Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02585869

Enrollment

161

Registered

2015-10-23

Start date

1999-12-31

Completion date

2001-06-30

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Hypertriglyceridemia

Keywords

Lipid Regulator, TG

Brief summary

The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C

Interventions

DRUGGemcabene 150 mg

Blinded capsules and tablets, 150 mg, once daily, 84 days

DRUGGemcabene 300 mg

Blinded capsules and tablets, 300 mg, once daily, 84 days

DRUGGemcabene 600 mg

Blinded capsules and tablets, 600 mg, once daily, 84 days

DRUGGemcabene 900 mg

Blinded capsules and tablets, 900 mg, once daily, 84 days

DRUGPlacebo

Blinded capsule and tablets, once daily, 84 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Men or naturally postmenopausal or surgically menopausal women * 18 to 80 years of age * Baseline HDL-C \<35 mg/dL (0.9 mmol/L)

Exclusion criteria

* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN) * Body Mass Index (BMI) \>35 kg/m2 * Uncontrolled Hypertension \>95 mm Hg * Uncontrolled diabetes mellitus (HbA1c \>10%) * Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN); * Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN) * Uncontrolled hypothyroidism (TSH \>1.5 × ULN) * Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months

Design outcomes

Primary

Measure	Time frame
HDL-C - percent change from baseline	84 days

Secondary

Measure	Time frame	Description
Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline	84 days	—
Adverse Events	84 days	—
Clinical Laboratory - hematology, chemistry, urinalysis	84 days	Clinical Laboratory Abnormalities

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026