Eli Lilly (NYSE:LLY) announced positive results from a trial comparing tirzepatide to titrated insulin glargine in adults with type 2 diabetes.
Indianapolis-based Eli Lilly’s Surpass-4 clinical trial demonstrated that adults with type 2 diabetes and increased cardiovascular (CV) risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared to titrated insulin glargine.
Tirzepatide, a novel, investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes. Results from the Surpass-4 clinical trial of tirzepatide were published earlier this week in The Lancet.
According to a news release, at 52 weeks, the highest dose of tirzepatide led to an A1C reduction of 2.58% and reduced body weight by 25.8 lbs, a reduction of 13%. That compares to an A1C reduction of 1.44% and weight gain of 4.2 lbs (2.2%) in those treated with insulin glargine.
Newly published data from the treatment period after 52 weeks showed that participants who took tirzepatide maintained A1C and weight control for up to two years, with the overall safety profile over 104 weeks consistent with results measured at 52 weeks. Gastrointestinal side effects were most commonly reported as adverse events, usually occurring during the escalation period and decreasing over time.
Surpass-4 compared the safety and efficacy of three tirzepatide doses (5 mg, 10 mg and 15 mg) to titrated insulin glargine in 2,002 adults with type 2 diabetes with increased CV risk who were treated with between one and three oral antihyperglycemic medicines (metformin, a sulfonylurea or an SGLT-2 inhibitor). Of the randomized participants, 1,819 completed the primary 52-week visit and 1,706 completed the study on treatment.
The study achieved each of its primary and key secondary endpoints, with all three doses resulting in statistically significant and superior A1C and body weight reductions compared to insulin glargine.
“Given the progressive nature of type 2 diabetes, evaluating the positive efficacy results we have seen with tirzepatide over longer periods of time is important,” Eli Lilly VP of Product Development Dr. Jeff Emmick said in the release. “Throughout the length of Surpass-4, tirzepatide delivered robust improvements in blood glucose levels, significant weight loss and consistent safety results in adults with type 2 diabetes and increased cardiovascular risk.”