Trials / Completed
CompletedNCT06256523
A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Gan and Lee Pharmaceuticals, USA · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GZR18 | 0.5mg-13mg |
| OTHER | Placebo | administered the same volume as GZR18 |
Timeline
- Start date
- 2022-06-29
- Primary completion
- 2023-09-28
- Completion
- 2023-09-28
- First posted
- 2024-02-13
- Last updated
- 2024-02-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06256523. Inclusion in this directory is not an endorsement.