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Eli Lilly and Company (LLY) on Tuesday reported positive results from two late-phase trials showing that its once-daily oral obesity drug Foundayo and lower doses of its injectable Zepbound helped patients successfully maintain most or all of their prior weight loss after switching from higher doses of injectable therapies.
The trial data addresses a major unmet need in obesity treatment: preventing weight regain once patients step down from higher doses or switch therapies. While Foundayo is Lilly’s FDA-approved oral weight loss pill, Zepbound is an injectable weight-loss treatment.
In the 112-week SURMOUNT-MAINTAIN trial, adults with obesity or overweight who had already lost substantial weight on Zepbound were randomized to continue on either the maximum tolerated dose of 10 mg or 15 mg of Zepbound, step down to 5 mg, or switch to placebo for an additional 52 weeks.
Participants who stayed on the maximum tolerated dose maintained virtually all of their weight loss. Those who stepped down to 5 mg maintained the vast majority of their loss, regaining only about 5.6 kg on average.
Both Zepbound doses met all primary and key secondary endpoints for weight maintenance versus placebo, Lilly said.
In the 52-week ATTAIN-MAINTAIN trial, patients who had reached a weight-loss plateau after treatment with Novo Nordisk’s weight loss drug Wegovy or higher-dose Zepbound were switched to once-daily oral Foundayo or placebo.
Patients switching from Wegovy to Foundayo maintained all but 0.9 kg of their prior weight loss on average. Patients switching from higher-dose Zepbound to Foundayo maintained all but 5.0 kg of their prior weight loss. Overall, participants on Foundayo preserved 78% to 82% of their previously achieved weight loss after one year, Lilly said.
Both drugs showed safety profiles consistent with earlier studies, Lilly said. Discontinuation rates due to adverse events were low across both trials, under 8% for Foundayo and under 1% for Zepbound.
On Stocktwits, retail sentiment around LLY stock stayed within the ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.
LLY stock has gained 31% over the past 12 months.
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