ADA 2023 NEWS: Tirzepatide achieves average weight reduction of 15.7% at highest dose in adults with obesity and type 2 diabetes

By Editor
28th June 2023
Obesity, Pharmaceutical Pharmacy Research Type 2 diabetes

Eli Lilly and Company’s tirzepatide led to superior weight reduction in people with overweight and type 2 diabetes, a trial evaluating the efficacy of the drug shows.

Detailed results from SURMOUNT-2 have revealed that 10 mg and 15 mg of tirzepatide met both co-primary endpoints and all key secondary endpoints compared to placebo for both estimands.

Those taking tirzepatide achieved a mean weight reduction of 13.4 per cent (29.8 lb. or 13.5 kg) on 10 mg and 15.7 per cent (34.4 lb. or 15.6 kg) on 15 mg compared to 3.3 per cent (7.0 lb. or 3.2 kg) on placebo for the efficacy estimand, which evaluates the treatment effect if all participants adhered to treatment.

For the efficacy estimand, 81.6 per cent (10 mg) and 86.4 per cent (15 mg) of people taking tirzepatide achieved at least five per cent body weight reduction, compared to 30.5 per cent of those taking placebo.

Both doses of tirzepatide achieved all key secondary endpoints at 72 weeks of treatment for the efficacy estimand, including:

  • Percentage of participants taking the 15 mg tirzepatide dose achieving ≥15 per cent and ≥20 per cent body weight reductions: 51.8 per cent (≥15 per cent reduction) and 34 per cent (≥20 per cent reduction), compared to 2.6 per cent and one per cent with placebo
  • Percentage of participants achieving A1C of <5.7 per cent: 55.3 per cent (10 mg) and 50.2 per cent (15 mg), compared to 2.8 per cent with placebo
  • Reduction in waist circumference: 11.2 cm (10 mg) and 13.8 cm (15 mg), compared to 3.4 cm with placebo
  • Reduction in fasting glucose: 49.2 mg/dL (10 mg) and 51.7 mg/dL (15 mg), compared to 2.4 mg/dL with placebo.

Pooled tirzepatide doses (10 mg and 15 mg) resulted in significantly greater improvements compared to placebo in systolic blood pressure (-7.2 mmHg vs. -1.0 mmHg), fasting triglycerides (-28.6 per cent vs. -5.8 per cent), HDL-cholesterol (8.2 per cent vs. 1.1 per cent) and non-HDL-cholesterol (-6.6 per cent vs. 2.3 per cent).

“People living with type 2 diabetes in many cases have been exposed to excess weight for years and often face increased difficulties in achieving weight loss results, typically losing 30% less weight than those who have obesity without type 2 diabetes. They need options to help overcome those challenges and achieve meaningful weight reductions,” said W. Timothy Garvey, MD, MACE, MABOM, Professor of Medicine at the University of Alabama at Birmingham (UAB), Director of the UAB Diabetes Research Center and Principal Investigator of SURMOUNT-2. “Tirzepatide not only helped people achieve body weight reductions of up to 15.7%, but also helped to significantly lower A1C without severe hypoglycemia and led to improvements in other cardiometabolic endpoints.”

Additionally, tirzepatide met the co-primary and all key secondary endpoints for the treatment-regimen estimand, which represents the average results of all study participants regardless of treatment adherence, including:

  • Mean body weight reductions: 12.8 per cent (10 mg), 14.7 per cent (15 mg), 3.2 per cent (placebo)
  • Percentage of participants achieving body weight reductions of ≥ five per cent: 79.2 per cent (10 mg), 82.8 per cent (15 mg), 32.5 per cent (placebo)
  • Percentage of participants achieving at least ≥20 per cent body weight reduction: 21.5 per cent (10 mg) and 30.8 per cent (15 mg), compared to one per cent with placebo
  • Percentage of participants achieving A1C of <5.7 per cent: 46 per cent (10 mg) and 48.6 per cent (15 mg), compared to 3.9 per cent with placebo.

The overall safety profile of tirzepatide was consistent with previously reported SURMOUNT and SURPASS trials and similar to incretin-based therapies approved for the treatment of obesity and overweight. The most commonly reported adverse events were gastrointestinal-related and were generally mild to moderate in severity, and usually occurred during the dose-escalation period.

For those treated with tirzepatide (10 mg and 15 mg, respectively), nausea (20.2 per cent, 21.9 per cent), diarrhoea (19.9 per cent, 21.5 per cent), vomiting (10.9 per cent, 13.2 per cent) and constipation (eight per cent, nine per cent) were more frequently reported compared to placebo (6.3 per cent [nausea], 8.9 per cent [diarrhoea], 3.2 per cent [vomiting], 4.1 per cent [constipation]).

“At Lilly, bringing new treatments to people with obesity is a priority and we are proud to share more evidence that solidifies our belief in tirzepatide as a treatment that will impact the way patients manage this disease,” said Mike Mason, Executive Vice President and President, Lilly Diabetes and Obesity. “With these results in hand, we have completed our submission for chronic weight management to the U.S. FDA. We look forward to the future of obesity care and the opportunity to bring potential new treatments, like tirzepatide, to people with obesity and overweight.”

Regulatory action for the U.S. submission for tirzepatide in adults with obesity, or overweight with weight-related comorbidities is expected by the end of 2023.

The data were presented during a symposium at the American Diabetes Association’s® (ADA) 83rd Scientific Sessions and were simultaneously published in The Lancet.

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