Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
Condition: Hypertriglyceridemia; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypertriglyceridemia
Intervention: DS102; Placebo
Intervention description: DS102 Epeleuton capsules; Placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first
             screening visit.

          2. Patients with a HbA1C (glycosylated haemoglobin) between 7.0 - 10.0% (53-86 mmol/mol)
             (both inclusive)

          3. Patients with a fasting triglyceride level ≥200 mg/dL (2.26 mmol/L) and <750mg/dL
             (8.46 mmol/L) at both screening visits.

             Note: If the triglyceride level is outside the required range at the second screening
             visit, an additional measurement can be obtained 1 week later, to confirm eligibility.

             Note: If a large difference in triglyceride level (>15%) is observed between screening
             1 and screening 2, an additional measurement may be requested or patient may be deemed
             not eligible.

          4. Patients who have been educated regarding diet and exercise at or before visit 1
             (screening 1) and are willing to maintain and not alter a stable diet and activity
             routine throughout the study.

          5. Patients who have been on a stable statin therapy at doses that are likely to achieve
             optimal LDL cholesterol and who are willing to continue this treatment throughout the
             study.

             Note: Stable statin therapy may consist of a statin with or without ezetimibe.

          6. Patients with an LDL cholesterol level <130mg/dL (3.34 mmol/L) at both screening
             visits.

          7. Patients who have a body mass index (BMI) ≥ 25kg/m2 and <50kg/m2.

          8. Patients who have been on a stable daily dose of metformin (at least 1500mg or maximum
             tolerated dose for metformin monotherapy as documented in the subject medical record)
             and/or a sulfonylurea and/or a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a
             sodium-glucose transport protein 2 inhibitor (SGLT2i) and/or a GLP1-RA and/or basal
             insulin for at least 90 days prior to the day of first screening visit.

             Note: Dose of GLP1-RA must be stable for 6 months prior to baseline with no weight
             change >2kg for 3 months prior to baseline.

             Note: Dose of basal insulin must be stable for 4 months prior to baseline. All types
             of basal insulin are permitted, including insulin glargine, insulin degludec, insulin
             detemir, NPH insulin and pre-mixed insulin.

          9. Female patients and male patients with female partners of childbearing potential must
             use highly effective contraceptive methods or have a sterilised partner for the
             duration of the study. Highly effective contraceptive methods are defined as methods
             that can achieve a failure rate of less than 1% per year when used consistently and
             correctly. Such methods include hormonal contraception, intrauterine device or sexual
             abstinence.

             Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following
             menarche and until becoming post-menopausal unless permanently sterile. Permanent
             sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral
             oophorectomy.

             Note: Hormonal contraceptives must be on a stable dose for at least one month before
             baseline.

             Note: Sexual abstinence is considered a highly effective method only if defined as
             refraining from heterosexual intercourse during the entire period of risk associated
             with the study treatments. The reliability of sexual abstinence needs to be evaluated
             in relation to the duration of the clinical trial and the preferred and usual
             lifestyle of the patient.

         10. Patients whose pre-study or screening clinical laboratory findings do not interfere
             with their participation in the study, in the opinion of the Investigator, and do not
             violate any inclusion or exclusion criteria

         11. Male or female patients aged 18 years and older on the day of signing the informed
             consent form (ICF).

         12. Patients who are able to communicate well with the Investigator, to understand and
             comply with the requirements of the study, and understand and sign the written
             informed consent prior to initiation of any study specific activities or procedures.