drugset / Trial / NCT06901648
A Study of HS-20094 in Patients With T2DM
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.
Timeline
- Start
- 2024-02-06
- Primary completion
- 2025-03-07
- Completion
- 2025-04-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |
| Subject | Olatorepatide | Protein / enzyme biologic | 5 mg | Subcutaneous |
| Subject | Olatorepatide | Protein / enzyme biologic | 10 mg | Subcutaneous |
| Subject | Olatorepatide | Protein / enzyme biologic | 15 mg | Subcutaneous |