At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
CIVI 007drug
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 Placebo-controlled, Randomized, Phase 2a, Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CIVI 007 in Patients on a Background of Stable Statin Therapy
In Brief
A Phase 2 clinical trial evaluating CIVI 007 for Hypercholesterolemia. Completed, enrolled 49 participants across 7 sites.
Detailed Summary
Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedNov 2019
Primary CompletionJun 2020
Study CompletionNov 2020
TodayJul 2026
First PostedNov 15, 2019
Enrollment StartNov 11, 2019
Primary CompletionJun 18, 2020
Study CompletionNov 17, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.6 years ago
Interventions
CIVI 007drug
hypercholesterolemia agent