TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients (TRIAGE)
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ClinicalTrials.gov Identifier: NCT04365400 |
Recruitment Status :
Recruiting
First Posted : April 28, 2020
Last Update Posted : November 16, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | April 24, 2020 | ||||||||
First Posted Date ICMJE | April 28, 2020 | ||||||||
Last Update Posted Date | November 16, 2020 | ||||||||
Actual Study Start Date ICMJE | September 23, 2020 | ||||||||
Estimated Primary Completion Date | October 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients | ||||||||
Official Title ICMJE | A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes | ||||||||
Brief Summary | To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
240 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 1, 2021 | ||||||||
Estimated Primary Completion Date | October 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first screening visit. Patients with a HbA1C (glycosylated haemoglobin) between 7.5 - 9.5% (59.5-80.3 mmol/mol) Patients with a fasting triglyceride level ≥200 mg/dL and <750mg/dL at both screening visits. Exclusion Criteria: Patients who have a history of intolerance or hypersensitivity to any substance in epeleuton capsules, placebo capsules or statins. Patients with active severe liver disease defined as any of the following;
Patients with a history of malignancies within the past 5 years other than curatively treated non-melanoma skin cancer (basal cell or squamous cell carcinomas). Patients who have been treated with any investigational product within 60 days prior to visit 1, or 5 half-lives (whichever is longer). Patients cannot participate in any other investigational medication or medical device trial while participating in this study. Patients who have been treated with any medication for diabetes or obesity in the four weeks before the baseline visit, except for metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors and short-term insulin treatment for acute illness for a total of below or equal to 14 days. Patients who have a family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomas. Patients who have a history of acute or chronic pancreatitis. Patients who have a history of major surgical procedures involving the stomach potentially affecting absorption of investigational medicinal product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) Patients who have planned major surgical procedures, coronary intervention (such as stent placement or heart bypass), carotid or peripheral revascularisation. Patients who have a history of myocardial infarction, stroke, coronary revascularisation or hospitalisation for unstable angina in the 3 months prior to screening. Patients who have a history of diabetic ketoacidosis. Patients with significant systemic or major illnesses that, in the opinion of the Investigator, would preclude or interfere with treatment with Epeleuton, adequate follow up and/or compliance with the protocol.Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in Inclusion Criterion 9) during the trial. Patients who have previously entered into the study. Patients, in the opinion of the Investigator, not suitable to participate in the study. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany, Israel, Latvia, Switzerland, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04365400 | ||||||||
Other Study ID Numbers ICMJE | DS102A-07-CV1 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Afimmune | ||||||||
Study Sponsor ICMJE | Afimmune | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Afimmune | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |