HypertriglyceridemiaPhase 2TRIAGENCT04365400
Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
A Phase 2 study testing DS102 in people with Hypertriglyceridemia and Type 2 Diabetes, run by Afimmune at 56 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia, Type 2 Diabetes
- What is being tested?
- DS102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 56 sitesin 6 countries
- Study dates
- 13 Oct 2020to 3 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 20Show fewer
- 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.
- 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.
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
56 sites in 6 countries.
56 sites in 6 countries
United States32 sites
US Site 15
Adairsville, Georgia, 30103
US Site 2
Albany, New York, 12203
US Site 35
Ames, Iowa, 50010
US Site 23
Cerritos, California, 90703
US Site 7
Dallas, Texas, 75231
US Site 22
Edmond, Oklahoma, 73013
US Site 8
Fort Worth, Texas, 76107
US Site 14
Fort Worth, Texas, 76164
US Site 25
Hickory, North Carolina, 28601
US Site 24
Houston, Texas, 77036
US Site 30
Houston, Texas, 77061
US Site 6
Houston, Texas, 77079
US Site 33
Houston, Texas, 77099
US Site 18
Huntington Park, California, 90255
US Site 12
Jackson, Tennessee, 38301
US Site 5
Little Rock, Arkansas, 72204
US Site 19
Los Angeles, California, 90057
US Site 29
Missouri City, Texas, 77459
US Site 11
Morehead City, North Carolina, 28557
US Site 31
North Richland Hills, Texas, 76180
US Site 20
Panorama City, California, 91402
US Site 34
Raleigh, North Carolina, 27609
US Site 26
Rocky Mount, North Carolina, 27804
US Site 28
Salisbury, North Carolina, 28144
US Site 21
Santa Ana, California, 92704
US Site 13
Santa Ana, California, 92705
US Site 32
Statesville, North Carolina, 28625
US Site 10
Waco, Texas, 76708
US Site 27
Wilmington, North Carolina, 28601
US Site 17
Winchester, Virginia, 22601
US Site 1
Wyomissing, Pennsylvania, 19610
US Site 3
Yardley, Pennsylvania, 19067
Israel8 sites
Israel Site 9
Herzliya
Israel Site 1
Holon
Israel Site 5
Jerusalem
Israel Site 6
Jerusalem
Israel Site 4
Nahariya
Israel Site 8
Sakhnin
Israel Site 2
Tel Aviv
Israel Site 3
Tel Aviv
Georgia4 sites
Georgia Site 1
Batumi
Georgia Site 2
Kutaisi
Georgia Site 3
Kutaisi
Georgia Site 4
Tbilisi
Germany4 sites
Germany Site 7
Dresden
Germany Site 3
Hamburg
Germany Site 1
Heidelberg
Germany Site 5
Lübeck
Latvia4 sites
Latvia Site 4
Ogre
Latvia Site 1
Riga
Latvia Site 2
Riga
Latvia Site 3
Riga
Switzerland4 sites
Switzerland Site 3
Lausanne
Switzerland Site 4
Lucerne
Switzerland Site 2
Olten
Switzerland Site 1
Sankt Gallen
About this study
Official title: 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
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
Read the detailed description
This was a randomised, double-blind, Placebo-controlled, 3-arm, multi-centre Phase IIb study consisting of 26 weeks of active treatment and a 2-week post-treatment follow-up period in adult patients with hypertriglyceridemia and concomitant type 2 diabetes.
The screening period consisted of up to 6-weeks lead-in during which all patients were to undergo diet and lifestyle stabilisation, washout of disallowed medications and optimisation of statins.
After screening, patients were randomised (1:1:1) at the baseline visit into the following treatment groups:
- Treatment Group A (Placebo): four Placebo capsules orally administered twice a day, i.e., eight capsules daily for 26 weeks.
- Treatment Group B (Epeleuton 2g): two Epeleuton 500 mg capsules and two Placebo capsules orally administered twice a day, i.e., eight capsules daily for 26 weeks.
- Treatment Group C (Epeleuton 4g): four Epeleuton 500 mg capsules orally administered twice a day, i.e., eight capsules daily for 26 weeks.
The observation period was 32-34 weeks (lead-in: 4-6 weeks, treatment duration: 26 weeks, follow-up period: 2 weeks). During the study, 10 visits to the clinic were scheduled: two screening visits (Visit 1 and Visit 2), one visit at the start of the comparative treatment period (baseline/Visit 3), six visits in the comparative treatment period (Visit 4/Week 4, Visit 5/Week 8, Visit 6/Week 12, Visit 7/Week 16, Visit 8/Week 20 and Visit 9/Week 26 or Early Termination) and one final safety follow-up visit (Visit 10/Week 28).
