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TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients (TRIAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Type 2 Diabetes Drug: DS102 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: DS102 2000mg
Participants in this group will receive 1000mg DS102 capsules twice daily.
Drug: DS102
DS102 capsules

Experimental: DS102 4000mg
Participants in this group will receive 2000mg DS102 capsules twice daily.
Drug: DS102
DS102 capsules

Placebo Comparator: Placebo
Participants in this group will receive placebo capsules twice daily.
Drug: Placebo
Placebo capsules




Primary Outcome Measures :
  1. Percent change in triglycerides from baseline to week 16 [ Time Frame: 16 weeks ]
    Percent change in triglycerides from baseline to week 16

  2. Change in HbA1c from baseline to week 26 [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline to week 26


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365400


Contacts
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Contact: Karen Doyle, MSc +3532946380 karen.doyle@afimmune.com
Contact: Moayed Hamza, MD +3532946380 m.hamza@afimmune.com

Locations
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Sponsors and Collaborators
Afimmune
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Responsible Party: Afimmune
ClinicalTrials.gov Identifier: NCT04365400    
Other Study ID Numbers: DS102A-07-CV1
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Hypertriglyceridemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders