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.
Tirzepatide is in numerous trials for indications from cardiovascular outcomes to metabolic dysfunction-associated steatohepatitis (MASH) as Lilly works to increase the megablocksbuster drug’s market territory.
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.