Insulin SensitivityPhase 2NCT02586168
The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects
A Phase 2 study testing Gemcabene 900 mg in people with Insulin Sensitivity, run by NeuroBo Pharmaceuticals Inc..
Trial summary
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Gemcabene 900 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Oct 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
- Males; and females of non-reproductive potential
- Obesity
- Non-diabetic
Who cannot join
- Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable.
- Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
- Use of any anti-diabetic medications
- Use of any steroid medications
- Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
- If female, pregnant, lactating or of childbearing potential; and
- History of significant reaction to any fibrate lipid-lowering agent
About this study
Official title: The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.
- Conditions
- Insulin Sensitivity
- Being tested
- Gemcabene 900 mg, Placebo
- Keywords
- Insulin Resistance, Lipid Regulator
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcabene 900 mgDrug
Gemcabene 900 mg once daily (QD)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg Receives: Drug: Gemcabene 900 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: 4 weeks
Secondary outcomes (3)
Adverse Events
Measured: 4 weeks
ECG
Clinically Significant Changes
Measured: 4 weeks
Clinical Laboratory - hematology, chemistry
Clinical Laboratory Abnormalities
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startJul 2001
- Primary completionOct 2001
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586168
- Sponsor's protocol ID
- 1027-014
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2015
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects
- ClinicalTrials.gov ID
- NCT02586168
- Acronym / sponsor ID
- 1027-014
- Conditions
- Insulin Sensitivity
- Keywords
- Insulin Resistance, Lipid Regulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcabene 900 mg | Experimental | Drug: Gemcabene 900 mgGemcabene 900 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
- Males; and females of non-reproductive potential
- Obesity
- Non-diabetic
Key exclusion criteria (7 listed)
- Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable.
- Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
- Use of any anti-diabetic medications
- Use of any steroid medications
- Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
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 |
|---|---|---|
| Gemcabene 900 mgGemcabene 900 mg once daily (QD) | Drug | Gemcabene 900 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Insulin sensitivity
Time frame: 4 weeks
3 secondary outcomes
Adverse Events
Time frame: 4 weeks
ECG
Time frame: 4 weeks
Clinical Laboratory - hematology, chemistry
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcabene 900 mg in people with Insulin Sensitivity, run by NeuroBo Pharmaceuticals Inc..
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 4 inclusion and 7 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity (time frame: 4 weeks). 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 9 Apr 2020.