that a late-stage study evaluating its experimental once-weekly weight-loss drug, retatrutide, met all primary and key secondary endpoints.
This study, called TRIUMPH-4, evaluated two doses (9 mg and 12 mg) of the drug for 68 weeks against placebo in adults with obesity or overweight and knee osteoarthritis (OA), and without diabetes. Ei 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.
Under the efficacy estimand, Eli Lilly reported that patients on the 12 mg dose lost an average of 28.7% of their body weight, while those on the 9 mg dose lost 26.4%. In comparison, patients on placebo lost 2.1% of their body weight. For the other co-primary endpoint of improvement in knee pain, retatrutide achieved a reduction of 74-76% across both doses compared with the 40.3% reported in the placebo group.
Concerning the treatment-regimen estimand, patients on the 12 mg dose lost an average of 23.7% of their body weight while the 9 mg dose generated a 20% reduction. In comparison, patients on placebo achieved a 4.6% reduction. For the other endpoint, both retatrutide doses delivered a 62-67% reduction in knee pain compared with 35.1% in the placebo arm.
However, patients treated with retatrutide also reported higher rates of adverse effects than the placebo group. Most common symptoms included nausea, constipation, vomiting and dysesthesia, which led to higher dropouts in the study. Eli Lilly reported that the discontinuation rates due to adverse events stood at 12.2% for the 9 mg drug dose and 18.2% for the 12 mg dose compared to 4.0% in the placebo group.
The TRIUMPH-4 is the first of the eight late-stage studies evaluating retatrutide across various cardiometabolic indications, including obesity with at least one weight-related medical problem, type II diabetes, sleep apnea and chronic low back pain. Data from the remaining seven studies are expected throughout next year.
LLY Stock Performance
Investors broadly welcomed the results, which surpassed early expectations and renewed optimism for retatrutide’s potential across multiple indications. Some have also highlighted the drug’s distinct mechanism versus Eli Lilly’s leading GLP-1 therapy, Zepbound. Retatrutide activates three hormone receptors — GLP-1, GIP and glucagon — compared with Zepbound, which targets GLP-1 and GIP. By comparison, Novo Nordisk’s (NVO - Free Report) obesity drug Wegovy activates only GLP-1.
Year to date, shares of Eli Lilly have rallied 31% compared with the industry‘s 15% growth.
Image Source: Zacks Investment Research
Competition Escalates in the Obesity Space
According to research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. Eli Lilly and Novo Nordisk presently dominate this space with their respective injectables.
Eli Lilly and Novo Nordisk are racing to introduce oral weight-loss pills. NVO has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected before this year’s end. It is also developing several next-generation candidates in its obesity pipeline, including CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist).
LLY is investing broadly in obesity and has several new molecules currently in clinical development, with a range of oral and injectable medications using different mechanisms of action. Another key late-stage asset is orforglipron, its once-daily oral GLP-1, which remains on track for a regulatory submission before the end of 2025 — positioning it for a potential launch next year.
Several other companies, like Viking Therapeutics (VKTX - Free Report) , are also making rapid progress in the obesity space. In June, 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 by early 2026.
Image: Bigstock
Eli Lilly's Next-Generation Obesity Drug Secures First Phase III Win
Key Takeaways
Shares of Eli Lilly (LLY - Free Report) rose nearly 2% on Thursday after the company announced that a late-stage study evaluating its experimental once-weekly weight-loss drug, retatrutide, met all primary and key secondary endpoints.
This study, called TRIUMPH-4, evaluated two doses (9 mg and 12 mg) of the drug for 68 weeks against placebo in adults with obesity or overweight and knee osteoarthritis (OA), and without diabetes. Ei 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.
Under the efficacy estimand, Eli Lilly reported that patients on the 12 mg dose lost an average of 28.7% of their body weight, while those on the 9 mg dose lost 26.4%. In comparison, patients on placebo lost 2.1% of their body weight. For the other co-primary endpoint of improvement in knee pain, retatrutide achieved a reduction of 74-76% across both doses compared with the 40.3% reported in the placebo group.
Concerning the treatment-regimen estimand, patients on the 12 mg dose lost an average of 23.7% of their body weight while the 9 mg dose generated a 20% reduction. In comparison, patients on placebo achieved a 4.6% reduction. For the other endpoint, both retatrutide doses delivered a 62-67% reduction in knee pain compared with 35.1% in the placebo arm.
However, patients treated with retatrutide also reported higher rates of adverse effects than the placebo group. Most common symptoms included nausea, constipation, vomiting and dysesthesia, which led to higher dropouts in the study. Eli Lilly reported that the discontinuation rates due to adverse events stood at 12.2% for the 9 mg drug dose and 18.2% for the 12 mg dose compared to 4.0% in the placebo group.
The TRIUMPH-4 is the first of the eight late-stage studies evaluating retatrutide across various cardiometabolic indications, including obesity with at least one weight-related medical problem, type II diabetes, sleep apnea and chronic low back pain. Data from the remaining seven studies are expected throughout next year.
LLY Stock Performance
Investors broadly welcomed the results, which surpassed early expectations and renewed optimism for retatrutide’s potential across multiple indications. Some have also highlighted the drug’s distinct mechanism versus Eli Lilly’s leading GLP-1 therapy, Zepbound. Retatrutide activates three hormone receptors — GLP-1, GIP and glucagon — compared with Zepbound, which targets GLP-1 and GIP. By comparison, Novo Nordisk’s (NVO - Free Report) obesity drug Wegovy activates only GLP-1.
Year to date, shares of Eli Lilly have rallied 31% compared with the industry‘s 15% growth.
Image Source: Zacks Investment Research
Competition Escalates in the Obesity Space
According to research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. Eli Lilly and Novo Nordisk presently dominate this space with their respective injectables.
Eli Lilly and Novo Nordisk are racing to introduce oral weight-loss pills. NVO has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected before this year’s end. It is also developing several next-generation candidates in its obesity pipeline, including CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist).
LLY is investing broadly in obesity and has several new molecules currently in clinical development, with a range of oral and injectable medications using different mechanisms of action. Another key late-stage asset is orforglipron, its once-daily oral GLP-1, which remains on track for a regulatory submission before the end of 2025 — positioning it for a potential launch next year.
Several other companies, like Viking Therapeutics (VKTX - Free Report) , are also making rapid progress in the obesity space. In June, 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 by early 2026.
Last month, 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 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. Earlier this week, Pfizer has declared 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.