Severe HypertriglyceridemiaPhase 2INDIGO-1NCT02944383
A 12-Week Study to Assess the Efficacy Safety and Tolerability of Gemcabene in Subjects With Severe Hypertriglyceridemia
A Phase 2 study testing Gemcabene in people with Severe Hypertriglyceridemia and Mixed Dyslipidaemia, run by NeuroBo Pharmaceuticals Inc. at 49 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypertriglyceridemia, Mixed Dyslipidaemia
- What is being tested?
- Gemcabene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Dec 2016to 9 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following criteria will be eligible to participate in the study:
- Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedure;
- Male or female (neither pregnant or lactating) ≥18 years of age at time of consent;
- Women of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine dipstick on Study Day 1 prior to dosing in order to qualify for the study. Women who are surgically sterile or are clinically confirmed to be post-menopausal (i.e., documented amenorrhea for ≥ 1 year in the absence of other biological or physiological causes) are not considered to be of child-bearing potential;
- Women of child-bearing potential must agree to use acceptable methods of contraception throughout the duration of the study and for 30 days after the last dose of study drug. For this study, double-barrier contraception is required.
- Currently on a self-reported, stable, low-fat, low-cholesterol diet in combination with stable statins with or without ezetimibe (10 mg QD) for at least 12 weeks prior to the Screening Visit;
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- Mean fasting TG value ≥ 500 mg/dL to < 1500 mg/dL (with the higher value no more than 50% greater than the lower value) from the S1 and S2 Visits (or alternatively S2 and S3);
- Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;
- Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m²; and
- Subjects with Type 2 diabetes who take anti-diabetes pharmacologic therapy must be on a stable a regimen for at least 3 months, with no planned changes in medications for the study duration.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Known and previously documented homozygous genetic deficiencies (LPL, ApoC-II, ApoC-III, ApoA-V, GPIHBP1, or LMF1);
- History of pancreatitis within the last 6 months prior to screening (Visit S1);
- History of bariatric surgery; symptomatic gallstone disease, unless treated with cholecystectomy;
- Abnormal liver function test at the Pre-Screening Visit or any of the Screening Visits (aspartate aminotransferase or alanine aminotransferase > 2 × the upper limit of normal [ULN], total bilirubin > 1.5 × ULN, or alkaline phosphatase > 2 × ULN based on appropriate age and gender normal values). Subjects with bilirubin > 1.5 × ULN and history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
- Active liver disease (e.g., cirrhosis, alcoholic liver disease, hepatitis B [HBV], hepatitis C [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of human immunodeficiency virus (HIV), or acquired immune deficiency virus;
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- Moderate to severe renal insufficiency defined as an estimated GFR < 60 mL/min/1.73 m2 (calculated using The Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or at any of the Screening Visits;
- Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria), confirmed by reflexive urine protein:creatinine ratio testing;
- Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or > 1.5 × ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to the Screening Visit;
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus HbA1c value ≥8.5% based on results from the Pre-Screening Visit or the Screening Visit), or any diabetic subject taking a thiazolidinedione (e.g., pioglitazone, rosiglitazone);
- New York Heart Association Class III or IV heart failure (see Appendix C);
- Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit (S1). Subjects with adequately treated stable angina, per Investigator assessment, may be included;
- Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Study Day 1 prior to dosing ECG (QTcF > 450 msec for men and >470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;
- Uncontrolled hypertension, defined as sitting systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, and confirmed by repeat measurement;
- Currently receiving cancer treatment(s) or, in the Investigator's opinion, at risk of relapse for recent cancer;
- Inadequate washout of a PCSK9 inhibitor (8 weeks prior to the Screening Visit S1), a fibrate lipid lowering agent (6 weeks prior to the Screening Visit S1), niacin > 200 mg/day, OMG-3, bile acid sequestrants or other lipid lowering therapies (4 weeks prior to the Screening Visit S1);
- Use of any excluded medications or supplements within 3 months prior to S1 (e.g., potent cytochrome P450 [CYP] 3A4 inhibitors, see Appendix D);
- Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid regulating agent;
- History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subject alcohol restrictions (see Section 5.6.3);
- Previously treated with gemcabene (i.e., CI-1027); participation in another clinical study of an investigational agent or device concurrently or within 1 month prior to the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit; or
- Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States48 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48105
University of Maryland Medical Center
Baltimore, Maryland, 21201
Eastern Carolina Medical Clinic
Benson, North Carolina, 27504
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211
Excel Medical Research
Boca Raton, Florida, 33434
Meridien Research
Bradenton, Florida, 34201
Hope Clinical Research
Canoga Park, California, 91303
Optimed Research
Columbus, Ohio, 43235
Clinical Trials Management, LLC
Covington, Louisiana, 70433
PriMed Clinical Research
Dayton, Ohio, 45419
Evanston Premier Clinical Research
Evanston, Illinois, 60201
Physicians East, NA
Farmville, North Carolina, 27828
Appalachian Research Associates
Fort Payne, Alabama, 35967
SC Clinical Research
Garden Grove, California, 92844
Physicians East, NA
Greenville, North Carolina, 27834
Direct Helpers Research Center
Hialeah, Florida, 33012
Indago Research and Health Center
Hialeah, Florida, 33012
Airline Complete Healthcare
Houston, Texas, 77091
National Research Institute
Huntington Park, California, 90255
Midwest Institute for Clinical Research, Inc.
