A study to investigate the mechanism of action and safety of Epeleuton capsules in the treatment of patients with type 2 diabetes and diabetic complications

A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study to Assess the Mechanism of Action and Safety of Orally Administered Epeleuton in Patients with Type 2 Diabetes and Diabetic Complications - Mechanism of Epeleuton in Patients with Type 2 Diabetes and Diabetic Complications (METABOLIC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002911-23-DE

Enrollment

Registered

2020-08-07

Start date

2020-10-12

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes and diabetic complications MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: HLGT Classification code 10012653 Term: Diabetic complications System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Name: DS102 Capsule Product Code: DS102 Pharmaceutical Form: Capsule, hard INN or Proposed INN: epeleuton CAS Number: 1667760-39-5 Current Sponsor code: DS102 Other descriptive name: 15(S)-HYD

Eligibility

Sex/Gender

All

Inclusion 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% (53-85.8 mmol/mol) (both inclusive) 3. Patients with a fasting triglyceride level =120 mg/dL and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Patients who have a history of intolerance or hypersensitivity to any substance in Epeleuton capsules, placebo capsules, statins, metformin, sulfonylureas, DPP-4 inhibitors or SGLT2i. 2. Patients with uncontrolled hypertension defined as a systolic blood pressure =160 mmHg or a diastolic blood pressure =100mmHg. 3. Patients who have a BMI 2kg from the first screening visit to the baseline visit. 5. Patients who have type 1 diabetes mellitus. 6. Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal. 7. Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal. 8. Patients with stage 4 or stage 5 chronic kidney disease (CKD) defined as an estimated glomerular filtration rate 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1) 21. Patients who are classified as being in New York Heart Association (NYHA) Class IV. 22. Patients who have a history of diabetic ketoacidosis. 2

Design outcomes

Primary

Measure	Time frame
Main Objective: Pharmacodynamic Objective: To assess the molecular mechanism of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with type 2 diabetes and diabetic complications;Secondary Objective: Safety Objective: To assess the safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with type 2 diabetes and diabetic complications. Efficacy Objective: To assess the efficacy of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with type 2 diabetes and diabetic complications.;Primary end point(s): Outcome Measures: 1. Change in the mononuclear methylation pattern from baseline to week 16. 2. Change in miRNAs from baseline to week 16. 3. Change in HbA1c from baseline to weeks 4, 8, 12 and 16. 4. Change in fasting plasma glucose from baseline to weeks 4, 8, 12 and 16. 5. Proportion of patients achieving a HbA1c below 6.5% at weeks 4, 8, 12 and 16. 6. Proportion of patients achieving a HbA1c below 7.0% at weeks 4, 8, 12 and 16. 7. Change in urinary albumin/creatinine ratio (UACR) from baseline to week 16. 8. Change in the signs and symptoms of diabetic peripheral neuropathy from baseline to week 16. 9. Change in high-sensitivity C-reactive protein (hsCRP) from baseline to week 16. 10. Change in exploratory serum and plasma biomarkers from baseline to week 16. 11. Change in exploratory urinary biomarkers from baseline to week 16. 12. Change in systolic blood pressure from baseline to weeks 4, 8, 12 and 16. 13. Change in diastolic blood pressure from baseline to weeks 4, 8, 12 and 16. 14. Change in whole body insulin sensitivity from baseline to week 16. 15. Change in insulin resistance in skeletal muscle from baseline to week 16. Safety Variables: 1. Incidence of treatment-emergent level 2 and level 3 hypoglycaemic episodes o Level 2 – Glucose <54 mg/dL, with or without symptoms o Level 3 – A severe event characterised by altered mental and	—

Measure

Time frame

Main Objective: Pharmacodynamic Objective: To assess the molecular mechanism of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with type 2 diabetes and diabetic complications;Secondary Objective: Safety Objective: To assess the safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with type 2 diabetes and diabetic complications. Efficacy Objective: To assess the efficacy of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with type 2 diabetes and diabetic complications.;Primary end point(s): Outcome Measures: 1. Change in the mononuclear methylation pattern from baseline to week 16. 2. Change in miRNAs from baseline to week 16. 3. Change in HbA1c from baseline to weeks 4, 8, 12 and 16. 4. Change in fasting plasma glucose from baseline to weeks 4, 8, 12 and 16. 5. Proportion of patients achieving a HbA1c below 6.5% at weeks 4, 8, 12 and 16. 6. Proportion of patients achieving a HbA1c below 7.0% at weeks 4, 8, 12 and 16. 7. Change in urinary albumin/creatinine ratio (UACR) from baseline to week 16. 8. Change in the signs and symptoms of diabetic peripheral neuropathy from baseline to week 16. 9. Change in high-sensitivity C-reactive protein (hsCRP) from baseline to week 16. 10. Change in exploratory serum and plasma biomarkers from baseline to week 16. 11. Change in exploratory urinary biomarkers from baseline to week 16. 12. Change in systolic blood pressure from baseline to weeks 4, 8, 12 and 16. 13. Change in diastolic blood pressure from baseline to weeks 4, 8, 12 and 16. 14. Change in whole body insulin sensitivity from baseline to week 16. 15. Change in insulin resistance in skeletal muscle from baseline to week 16. Safety Variables: 1. Incidence of treatment-emergent level 2 and level 3 hypoglycaemic episodes o Level 2 – Glucose <54 mg/dL, with or without symptoms o Level 3 – A severe event characterised by altered mental and

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Germany

Contacts

Public ContactRegulatory Affairs Department

Afimmune

afimmune.regulatory@afimmune.com+35312946380

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026