People who take weight-loss drugs hoping to achieve the impressive results observed in large clinical trials may need to adjust their expectations, a new study suggests.
In a real-world study of nearly 8,000 patients taking Novo Nordisk's Wegovy or Ozempic, or Eli Lilly's Zepbound or Mounjaro, the injectable drugs produced smaller average weight losses than in the closely monitored clinical trials that were the basis for their approval, researchers reported on Tuesday in Obesity.
The real-world patients took lower maintenance dosages and discontinued the drugs more often compared to participants in the clinical trials, which likely explains the lower weight losses, the researchers said.
The average patient in the study had clinically severe obesity, defined as a body mass index above 39. Participants began treatment with one of the drugs between 2021 and 2023. By December 2024, 20% had discontinued the medications within 3 months of starting them, and 32% had stopped the drugs between 3 and 12 months after starting.
After a year of treatment, the average weight reduction was 3.6% among those who discontinued their treatment early, compared to 6.8% for those who discontinued their treatment late. Those who did not discontinue treatment lost on average about 12% of their body weight.
In the pivotal clinical trials, patients lost about 15% to 20% of their body weight.
More than 80% of participants in the real-world study were on maintenance doses equal to or less than 1 milligram for semaglutide and equal to or less than 7.5 mg for tirzepatide. Semaglutide is the active ingredient in Wegovy and Ozempic, while tirzepatide is the main ingredient of Zepbound and Mounjaro.
Those who did not discontinue treatment and were on higher maintenance doses of the medications lost 13.7% of their body weight with semaglutide and 18.0% with tirzepatide, close to the average weight losses seen in a recent head-to-head clinical trial comparing the drugs.
About 17% of participants had pre-diabetes. In these patients, 33% of those who discontinued their treatment early achieved normal blood sugar levels, compared to 41% who discontinued their treatment late, and 67.9% who stayed on the drugs. The class of drugs to which these medicines belong were originally developed for type 2 diabetes.
"In our study, the majority of the patients with pre-diabetes experienced normal blood sugar levels when they continued their treatment," study leader Hamlet Gasoyan of the Cleveland Clinic in Ohio said in a statement.
"Type 2 diabetes is one of the most common complications of obesity, so diabetes prevention is very important. This study highlights that treatment discontinuation, especially early, negatively affects both weight and glycemic control outcomes."
The most common reasons for discontinuation of treatment included the cost of the medications and insurance coverage–related issues, side effects, and medication shortages.
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