Indianapolis, Indiana, 46260
Elite Clinical Research
Jackson, Mississippi, 39202
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Richard Lochamy, M.D.
Junction City, Kansas, 66441
University of Kansas Medical Center
Kansas City, Kansas, 66160
Clinical Investigation Specialists
Kenosha, Wisconsin, 53142
Sante Clinical Research
Kerrville, Texas, 78028
FMC Science
Lampasas, Texas, 76550
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319
BTC of Lincoln
Lincoln, Rhode Island, 02865
National Research Institute
Los Angeles, California, 90057
L-MARC Research Center
Louisville, Kentucky, 40213
Clinical Trials Management, LLC
Metairie, Louisiana, 70006
San Marcus Research Clinic, Inc.
Miami, Florida, 33015
Millenium Clinical Research, Inc.
Miami, Florida, 33125
Medcare Research
Miami, Florida, 33165
AR Developoment Solutions
Miami Lakes, Florida, 33014
Cary Medical Clinic
Morrisville, North Carolina, 27560
Clinical Investigations of Texas
Plano, Texas, 75075
Carolinas Research Partners, LLC
Rock Hill, South Carolina, 29732
Sun Research Institute
San Antonio, Texas, 78215
Paradigm Clinical Research
San Diego, California, 92117
CHEAR Center, LLC
The Bronx, New York, 10455
Advantage Clinical Trials
The Bronx, New York, 10468
Del Sol Research Mangagement, LLC
Tucson, Arizona, 85710
Soma Medical Research
West Palm Beach, Florida, 33406
Paradigm Research
Wheat Ridge, Colorado, 80033
About this study
Official title: 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)
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)
- Conditions
- Severe Hypertriglyceridemia, Mixed Dyslipidaemia
- Being tested
- Gemcabene, Placebo
- Keywords
- Hypertriglycerides
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcabeneDrug
Gemcabene tablets administered orally once daily, for 12 weeks.
PlaceboDrug
Placebo tablets administered orally once daily, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene 300 mg | Experimental | Participants received 300 mg Gemcabene orally, once daily for 12 weeks. Receives: Drug: Gemcabene |
| Gemcabene 600 mg | Experimental | Participants received 600 mg Gemcabene orally, once daily for 12 weeks. Receives: Drug: Gemcabene |
| Placebo | Placebo comparator | Participants received matching placebo orally, once daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF).
Measured: Baseline, EOS (average of week 10 and 12)
Secondary outcomes (49)
Percent Change From Baseline in Fasting Serum TG
Measured: Baseline, Weeks 2, 6, 10 and 12
Change From Baseline in Fasting Serum TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in TC
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in TC
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Non-HDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Non-HDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in VLDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in VLDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in HDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in HDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein B
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein B
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein A-I
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein A-I
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein A-II
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein A-II
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein C-II
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein C-II
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein C-III
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein C-III
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein E
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein E
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in LDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in LDL-C
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in LDL-TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in LDL-TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in VLDL-TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in VLDL-TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in HDL-TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in HDL-TG
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Lipoprotein Size
Percent change from baseline in Particle size for VLDL, HDL and LDL were reported.
Measured: Baseline, Week 12
Change From Baseline in Lipoprotein Size
Change from baseline in Particle size for VLDL, HDL and LDL were reported.
Measured: Baseline, Week 12
Percent Change From Baseline in Lipoprotein Particle Number
Percent change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.
Measured: Baseline, Week 12
Change From Baseline in Lipoprotein Particle Number
Change from baseline in particle number for VLDL \& chylomicron, LDL and IDL were reported.
Measured: Baseline, Week 12
Percent Change From Baseline in HDL Particle Number
Measured: Baseline, Week 12
Change From Baseline in HDL Particle Number
Measured: Baseline, Week 12
Percent Change From Baseline in High-sensitivity C-reactive Protein
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in High-sensitivity C-reactive Protein
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Fibrinogen
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Fibrinogen
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Serum Amyloid A
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Serum Amyloid A
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Adiponectin
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Week 12 and EOS (average of week 10 and 12)
Change From Baseline in Adiponectin
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Week 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Angiopoietin 4
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Week 12 and EOS (average of week 10 and 12)
Change From Baseline in Angiopoietin 4
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Week 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Interleukin-6
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Interleukin-6
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percentage of Participants Achieving a TG Value < 500 mg/dL (5.65 mmol/L)
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using LOCF.
