After recently reporting soaring sales of its diabetes franchise, Eli Lilly is back with more data on its GLP-1/GIP dual agonist tirzepatide. In a Phase 3 trial, the drug reduced the risk of developing type 2 diabetes by 94% in adults with pre-diabetes who have obesity or are overweight.
The drug — marketed in the US as Mounjaro for diabetes and Zepbound for weight loss — also showed a 22.9% decrease in body weight with the highest dose at the end of 176 weeks of treatment. The three-year, 1,032-patient trial, called SURMOUNT-1, is the longest completed trial of tirzepatide so far, according to Lilly. Patients were randomized to either 5 mg, 10 mg or 15 mg of the drug or placebo.
Jeff Emmick“These data reinforce the potential clinical benefits of long-term therapy for people living with obesity and pre-diabetes,” Lilly SVP of product development Jeff Emmick wrote in a statement.
The trial hit the secondary endpoints, with tirzepatide showing a “significant reduction” in the risk of progression to type 2 diabetes, earning a p<0.0001. For the two lower doses, the average weight reductions were 15.4% and 19.9%.
On par with previous studies and the drug class overall, the most common adverse events were gastrointestinal issues, including diarrhea, nausea, constipation and vomiting.
The company said it plans to discuss with regulators; however, Leerink Partners analysts wrote in a Tuesday note that “it is unclear if the company can file for approval for [type 2 diabetes] prevention even though the company incorporated robust ADA guidelines in its trial enrollment criteria.”
“We currently assume that the data is simply added to tirzepatide’s label,” they added. “If [Lilly] is able to secure a formal indication, it would represent material upside.”
Tirzepatide is in numerous trials for indications from heart failure outcomes to metabolic dysfunction-associated steatohepatitis (MASH) as Lilly works to increase the megablocksbuster drug’s market territory. The next readout of the drug likely will be the head-to-head weight loss trial, called SURMOUNT-5, that pits tirzepatide against Novo Nordisk’s semaglutide, which is marketed as Wegovy for weight loss.
Novo does not currently have a trial for semaglutide in prediabetes, but a 2023 post-hoc analysis in the research journal Obesity examining several trials found that semaglutide might lower the 10-year risk of developing type 2 diabetes by as much as 60% in people with obesity or overweight, including in patients with prediabetes.
The company revealed cardiovascular outcomes data in August, showing that it reduces the risk of heart failure outcomes like a heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death by 38% compared to placebo in a Phase 3 trial. Tirzepatide also won out in MASH in a Phase 2 trial earlier this year.
Tirzepatide has pulled in considerable revenue for Lilly: Zepbound brought in $1.2 billion in the second quarter while Mounjaro made just over $3 billion.
Editor’s Note: This story has been updated to include analyst commentary.