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Treatment with tirzepatide led to superior weight loss in adults with type 2 diabetes with obesity or who are overweight compared with placebo, according to phase 3 data.
Tirzepatide is a once-weekly, dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist that integrates the actions of both incretins into a single molecule.
The multicenter, randomized, double-blind, parallel, placebo-controlled SURMOUNT-2 trial (ClinicalTrials.gov Identifier: NCT04657003) evaluated tirzepatide as an adjunct to a reduced-calorie diet and increased physical activity in 938 adults with type 2 diabetes who have obesity or are overweight. The mean baseline body weight of study participants was 222lb (100.7kg).
Patients were randomly assigned 1:1:1 to receive either tirzepatide 10mg, 15mg, or placebo subcutaneously once weekly for 72 weeks. The coprimary endpoints were the percent change from baseline in body weight and the proportion of patients who achieved at least 5% body weight reduction at 72 weeks.
The efficacy estimand results demonstrated that treatment with tirzepatide was associated with the following body weight reductions at week 72 vs placebo:
- Average body weight reductions: 13.4% (29.8lb or 13.5kg) on 10mg, 15.7% (34.4lb or 15.6kg) on 15mg vs 3.3% (7.0lb or 3.2kg) on placebo.
- Percentage of patients achieving at least 5% body weight reduction: 81.6% (10mg), 86.4% (15mg) vs 30.5% (placebo).
- Percentage of patients achieving at least 15% body weight reduction: 41.4% (10mg), 51.8% (15mg) vs 2.6% (placebo).
For the treatment-regimen estimand, tirzepatide was associated with the following body weight reductions at week 72 vs placebo:
- Average body weight reductions: 12.8% (10mg), 14.7% (15mg) vs 3.2% (placebo)
- Percentage of patients achieving at least 5% body weight reduction: 79.2% (10mg), 82.7% (15mg) vs 32.5% (placebo).
- Percentage of patients achieving at least 15% body weight reduction: 39.7% (10mg), 48.0% (15mg) vs 2.7% (placebo).
The safety profile of tirzepatide was similar to previously reported data from the SURMOUNT and SURPASS trials and to incretin-based therapies approved for the treatment of obesity. The most common adverse events reported were gastrointestinal-related (nausea, diarrhea, vomiting, constipation) and were generally mild to moderate in severity.
“Obesity is a difficult-to-manage disease, and it’s even more difficult for people living with type 2 diabetes,” said Jeff Emmick, MD, PhD, senior vice president, product development, Lilly. “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.” The Company expects to complete the US regulatory submission for the weight management indication in the coming weeks. Tirzepatide is currently marketed under the brand name Mounjaro for the treatment of type 2 diabetes.
