Study Stopped
Trial prematurely terminated on 03 May 2022 due to the results from an interim analysis indicating a lack of efficacy in the study population.
Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
TRIAGE
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
2 other identifiers
interventional
233
6 countries
56
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2020
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
October 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2022
CompletedResults Posted
Study results publicly available
June 1, 2023
CompletedJune 12, 2023
June 1, 2023
1.6 years
April 24, 2020
May 5, 2023
June 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change in Triglycerides From Baseline to Week 16
Analysis of changes and percentage changes of triglycerides was performed using a Wilcoxon rank sum test with the Hodges Lehmann median and 95% confidence intervals estimates. For analysis of triglycerides, baseline was defined as the mean of the Baseline (Visit 3) and Screening 2/Week -1 (Visit 2) measurements.
16 weeks
Change in HbA1c From Baseline to Week 26
Changes from baseline of HbA1c at each visit were analysed using mixed model analysis of covariance (ANCOVA) with baseline value as a covariate.
26 weeks
Secondary Outcomes (2)
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
26 weeks
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
20 weeks
Study Arms (3)
DS102 2000mg
EXPERIMENTALParticipants in this group received 1000mg DS102 capsules twice daily.
DS102 4000mg
EXPERIMENTALParticipants in this group received 2000mg DS102 capsules twice daily.
Placebo
PLACEBO COMPARATORParticipants in this group received placebo capsules twice daily.
Interventions
Eligibility Criteria
You may qualify if:
- Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first screening visit.
- Patients with a HbA1C (glycosylated haemoglobin) between 7.0 - 10.0% (53-86 mmol/mol) (both inclusive)
- 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.
- 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.
- 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.
- Patients with an LDL cholesterol level \<130mg/dL (3.34 mmol/L) at both screening visits.
- Patients who have a body mass index (BMI) ≥ 25kg/m2 and \<50kg/m2.
- 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.
- 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.
- +2 more criteria
You may not qualify if:
- Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Afimmunelead
Study Sites (56)
US Site 5
Little Rock, Arkansas, 72204, United States
US Site 23
Cerritos, California, 90703, United States
US Site 18
Huntington Park, California, 90255, United States
US Site 19
Los Angeles, California, 90057, United States
US Site 20
Panorama City, California, 91402, United States
US Site 21
Santa Ana, California, 92704, United States
US Site 13
Santa Ana, California, 92705, United States
US Site 15
Adairsville, Georgia, 30103, United States
US Site 35
Ames, Iowa, 50010, United States
US Site 2
Albany, New York, 12203, United States
US Site 25
Hickory, North Carolina, 28601, United States
US Site 11
Morehead City, North Carolina, 28557, United States
US Site 34
Raleigh, North Carolina, 27609, United States
US Site 26
Rocky Mount, North Carolina, 27804, United States
US Site 28
Salisbury, North Carolina, 28144, United States
US Site 32
Statesville, North Carolina, 28625, United States
US Site 27
Wilmington, North Carolina, 28601, United States
US Site 22
Edmond, Oklahoma, 73013, United States
US Site 1
Wyomissing, Pennsylvania, 19610, United States
US Site 3
Yardley, Pennsylvania, 19067, United States
US Site 12
Jackson, Tennessee, 38301, United States
US Site 7
Dallas, Texas, 75231, United States
US Site 8
Fort Worth, Texas, 76107, United States
US Site 14
Fort Worth, Texas, 76164, United States
US Site 24
Houston, Texas, 77036, United States
US Site 30
Houston, Texas, 77061, United States
US Site 6
Houston, Texas, 77079, United States
US Site 33
Houston, Texas, 77099, United States
US Site 29
Missouri City, Texas, 77459, United States
US Site 31
North Richland Hills, Texas, 76180, United States
US Site 10
Waco, Texas, 76708, United States
US Site 17
Winchester, Virginia, 22601, United States
Georgia Site 1
Batumi, Georgia
Georgia Site 2
Kutaisi, Georgia
Georgia Site 3
Kutaisi, Georgia
Georgia Site 4
Tbilisi, Georgia
Germany Site 7
Dresden, Germany
Germany Site 3
Hamburg, Germany
Germany Site 1
Heidelberg, Germany
Germany Site 5
Lübeck, Germany
Israel Site 9
Herzliya, Israel
Israel Site 1
Holon, Israel
Israel Site 5
Jerusalem, Israel
Israel Site 6
Jerusalem, Israel
Israel Site 4
Nahariya, Israel
Israel Site 8
Sakhnin, Israel
Israel Site 2
Tel Aviv, Israel
Israel Site 3
Tel Aviv, Israel
Latvia Site 4
Ogre, Latvia
Latvia Site 1
Riga, Latvia
Latvia Site 2
Riga, Latvia
Latvia Site 3
Riga, Latvia
Switzerland Site 3
Lausanne, Switzerland
Switzerland Site 4
Lucerne, Switzerland
Switzerland Site 2
Olten, Switzerland
Switzerland Site 1
Sankt Gallen, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Afimmune
Study Officials
- STUDY DIRECTOR
Markus Weissbach, MD
Afimmune
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2020
First Posted
April 28, 2020
Study Start
October 13, 2020
Primary Completion
May 3, 2022
Study Completion
May 3, 2022
Last Updated
June 12, 2023
Results First Posted
June 1, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share