drugset / Trial / NCT05822544

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

NCT05822544

Phase 1 Recruiting 564 enrolled OrsoBio, Inc
RandomizedSequentialDouble-blindTreatment

Summary

The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.

Timeline

Start
2023-04-22
Primary completion
2026-02
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule Oral
Subject Omeprazole Other / unclassified Oral
Subject Rifampin Small molecule Oral
Subject TLC-6740 Unknown Oral
Subject Voriconazole Small molecule Oral
Background Tirzepatide Peptide Subcutaneous