- Conditions
- Hypertriglyceridemia, Type 2 Diabetes
- Being tested
- DS102, Placebo
- Medical subject headings
- Hypertriglyceridemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS102Drug
Also called Epeleuton Capsules
DS102 Epeleuton capsules
PlaceboDrug
Also called Placebo Capsules
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| DS102 2000mg | Experimental | Participants in this group received 1000mg DS102 capsules twice daily. Receives: Drug: DS102 |
| DS102 4000mg | Experimental | Participants in this group received 2000mg DS102 capsules twice daily. Receives: Drug: DS102 |
| Placebo | Placebo comparator | Participants in this group received placebo capsules twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 26 weeks
Secondary outcomes (2)
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Percent change in triglycerides from baseline to weeks 4, 8, 12, 20 and 26
Measured: 26 weeks
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Change in HbA1c (glycosylated haemoglobin) from baseline to weeks 4, 8, 12, 16 and 20
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start13 Oct 2020
- Primary completion3 May 2022
- Study completion3 May 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Weissbach, MD, Study director, Afimmune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365400
- Sponsor's protocol ID
- DS102A-07-CV1
- Other IDs
- 2020-000065-16
- Acronym
- TRIAGE
- Status last verified
- Jun 2023
- First submitted
- 24 Apr 2020
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04365400
- Acronym / sponsor ID
- TRIAGE / DS102A-07-CV1
- Conditions
- Hypertriglyceridemia, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 233 participants (actual)
- Lead sponsor
- AfimmuneIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This was a randomised, double-blind, Placebo-controlled, 3-arm, multi-centre Phase IIb study consisting of 26 weeks of active treatment and a 2-week post-treatment follow-up period in adult patients with hypertriglyceridemia and concomitant type 2 diabetes.
The screening period consisted of up to 6-weeks lead-in during which all patients were to undergo diet and lifestyle stabilisation, washout of disallowed medications and optimisation of statins.
After screening, patients were randomised (1:1:1) at the baseline visit into the following treatment groups:
- Treatment Group A (Placebo): four Placebo capsules orally administered twice a day, i.e., eight capsules daily for 26 weeks.
- Treatment Group B (Epeleuton 2g): two Epeleuton 500 mg capsules and two Placebo capsules orally administered twice a day, i.e., eight capsules daily for 26 weeks.
- Treatment Group C (Epeleuton 4g): four Epeleuton 500 mg capsules orally administered twice a day, i.e., eight capsules daily for 26 weeks.
The observation period was 32-34 weeks (lead-in: 4-6 weeks, treatment duration: 26 weeks, follow-up period: 2 weeks). During the study, 10 visits to the clinic were scheduled: two screening visits (Visit 1 and Visit 2), one visit at the start of the comparative treatment period (baseline/Visit 3), six visits in the comparative treatment period (Visit 4/Week 4, Visit 5/Week 8, Visit 6/Week 12, Visit 7/Week 16, Visit 8/Week 20 and Visit 9/Week 26 or Early Termination) and one final safety follow-up visit (Visit 10/Week 28).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DS102 2000mg | Experimental | Drug: DS102Participants in this group received 1000mg DS102 capsules twice daily. |
| DS102 4000mg | Experimental | Drug: DS102Participants in this group received 2000mg DS102 capsules twice daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this group received placebo capsules twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS102Also: Epeleuton CapsulesDS102 Epeleuton capsules | Drug | DS102 2000mg, DS102 4000mg |
| PlaceboAlso: Placebo CapsulesPlacebo capsules | Drug | Placebo |
Primary outcome
Percent Change in Triglycerides From Baseline to Week 16
Time frame: 16 weeks
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.
Change in HbA1c From Baseline to Week 26
Time frame: 26 weeks
Changes from baseline of HbA1c at each visit were analysed using mixed model analysis of covariance (ANCOVA) with baseline value as a covariate.
2 secondary outcomes
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26
Time frame: 26 weeks
Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Weissbach, MD study director
Afimmune
56 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS102 in people with Hypertriglyceridemia and Type 2 Diabetes, run by Afimmune at 56 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Israel, Georgia, Germany, Latvia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Triglycerides From Baseline to Week 16 (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.