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Wednesday, December 9, 2020

Lilly's tirzepatide shows impressive A1C and weight reductions in type 2 diabetes

 

  • Eli Lilly (NYSE:LLY) announces top-line results from SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo in adults with type 2 diabetes.
  • Treatment differences for two estimands – efficacy and treatment-regimen – were evaluated for the three tirzepatide doses (5 mg, 10 mg and 15 mg) compared to placebo.
  • Using the efficacy estimand, the highest dose of tirzepatide led to an A1C reduction of 2.07% and reduced body weight by 9.5 kg (11.0%).
  • 51.7% of participants in this arm achieved an A1C less than 5.7% – the level seen in non-diabetic people, 87.9% of partticipants achieved A1C <7%.
  • In 10 and 5mg dose, A1C reduction was of 1.89% and 1.87%, respectively, with weight reduction of 7.8 and 7.0, respectively.
  • Percent of participants achieving A1C <5.7%: 30.5% (10 mg), 33.9% (5 mg) and 0.9% (placebo).
  • Percent of participants achieving A1C <7%: 91.5% (10 mg), 86.8% (5 mg) and 19.6% (placebo).
  • Study participants had a relatively short mean duration of diabetes of 4.7 years, a baseline A1C of 7.9% and a baseline weight of 85.9 kg.
  • The treatment-regimen estimand also led to statistically significant A1C and body weight reductions:
  • A1C reduction: -1.75% (5 mg), -1.71% (10 mg), -1.69% (15 mg), -0.09% (placebo).
  • Weight reduction: -6.3 kg (5 mg), -7.0 kg (10 mg), -7.8 kg (15 mg), -1.0 kg (placebo).
  • Percentage of participants achieving A1C <7%: 81.8% (5 mg), 84.5% (10 mg), 78.3% (15 mg), 23.0% (placebo).
  • Percentage of participants achieving A1C <5.7%: 30.9% (5 mg), 26.8% (10 mg), 38.4% (15 mg), 1.4% (placebo).
  • The overall safety profile of tirzepatide was similar to the GLP-1 receptor agonist class, with gastrointestinal side effects being the most commonly reported adverse events.
  • Treatment discontinuation rates were less than 7%.
  • The complete SURPASS-1 study data have not yet been evaluated but will be presented at the American Diabetes Association's 81st Scientific Sessions.
  • https://seekingalpha.com/news/3642823-lillys-tirzepatide-shows-impressive-a1c-and-weight-reductions-for-people-type-2-diabetes

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