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Tirzepatide once a week for the treatment of obesity




Abstract

Background

Obesity is a chronic disease that results in significant global morbidity and mortality. The efficacy and safety of tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, in obese individuals are unknown.

Methods

In this phase 3 double-blind, randomized, controlled trial, we assigned 2539 adults with a body mass index (BMI; weight in kilograms divided by the square of height in meters) of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes, in the ratio of 1[ads1]: 1: 1: 1 to receive subcutaneous tirzepatide once weekly (5 mg, 10 mg or 15 mg) or placebo for 72 weeks, including a 20-week dose increase period. Coprimary endpoints were a percentage change in weight from baseline and a weight reduction of 5% or more. The treatment regimen assessment assessed effects independent of treatment interruptions in the population with the intention of treating.

Results

At baseline, the mean body weight was 104.8 kg, the mean BMI was 38.0, and 94.5% of the participants had a BMI of 30 or higher. The mean percentage change in weight at week 72 was -15.0% (95% confidence interval [CI], −15.9 to −14.2) with 5 mg weekly doses of tirzepatide, −19.5% (95% CI, −20.4 to −18.5) with 10 mg doses, and −20.9% (95% CI, −21.8 to −19.8%)) with 15 mg doses and -3.1% (95% CI, -4.3 to -1.9) with placebo (P <0.001 for all comparisons with placebo). The percentage of participants who had a weight reduction of 5% or more were 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92) and 91% (95% CI, 88 to 94) with 5%, respectively. mg, 10 mg and 15 mg tirzepatide and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of the participants in the 10 mg and 15 mg groups had a reduction in body weight of 20% or more, compared to 3% (95% CI, 1 to 5) in the placebo group (P <0.001 for all placebo comparisons). Improvements in all pre-specified cardiometabolic targets were observed with tirzepatide. The most common side effects with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation. Adverse reactions resulted in discontinuation of treatment in 4.3%, 7.1%, 6.2% and 2.6% of participants receiving 5 mg, 10 mg and 15 mg tirzepatide doses and placebo, respectively.

Conclusions

In this 72-week study in obese participants, 5 mg, 10 mg or 15 mg tirzepatide once a week resulted in significant and sustained reductions in body weight. (Supported by Eli Lilly; SURMOUNT-1 ClinicalTrials.gov Number, NCT04184622.)



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