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Is Foundayo safe long term? What the clinical trial data actually shows
Clinical trials found gastrointestinal side effects in 60% to 80% of patients, while long-term safety data beyond 2 years remains limited.
Clinical trials of Foundayo , the first oral GLP-1 receptor agonist for type 2 diabetes, enrolled over 9,500 participants across Phase 2 and 3 studies, with gastrointestinal events affecting 60-80% of patients but leading to discontinuation in only 8-12%.
Foundayo mimics the body's natural GLP-1 hormone to regulate blood sugar by stimulating insulin release and slowing gastric emptying, offering patients an oral alternative to injectable medications many avoid due to needle phobia or injection site reactions.
Gastrointestinal side effects peak during the first 4-8 weeks with nausea, vomiting, and diarrhea, though most symptoms were mild to moderate and improved as the body adapted; gradual dose escalation helps minimize effects while patients build tolerance.
Most treatment discontinuations occur within the first 12 weeks, after which patients experience stable side effect profiles; hypoglycemia rates remained low at under 5% when Foundayo was used without insulin or sulfonylureas.
The SCORE cardiovascular outcomes trial will follow 9,650 patients for a minimum of 3 years with results expected by 2026, as Phase 3 data extends only to 68 weeks and true long-term safety beyond 2 years requires ongoing cardiovascular studies and post-market surveillance.