A Study of PATAS Trifluoroacetate Using Single Ascending Doses in Healthy Volunteers and Multiple Ascending Doses in Subjects With Type 2 Diabetes

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-09-30

Summary

The primary objective of Part 1 of this study is to evaluate safety and tolerability of single subcutaneous (SC) doses of PATAS in healthy subjects. The secondary objective of Part 1 of this study is to determine the pharmacokinetics (PK) of single SC doses of PATAS in healthy subjects. The primary objectives of Part 2 of this study are to evaluate the safety and tolerability of 4 weekly SC doses of PATAS in subjects with T2D; and to determine the PK and pharmacodynamics (PD) of 4 weekly SC doses of PATAS in subjects with T2D. The secondary objectives of Part 2 of this study are to evaluate the potential effect of multiple SC doses of PATAS on markers of glycemic control, as measured by glucose levels, insulin levels, and other metabolomic biomarkers; and to characterize the adverse event (AE) profiles of the various dose levels of PATAS.

• Phase: PHASE1

Details

• Lead Sponsor: AdipoPharma LLC