Trials / Active Not Recruiting
Active Not RecruitingNCT05665751
A Study Evaluating Daily Oral Doses of TLC-3595 in Participants With Insulin Resistance
A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-3595 in Subjects With Insulin Resistance
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- OrsoBio, Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 2a study is designed to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of TLC-3595 in subjects with insulin resistance.
Detailed description
This is a multicenter, double-blind, randomized study. Participants will be randomized to one of three treatment arms, to receive one of the two doses of TLC-3595 (or matching placebo).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TLC-3595 Dose 1 | Tablets administered orally |
| DRUG | TLC-3595 Dose 2 | Tablets administered orally |
| DRUG | Placebo | Tablets administered orally |
Timeline
- Start date
- 2023-03-08
- Primary completion
- 2024-09-01
- Completion
- 2024-12-01
- First posted
- 2022-12-27
- Last updated
- 2024-08-20
Locations
4 sites across 1 country: New Zealand
Source: ClinicalTrials.gov record NCT05665751. Inclusion in this directory is not an endorsement.