TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients

• Status: Recruiting
• Trial end date: 2022-09-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Afimmune

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- 10% (53-86mmol/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.