Eli Lilly Doubles Down with Positive Results in T2D and Alopecia Trials
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Eli Lilly’s tirzepatide is demonstrating robust responses against type 2 diabetes. In two separate studies, the once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist showed promise as a treatment for this growing health concern.
This morning, Indianapolis-based Eli Lilly presented data from two tirzepatide sub-studies at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting. Data from a sub-study in the Phase III SURPASS-3 trial showed that tirzepatide led to more significant improvements in liver fat content and abdominal adipose tissue compared to titrated insulin degludec in adults with type 2 diabetes. Those results were based on magnetic resonance imaging (MRI) scans.
The study showed that three different dosing levels of tirzepatide (5 mg, 10 mg, 15 mg) led to greater reductions in liver fat content compared to insulin. Increased liver fat is commonly seen in type 2 diabetes patients. It is typically associated with an inflammatory response and increases cardiometabolic risks in patients.
The SURPASS-3 MRI sub-study compared the effect of tirzepatide to titrated insulin degludec on liver fat content, visceral adipose tissue volume and abdominal subcutaneous adipose tissue. According to Eli Lilly, the population of adults with type 2 diabetes who participated in this sub-study had an overall baseline liver fat content of 15.7%.
The Eli Lilly drug also led to reductions in visceral adipose tissue and abdominal subcutaneous adipose tissue compared to increases in the volume of both measurements with insulin at 52 weeks.
Laura Fernandez Lando, M.D., senior medical director of Lilly Diabetes, said that in the sub-study, they found that more than twice as many participants taking tirzepatide experienced a reduction of at least 30% liver fat content compared to those patients who received degludec.
“The results provide us with a deeper understanding of the potential metabolic benefits of tirzepatide in adults with type 2 diabetes and we look forward to continuing to study the effects of tirzepatide beyond glucose and weight control alone,” Lando said in a statement.
In a continuous glucose monitoring (CGM) sub-study of the SURPASS-3 trial, Lilly reported that participants who received the highest dose of tirzepatide experienced 91.2% time in range and 72.6% time in the tight target range. The international consensus for the time in range recommends a target of greater than 70% time in range for most people with diabetes as well as a target of less than 4% time below range and less than 25% time above range.
Eli Lilly said all three tirzepatide dose levels led to more time in the tight target range, improved glycemic variability and numerically less time in hypoglycemia compared to titrated degludec.
Richard Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet, noted that the CGM data collected in the sub-study demonstrates that tirzepatide provided patients with steadier levels of blood glucose levels throughout the day.
“Improving glycemic variability, increasing time in range and reducing time below range are important metrics in the management of type 2 diabetes because they reflect glucose control throughout the day, offering context beyond the three-month average of A1C,” Bergenstal said in a statement.
In addition to the type-2 diabetes news, Eli Lilly also announced data from a Phase III study of Olumiant (baricitinib) that demonstrated its efficacy in re-growing hair in adults with severe alopecia areata. The company said that significant improvements in the regrowth of hair were seen at 36 weeks compared to placebo in patients who received both a 2 mg and 4 mg dose of Olumiant.
The company reported that a greater proportion of patients who received the 4 mg dose achieved full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair coverage at 36 weeks. These were key secondary endpoints of the studies.
There are no approved systemic therapies for alopecia areata, an autoimmune disease that can cause extreme and patchy hair loss on the scalp, face and other areas of the body.