Eli Lilly Considers Expanding Weight-Loss Drug Trials to At-Risk Individuals with Lower BMI
Key Insights
Eli Lilly is considering lowering the BMI threshold for its weight-loss drug trials, potentially including individuals with a BMI of 25, according to CEO Dave Ricks.
The company may expand trials for drugs like Zepbound and orforglipron to those with a BMI below 25 who are at risk of conditions like diabetes (search) or vascular dementia (search).
This move addresses the need for tailored BMI cut-offs for different ethnic groups, such as Pacific Islanders, who are prone to type-two diabetes (search) at lower BMIs.
Eli Lilly is exploring the possibility of expanding its weight-loss drug trials to include individuals who are at risk of gaining weight but not currently classified as overweight. This strategic shift, as indicated by CEO Dave Ricks, involves reevaluating the Body Mass Index (BMI) threshold for participant inclusion in clinical trials for drugs like Mounjaro and Zepbound.
Lowering the BMI Threshold
Currently, Eli Lilly's trials typically require a BMI of 27 or higher in the U.S. and northern Europe. Ricks suggested that a BMI of 25 might be a more appropriate cut-off, particularly for trials involving orforglipron, an experimental weight-loss pill that produces more modest weight loss compared to Zepbound. This adjustment could broaden the scope of individuals eligible for these trials.
Addressing At-Risk Populations
The expansion may also encompass individuals with a BMI below 25 who are considered to have a healthy weight but are at risk of developing conditions such as diabetes (search) or vascular dementia (search). This approach recognizes that certain populations may benefit from early intervention with weight-loss medications to mitigate the risk of these associated health issues.
Ethnic Considerations
Ricks emphasized the importance of considering different BMI cut-offs for specific ethnic groups, citing Pacific Islanders as an example. These populations are known to develop type-two diabetes (search) earlier and at a lower BMI compared to other groups. Tailoring BMI thresholds to reflect these differences could enhance the effectiveness and relevance of clinical trials.
Market Context and Demand
The demand for Zepbound and Novo Nordisk's Wegovy has surged, leading to supply shortages. Both companies are investing heavily in increasing manufacturing capacity to meet this demand. Eli Lilly has actively discouraged the off-label use of Zepbound for cosmetic purposes, emphasizing the need to prioritize its use for diabetic and obese patients.
Competition and Market Challenges
Eli Lilly's stock has experienced significant growth due to the success of its weight-loss medications. However, the company faces competition from knockoff drugs and the challenges of navigating market dynamics after a substantial rally.