Eli Lilly and Company has unveiled positive results from the Phase 3 SURMOUNT-1 study of tirzepatide treatment in adults with pre-diabetes and obesity or overweight condition.
Tirzepatide is the active ingredient in Lilly’s diabetes drug Mounjaro and weight-loss treatment Zepbound. It is also the first and only approved dual GIP and GLP-1 receptor agonist.
SURMOUNT-1, which enrolled 1,032 adults with prediabetes and obesity, is said to be the longest tirzepatide study to date.
The multi-centre, randomised, double-blind, parallel, placebo-controlled trial compared the efficacy and safety of the active ingredient to the placebo.
Over 176 weeks, weekly tirzepatide injections (pooled 5 mg, 10 mg, 15 mg doses) showed a 94% reduction in the risk of developing type 2 diabetes in adults with pre-diabetes and obesity or overweight.
The treatment also showed sustained weight loss of 22.9% with the 15 mg dose.
Lilly product development senior vice president Jeff Emmick said: “In the SURMOUNT-1 three-year study of tirzepatide, an average weight reduction of up to 22.9% was accompanied by a hazard ratio of 0.06 for progression to type 2 diabetes.
“This translates to a risk reduction of 94% and a number needed to treat of nine to prevent one case of diabetes.”
The study showed that the GIP and GLP-1 receptor agonist improved glycaemic control, cardiometabolic risk factors, and health-related quality of life, with benefits sustained through 176 weeks.
A post hoc analysis suggested that weight loss accounted for about half of tirzepatide’s impact on delaying type 2 diabetes onset.
After 193 weeks, tirzepatide’s safety and tolerability profile remained consistent with prior SURMOUNT-1 results and other long-term studies for weight reduction and maintenance.
Tirzepatide was approved by the US Food and Drug Administration (FDA) as Mounjaro for type 2 diabetes in May 2022, and as Zepbound in November 2023.
It is also marketed as Mounjaro in select global markets for obesity with comorbid conditions.
Ongoing studies of the dual GIP and GLP-1 receptor agonist are exploring its effects on chronic kidney disease (CKD) and obesity-related morbidity/mortality (MMO).
Lilly has submitted data for tirzepatide in obstructive sleep apnoea (OSA) and obesity to the FDA and other regulatory agencies.
Positive data for heart failure with preserved ejection fraction (HFpEF) and obesity will be submitted later this year. These results were announced in August 2024.
