TRIgyceride And Glucose Control With Epeleuton in Metabolic Syndrome Patients

  • STATUS
    Recruiting
  • End date
    Dec 1, 2021
  • participants needed
    240
  • sponsor
    Afimmune
Updated on 26 January 2021

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

Details
Condition NIDDM, Diabetes Mellitus, Hypertriglyceridemia, Hyperlipidemia, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, High Cholesterol (Hyperlipidemia), Diabetes (Pediatric), Elevated Triglycerides (Hypertriglyceridemia), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Placebo, DS102
Clinical Study IdentifierNCT04365400
SponsorAfimmune
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
cirrhosis
active hepatitis
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
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