Eli Lilly and Company has reported topline results from SURPASS-1 monotherapy clinical trial of its novel investigational molecule tirzepatide in adults with type 2 diabetes.
Data showed that after 40 weeks of treatment, tirzepatide led to superior A1C and body weight reductions from baseline as compared to placebo.
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that merges the actions of both incretins into a single novel molecule.
The 40-week, multi-centre, randomised, double-blind, parallel, placebo-controlled trial evaluated the efficacy and safety of tirzepatide 5mg/10mg/15mg as monotherapy versus placebo in adults with type 2 diabetes.
It enrolled 478 participants across the US, Mexico, India and Japan who randomly received either tirzepatide 5mg/10mg/15mg or placebo.
Data showed that using the efficacy estimand, the highest dose of tirzepatide led to an A1C reduction of 2.07% and reduced body weight by 9.5kg.
Furthermore, 51.7% of participants in this group had an A1C less than 5.7%.
Tirzepatide’s overall safety profile was similar to well-established GLP-1 receptor agonist class.
The primary and key secondary endpoints of SURPASS-1, the first Phase III trial of the comprehensive SURPASS programme, had superior A1C and mean body weight reductions verus placebo.
In addition, subjects in this monotherapy study had relatively lesser mean duration of diabetes of 4.7 years.
Eli Lilly Diabetes president Mike Mason said: “We are impressed by these initial results showing how tirzepatide performed in people with a relatively short duration of diabetes, and we look forward to seeing more results in people who are later in the course of diabetes in future studies from our robust SURPASS clinical trial programme.”