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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
Sponsor:
Information provided by (Responsible Party):
Afimmune

Tracking Information
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
 (submitted: April 24, 2020)
  • Percent change in triglycerides from baseline to week 16 [ Time Frame: 16 weeks ]
    Percent change in triglycerides from baseline to week 16
  • Change in HbA1c from baseline to week 26 [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline to week 26
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • Percent change in triglycerides from baseline to weeks 4, 8, 12, 20 and 26 [ Time Frame: 26 weeks ]
    Percent change in triglycerides from baseline to weeks 4, 8, 12, 20 and 26
  • Change in HbA1c from baseline to weeks 4, 8, 12, 16 and 20 [ Time Frame: 20 weeks ]
    Change in HbA1c from baseline to weeks 4, 8, 12, 16 and 20
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
Condition  ICMJE
  • Hypertriglyceridemia
  • Type 2 Diabetes
Intervention  ICMJE
  • Drug: DS102
    DS102 capsules
  • Drug: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: DS102 2000mg
    Participants in this group will receive 1000mg DS102 capsules twice daily.
    Intervention: Drug: DS102
  • Experimental: DS102 4000mg
    Participants in this group will receive 2000mg DS102 capsules twice daily.
    Intervention: Drug: DS102
  • Placebo Comparator: Placebo
    Participants in this group will receive placebo capsules twice daily.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2020)
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;

  1. cirrhosis,
  2. active hepatitis,
  3. biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and AST or ALT >3 times the upper limit of normal.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Doyle, MSc +3532946380 karen.doyle@afimmune.com
Contact: Moayed Hamza, MD +3532946380 m.hamza@afimmune.com
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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