At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Gemcabene +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Gemcabene and Placebo for Severe Hypertriglyceridemia and Mixed Dyslipidaemia. Completed, enrolled 91 participants across 49 sites in 2 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hypertriglyceridemia, Mixed Dyslipidaemia
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartDec 2016
Primary CompletionJan 2018
Study CompletionMay 2018
TodayJul 2026
First PostedOct 25, 2016
Enrollment StartDec 1, 2016
Primary CompletionJan 11, 2018
Study CompletionMay 9, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.7 years ago
Interventions
Gemcabenedrug
Gemcabene tablets administered orally once daily, for 12 weeks.
Placebodrug
Placebo tablets administered orally once daily, for 12 weeks.