Eli Lilly considers expanding weight-loss drug testing to individuals at risk of weight gain, regardless of BMI

Eli Lilly, the pharmaceutical giant known for its breakthrough weight-loss drugs, is exploring the potential for expanding the use of its medications beyond individuals living with obesity. The company is considering testing its popular drugs on individuals who are not currently overweight but are at risk of future weight gain. This move signals a possible broadening of the use of these medications to include those who fall within the healthy weight range but may face increased risks of certain health conditions related to weight gain.

Dave Ricks, the CEO of Eli Lilly, revealed in an interview with the Financial Times that the company is drafting plans to study the effects of its anti-obesity drugs, Mounjaro and Zepbound, on individuals with a body mass index (BMI) below the overweight category. Traditionally, clinical trials for weight-loss treatments focus on individuals with a BMI of 30 or higher (indicative of obesity), or those with a BMI of 27 and above who also experience weight-related health complications. However, Ricks suggested that this threshold may not be suitable for everyone.

“Maybe the cut-off point of [a BMI of] 27 we use in northern Europe and the US for entry into the studies isn’t appropriate. Maybe we should use [a BMI of] 25. Long term, should we look at health maintenance? Maybe we will,” Ricks stated.

Historically, trials of Eli Lilly’s injectable Zepbound and their experimental weight-loss pill orforglipron have centred around individuals classified as having overweight or obesity. Ricks, however, believes there may be merit in lowering the threshold, particularly in the case of orforglipron, which has demonstrated more moderate weight-loss results compared to injectable options.

Ricks further speculated that the drugs, part of the GLP-1 class of medications, could potentially be offered to individuals with a BMI below 25, which is classified as a healthy weight, but who are concerned about future health risks. He commented: “It’s possible that someone with a BMI of 24.9, who’s saying, ‘I’d like to not get diabetes in my life . . . or vascular dementia,’ or who is at an increased risk of stroke, could benefit from these treatments.”

The company’s interest in expanding the use of its drugs to include those with lower BMIs aligns with its broader strategy to develop the potential market for what is expected to be one of the most lucrative drug classes in history. According to projections by Goldman Sachs, GLP-1 drugs could generate as much as $130 billion annually at their peak. The global need for obesity treatment is significant, with an estimated 890 million adults living with obesity, while an additional 1.6 billion people are classified as overweight.

In addition to lowering the BMI cut-off for broader populations, Ricks highlighted the importance of tailoring these thresholds for specific ethnic groups. He noted, for example, that Pacific Islanders tend to develop type 2 diabetes at lower BMIs than other populations. “We should probably do work, and we are looking at work in those populations where the cut-off we use . . . is probably not appropriate for disease prevention,” he explained.

The extraordinary demand for Zepbound, alongside Novo Nordisk’s Wegovy, has led to both drugs being listed as in shortage by the US Food and Drug Administration (FDA). In response, both companies have invested heavily in expanding their production capabilities to meet the growing need.

Despite the high demand, Eli Lilly has been adamant in its stance against using Zepbound for cosmetic purposes. The company has publicly discouraged wealthy individuals and celebrities who are not overweight from using the drug off-label, arguing that scarce supplies should be prioritised for individuals living with diabetes and obesity who need the medication the most. In a notable move, Eli Lilly aired a primetime commercial during this year’s Academy Awards to emphasise that Zepbound is not intended “for the smaller dress or tux, for a big night, for vanity.”

“We’re not that comfortable with that right now,” Ricks said, referring to the off-label use of the drugs for cosmetic reasons. “Over time, we may develop a better understanding of that from a scientific sense . . . and certainly from a practical sense . . . but right now, I think what we can say is that’s inappropriate, and we have a very clear point of view on that.”

Eli Lilly’s exploration of expanding its trials to include individuals with a lower BMI may indicate a broader future application of weight-loss drugs, as the company continues to examine how best to utilise its treatments to prevent weight-related health conditions in people of all body types.