Trials / Terminated
TerminatedNCT05211284
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With Human Immunodeficiency Virus (HIV) in the US
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Zydus Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living with Human Immunodeficiency Virus (HIV) in the US The four participants enrolled on version 3.0 protocol were terminated as the primary endpoint was revised from biopsy to an imaging-based approach in the subsequent protocol version 4.0. These changes were done due to recruiting challenges pertaining to biopsy. However, no participants were enrolled in the revised protocol (version 4.0) as, by then the decision to terminate the study was taken by the Sponsor considering the modifications in the internal R\&D focus and a revised commercialization strategy. The version 3.0 protocol is dated 02/Jun/2022.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Saroglitazar Magnesium 4 mg | Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks). |
| DRUG | Placebo | Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). |
Timeline
- Start date
- 2022-12-08
- Primary completion
- 2023-10-02
- Completion
- 2023-10-02
- First posted
- 2022-01-27
- Last updated
- 2025-09-02
- Results posted
- 2025-07-16
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05211284. Inclusion in this directory is not an endorsement.