drugset / Trial / NCT02944383
A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
RandomizedParallel-groupTriple-blindTreatment
Summary
A 12-Week, Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects with Severe Hypertriglyceridemia (INDIGO-1)
Timeline
- Start
- 2016-12
- Primary completion
- 2018-01-11
- Completion
- 2018-05-09
Outcome
Met primary endpoint
registry analysis (superiority test); Gemcabene 600 mg vs Placebo; p = 0.0063; Median Difference (Net) -19.02 (95% CI -33.07 to -4.25); Ranked ANCOVA NCT02944383 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcabene | Small molecule | 300 mg | Oral |
| Subject | Gemcabene | Small molecule | 600 mg | Oral |