Measured: Weeks 10, 12 and EOS (average of week 10 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion11 Jan 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Golden, MD, Study director, NeuroBo Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944383
- Sponsor's protocol ID
- GEM-401
- Acronym
- INDIGO-1
- Status last verified
- Jun 2020
- First submitted
- 24 Oct 2016
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02944383
- Acronym / sponsor ID
- INDIGO-1 / GEM-401
- Conditions
- Severe Hypertriglyceridemia, Mixed Dyslipidaemia
- Keywords
- Hypertriglycerides
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Posted 25 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gemcabene 300 mg | Experimental | Drug: GemcabeneParticipants received 300 mg Gemcabene orally, once daily for 12 weeks. |
| Gemcabene 600 mg | Experimental | Drug: GemcabeneParticipants received 600 mg Gemcabene orally, once daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo orally, once daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who meet all of the following criteria will be eligible to participate in the study:
- Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedure;
- Male or female (neither pregnant or lactating) ≥18 years of age at time of consent;
- Currently on a self-reported, stable, low-fat, low-cholesterol diet in combination with stable statins with or without ezetimibe (10 mg QD) for at least 12 weeks prior to the Screening Visit;
- Mean fasting TG value ≥ 500 mg/dL to < 1500 mg/dL (with the higher value no more than 50% greater than the lower value) from the S1 and S2 Visits (or alternatively S2 and S3);
Key exclusion criteria (21 listed)
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Known and previously documented homozygous genetic deficiencies (LPL, ApoC-II, ApoC-III, ApoA-V, GPIHBP1, or LMF1);
- History of pancreatitis within the last 6 months prior to screening (Visit S1);
- History of bariatric surgery; symptomatic gallstone disease, unless treated with cholecystectomy;
- Abnormal liver function test at the Pre-Screening Visit or any of the Screening Visits (aspartate aminotransferase or alanine aminotransferase > 2 × the upper limit of normal [ULN], total bilirubin > 1.5 × ULN, or alkaline phosphatase > 2 × ULN based on appropriate age and gender normal values). Subjects with bilirubin > 1.5 × ULN and history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcabeneGemcabene tablets administered orally once daily, for 12 weeks. | Drug | Gemcabene 300 mg, Gemcabene 600 mg |
| PlaceboPlacebo tablets administered orally once daily, for 12 weeks. | Drug | Placebo |
Primary outcome
Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG)
Time frame: Baseline, EOS (average of week 10 and 12)
EOS was defined as the average of the week 10 and week 12 values. If either the week 10 or week 12 value was missing, then the single value (week 10 or week 12) was used. Completely missing values (both week 10 and week 12) were imputed using last observation carried forward (LOCF).
49 secondary outcomes
Percent Change From Baseline in Fasting Serum TG
Time frame: Baseline, Weeks 2, 6, 10 and 12
Change From Baseline in Fasting Serum TG
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in TC
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in TC
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Non-HDL-C
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Non-HDL-C
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in VLDL-C
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in VLDL-C
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in HDL-C
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in HDL-C
Time frame: Baseline, Weeks 2, 6, 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein B
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein B
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein A-I
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein A-I
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein A-II
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein A-II
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein C-II
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein C-II
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein C-III
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein C-III
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Apolipoprotein E
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Apolipoprotein E
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in LDL-C
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in LDL-C
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in LDL-TG
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in LDL-TG
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in VLDL-TG
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in VLDL-TG
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in HDL-TG
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in HDL-TG
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Lipoprotein Size
Time frame: Baseline, Week 12
Change From Baseline in Lipoprotein Size
Time frame: Baseline, Week 12
Percent Change From Baseline in Lipoprotein Particle Number
Time frame: Baseline, Week 12
Change From Baseline in Lipoprotein Particle Number
Time frame: Baseline, Week 12
Percent Change From Baseline in HDL Particle Number
Time frame: Baseline, Week 12
Change From Baseline in HDL Particle Number
Time frame: Baseline, Week 12
Percent Change From Baseline in High-sensitivity C-reactive Protein
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in High-sensitivity C-reactive Protein
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Percent Change From Baseline in Fibrinogen
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Change From Baseline in Fibrinogen
Time frame: Baseline, Weeks 10, 12 and EOS (average of week 10 and 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Golden, MD study director
NeuroBo Pharmaceuticals Inc.
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcabene in people with Severe Hypertriglyceridemia and Mixed Dyslipidaemia, run by NeuroBo Pharmaceuticals Inc. at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline to End of Study (EOS) in Fasting Serum Triglycerides (TG) (time frame: Baseline, EOS (average of week 10 and 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.