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 or vascular dementia. 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 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.
