Lilly's investigational tirzepatide led to greater improvements in liver fat content compared to insulin degludec in adults with type 2 diabetes in SURPASS-3 MRI sub-study
Participants taking tirzepatide 10 mg experienced 47.11 per cent relative reduction in liver fat content compared to 11.17 per cent for insulin degludec
Volume of abdominal adipose tissue decreased with tirzepatide, compared to an increase with insulin degludec
TORONTO, Oct. 1, 2021 /CNW/ - Tirzepatide led to greater improvements in liver fat content and abdominal adipose tissue compared to titrated insulin degludec in adults with type 2 diabetes in an MRI sub-study of Eli Lilly and Company's phase 3 SURPASS-3 clinical trial.1 The results were presented at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting in an EASD sponsored symposium.
The MRI (magnetic resonance imaging) sub-study achieved its primary and secondary endpoints. As evaluated by MRI scans, the sub-study showed all three doses of tirzepatide (5 mg, 10 mg, 15 mg) led to greater reductions in liver fat content compared to insulin degludec and reductions in volume of visceral adipose tissue and abdominal subcutaneous adipose tissue compared to increases in volume of both measurements with insulin degludec at 52 weeks.
"Increased ectopic fat – such as liver fat or visceral adipose tissue – is commonly seen in adults with type 2 diabetes and is associated with an inflammatory response and increased cardiometabolic risk," said Amalia Gastaldelli, Ph.D., Research Director of Cardiometabolic Risk Unit, Institute of Clinical Physiology, CNR, Pisa Italy. "We are encouraged by the robust reductions in liver fat content and abdominal adipose tissue observed with all three doses of tirzepatide in this population of adults with type 2 diabetes and elevated liver fat content."
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that 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.
SURPASS-3 was a 52-week, multi-centre, randomized, phase 3, open-label trial evaluating the efficacy and safety of tirzepatide compared to titrated insulin degludec in adults with type 2 diabetes who have inadequate glycemic control on stable doses of metformin with or without an SGLT-2 inhibitor. Study participants were insulin-naïve and had a mean duration of diabetes of 8.4 years, a baseline A1C of 8.17 per cent and a baseline weight of 94.3 kg.
The SURPASS-3 MRI sub-study compared the effect of tirzepatide to titrated insulin degludec on liver fat content (LFC), volume of visceral adipose tissue (VAT) and abdominal subcutaneous adipose tissue (ASAT) in 296 participants as evaluated by MRI scans at baseline and at 52 weeks. The subpopulation of adults with type 2 diabetes who participated in this sub-study had an overall baseline LFC of 15.7 per cent.
Results among participants taking tirzepatide at 52 weeks showed:
- Greater absolute reduction from baseline in LFC for pooled 10 mg and 15 mg arms (-8.09 per cent from 15.67 per cent at baseline) compared to insulin degludec (-3.38 per cent from 16.58 per cent at baseline), the primary endpoint.
- Greater relative reduction from baseline in LFC (29.78 per cent -47.11 per cent across the three doses) compared to 11.17 per cent for insulin degludec.
- The majority of participants taking tirzepatide achieved at least a 30 per cent reduction in LFC from baseline (66.9 per cent -81.4 per cent across the three doses) compared to a third of those taking insulin degludec (32.12 per cent).
- Up to -1.65 liter (L) reduction from baseline of 6.81 L in VAT (15 mg) and -2.25 L reduction from baseline of 10.21 L in ASAT (10 mg) compared to increases with insulin degludec (+0.38 L from 6.34 L baseline and +0.63 L from 10.04 L baseline respectively
"In this study, we found that more than twice as many participants taking tirzepatide experienced greater than 30 per cent reduction in liver fat content compared to those taking insulin degludec,"said Laura Fernández Landó, M.D., senior medical director, Lilly Diabetes. "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."
About tirzepatide
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP and GLP-1 are incretin molecules that increase insulin secretion postprandially. Tirzepatide is in phase 3 development for blood glucose management in adults with type 2 diabetes and for chronic weight management. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).
About Diabetes
Approximately 11 million Canadians are living with diabetes or prediabetes. Roughly 90 per cent of people living with diabetes have type 2 diabetes.2
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more.
About Eli Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about tirzepatide as a potential treatment for patients with diabetes and reflects Lilly's current beliefs. However, as with any such undertakings, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that tirzepatide will prove to be a safe and effective treatment for diabetes, that tirzepatide will receive regulatory approvals or authorizations, or be commercially successful. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
REFERENCES
1 Cusi, K. The effects of tirzepatide on liver fat content and abdominal adipose tissue in patients with type 2 diabetes (SURPASS-3 MRI). Session S42a. Presented virtually at the 57th European Association for the Study of Diabetes Annual Meeting; September 27- October 1. |
2 Diabetes Canada – last accessed on October 1, 2021. LINK |
SOURCE Eli Lilly Canada Inc.
Media Contact: Ethan Pigott, [email protected], 416-770-5843
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