SURMOUNT-2: Tirzepatide confers up to 15.7% weight loss for adults with obesity, diabetes
Click Here to Manage Email Alerts
Key takeaways:
- Adults receiving tirzepatide 10 mg or 15 mg lost more than 13% of their body weight at 72 weeks.
- A little more than half of adults in the tirzepatide 15 mg group achieved a 15% or greater weight loss.
Adults with overweight or obesity and type 2 diabetes achieved a mean weight loss of more than 13% after taking either 10 mg or 15 mg of tirzepatide for 72 weeks, according to topline results from the SURMOUNT-2 trial.
According to a company press release, SURMOUNT-2 was a randomized, double-blind, placebo controlled trial in which 938 adults with overweight or obesity plus type 2 diabetes were randomly assigned, 1:1:1, to receive tirzepatide 10 mg (Mounjaro, Eli Lilly), tirzepatide 15 mg or placebo for 72 weeks. Participants also ate a reduced-calorie diet and increased physical activity during the duration of the trial. The co-primary objectives were mean percentage change in body weight from baseline to 72 weeks and the percentage of adults achieving a 5% or greater body weight reduction.
Adults who received 10 mg of tirzepatide lost a mean 13.4% of their body weight at 72 weeks, and those taking 15 mg lost 15.7% of their body weight compared with a 3.3% weight loss for placebo. The percentage of adults who lost at least 5% of their body weight was 81.6% in the 10 mg tirzepatide group, 86.4% in the 15 mg group and 30.5% in the placebo group. Additionally, a 15% or greater weight loss was achieved by 51.8% of the 15 mg tirzepatide group, 41.4% of those taking 10 mg tirzepatide and 2.6% of the placebo group. Adults receiving tirzepatide also had a reduction in HbA1c that was similar to that seen in the SURPASS trials that analyzed tirzepatide for adults with type 2 diabetes.
The safety profile in SURMOUNT-2 was similar to those previously reported for the SURMOUNT and SURPASS trials. The most common adverse events were gastrointestinal-related and were mild to moderate in nature. Adults receiving tirzepatide were more likely to have nausea, diarrhea, vomiting and constipation compared with placebo. Treatment discontinuation due to adverse events was 3.8% in the 10 mg tirzepatide group and 7.4% in the 15 mg tirzepatide group.
The SURMOUNT-2 topline results add to previous evidence linking tirzepatide to weight loss among adults with overweight or obesity. As Healio previously reported, most adults with overweight or obesity receiving tirzepatide in the SURMOUNT-1 trial lost 16% or more of their body weight at 72 weeks.
In May 2022, the FDA approved tirzepatide to reduce HbA1c among adults with type 2 diabetes. According to the press release, Lilly plans to complete a submission to the FDA for tirzepatide as a treatment for adults with obesity or overweight with weight-related comorbidities, with regulatory action coming as early as late 2023.
“Obesity is a difficult-to-manage disease, and it's even more difficult for people living with type 2 diabetes,” Jeff Emmick, MD, PhD, senior vice president of product development for Lilly, said in a press release. “The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes.”
Results from SURMOUNT-2 are expected to be presented at the American Diabetes Association’s 83rd Scientific Sessions and submitted to a peer-reviewed journal.
“The ADA Standards of Care recommends personalized weight loss goals for those with diabetes and obesity with maximum benefit seen with weight reductions as high as 15% (as seen here) are achieved. This further supports the role of tirzepatide in the treatment of individuals with type 2 and obesity,” Robert A. Gabbay, MD, PhD, FACP, chief scientific and medical officer for the ADA, said in a statement about the results.
Perspective
Back to Top
SURMOUNT-2, a global and multi-center randomized controlled trial comparing the efficacy and safety of 10 mg and 15 mg tirzepatide to placebo as an adjunct to lifestyle in 938 adults with obesity or overweight and type 2 diabetes (baseline weight, 100.7 kg) over 72 weeks demonstrated no surprises. Average weight reductions were 13.4% on 10 mg and 15.7% on 15 mg tirzepatide compared with 3.3% on placebo, and 41.4% of participants taking 10 mg and 51.8% taking 15 mg achieved at least 15% body weight reduction compared with 2.6% of those taking placebo.
However, data from SURMOUNT-1 in patients living with obesity without type 2 diabetes (baseline weight, 104.8 kg) showed that mean weight loss was greater — 19.5% with 10 mg and 20.9% with 15 mg doses of tirzepatide vs. 3.1% with placebo. In addition, in SURMOUNT-1, 57% of subjects in the 10 mg and 15 mg groups combined lost 20% weight or more vs. 3% in the placebo group.
Thus, like other observations, almost all from historical data, the data on differential weight loss response to tirzepatide reflect a pattern of reduced weight loss in subjects with type 2 diabetes vs. those with obesity alone. Is this difference real, and if so, is this related to biological and/or behavioral differences between these two groups living with obesity?
Perspective
Back to Top
The advances in GLP-1-based medications for obesity treatment have been an exciting development over the past several years — none more intriguing than tirzepatide, a unique medication already approved for diabetes treatment. Last year's SURMOUNT-1 trial, which showed weight loss in the range of 20% in adults with obesity but without diabetes, was among the most impressive published research in the field of obesity treatment in decades.
These SURMOUNT-2 results, which evaluated weight loss outcomes in persons with excess weight and type 2 diabetes, were not only impressive at face value, but further reinforce the legitimacy of this medication as a central obesity treatment. With further research evaluating long-term outcomes in the pipeline, the future of obesity treatment for so many of those in need is bright.
Read more about
Click Here to Manage Email Alerts