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Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes
Safety and body processing of increasing doses of the new oral GLP-1 drug, semaglutide, in healthy people and those with type 2 diabetes
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Abstract
Oral semaglutide was safe and well-tolerated in trials involving 135 healthy males and 23 males with type 2 diabetes.
- The majority of adverse events were mild, with gastrointestinal disorders being the most common.
- In the single-dose trial, semaglutide exposure was highest when co-formulated with 300 mg SNAC.
- In the multiple-dose trial, semaglutide exposure increased approximately twofold with 40 mg compared to 20 mg.
- Semaglutide exposure was similar between healthy males and males with type 2 diabetes.
- The half-life of semaglutide was approximately 1 week across all groups.
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