drugset / Trial / NCT06700538
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).
Timeline
- Start
- 2024-12-04
- Primary completion
- 2027-09-17
- Completion
- 2028-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARO-INHBE | Unknown | — | Subcutaneous |
| Background | Tirzepatide | Peptide | 2.5 mg | Subcutaneous |
| Background | Tirzepatide | Peptide | 5 mg | Subcutaneous |
| Background | Tirzepatide | Peptide | 15 mg | Subcutaneous |