Eli Lilly and Company reported results from two late-phase clinical trials showing that patients with obesity were able to maintain weight loss after transitioning from higher doses of injectable incretin therapies to either its oral GLP-1 candidate Foundayo or a reduced dose of Zepbound.
Data from the SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN trials were presented at the 33rd European Congress on Obesity and published in The Lancet and Nature Medicine, respectively.
In the ATTAIN-MAINTAIN study, participants who switched from a maximum tolerated dose (MTD) of Wegovy (semaglutide) to Foundayo maintained nearly all of their prior weight loss after one year, regaining an average of 0.9 kg. Patients transitioning from Zepbound MTD to Foundayo regained an average of 5.0 kg over the same period.
SURMOUNT-MAINTAIN evaluated continued treatment with Zepbound following 60 weeks at MTD. Participants who remained on Zepbound MTD maintained all prior weight loss at week 112. Those who reduced their dose to 5 mg maintained most of their weight loss, regaining an average of 5.6 kg.
Across both trials, the primary endpoints were met, demonstrating that continued or modified therapy was superior to placebo in maintaining weight reduction. The findings support long-term treatment strategies for obesity, particularly in patients transitioning off higher-dose injectable therapies.
“Weight regain remains one of the biggest challenges in obesity care, and is often the result of treatment interruptions that cause biology to work against patients, undoing the progress they've made,” said Louis J. Aronne, M.D., a Lilly consultant and obesity specialist. “These medicines can be used for long-term maintenance today, and results from SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN provide additional evidence of their potential when switching from higher doses of injectable incretin therapy.”
Lilly executive vice president and president of cardiometabolic health Kenneth Custer, Ph.D., said the company is focused on expanding long-term treatment options. “Obesity is a chronic disease requiring long-term treatment, and patients need more options they can stay on for the long run,” he said.
Safety findings in both studies were consistent with prior Phase 3 data. In ATTAIN-MAINTAIN, the most common adverse events reported with Foundayo included nausea, constipation, vomiting and diarrhea, with discontinuation rates ranging from 4.8% to 7.2% depending on prior therapy. In SURMOUNT-MAINTAIN, commonly reported adverse events with Zepbound included diarrhea, vomiting and nausea, with discontinuation rates of 0% for MTD and 0.7% for the 5 mg dose during the maintenance period.
The results suggest that both oral and lower-dose maintenance strategies may help address long-term weight management challenges in obesity care following initial treatment with higher-dose incretin therapies.
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