Safety and Pharmacokinetic Evaluation of
Oral Tirzepatide Capsules with DehydraTECH™ Technology in Healthy Volunteers

This pilot clinical study evaluated the safety, pharmacokinetics, pharmacodynamics, and tolerability of a novel oral tirzepatide formulation utilizing DehydraTECH™ drug delivery technology compared to subcutaneous tirzepatide (Zepbound®) in healthy adult volunteers. The study aimed to determine whether the DehydraTECH-tirzepatide capsules could achieve meaningful glucose control and insulin response with improved tolerability and enhanced oral bioavailability.
        The oral formulation achieved comparable glucose-lowering effects to injectable tirzepatide despite a significantly lower oral-to-injectable conversion ratio (56-fold vs. 98–196-fold reported for oral semaglutide), suggesting improved delivery efficiency. Participants receiving the oral capsules experienced 47% fewer adverse events, including markedly fewer gastrointestinal symptoms, compared to the injection group. Insulin peaks occurred earlier and were higher with the oral formulation, though with greater interindividual variability, and glucose rebound after 120 hours highlighted the need for longer-term dosing studies.

        These findings support the potential of DehydraTECH-tirzepatide as a viable oral alternative to injectable GLP-1 therapy, with advantages in adherence, convenience, and tolerability. Further research is warranted to optimize dosing strategies and evaluate long-term metabolic outcomes.

Date  May 2025

 

Clinical Trial  A sponsor initiated, post-marketing clinical trial