Trial · NCT04365400

Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes

NCT04365400, Phase 2, Terminated, Afimmune; results first posted 2023-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes. Trials, record NCT04365400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04365400

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
NCT number: NCT04365400
Status: Terminated
Phases: Phase 2
Enrollment: 233 participants, actual
Lead sponsor: Afimmune
Conditions: Hypertriglyceridemia, Type 2 Diabetes
Interventions: DS102, Placebo
First posted: 2020-04-28
Last updated: 2023-06-12
Other registries' IDs: eudract:2020-000065-16
Results first posted: 2023-06-01

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in Triglycerides From Baseline to Week 16	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.
Primary	Change in HbA1c From Baseline to Week 26	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.
Secondary	% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26	26 weeks	Percent change in triglycerides from baseline to weeks 4, 8, 12, 20 and 26
Secondary	Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20	20 weeks	Change in HbA1c (glycosylated haemoglobin) from baseline to weeks 4, 8, 12, 16 and 20

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Triglycerides From Baseline to Week 16	16 weeks	Full Analysis Set (FAS):~Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.	% Change in TG	MEAN
PRIMARY	Change in HbA1c From Baseline to Week 26	26 weeks	Full Analysis Set (FAS):~Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.	% of HbA1c	MEAN
SECONDARY	% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26	26 weeks	Full Analysis Set (FAS):~Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.	% Change in TG	MEAN
SECONDARY	Change in HbA1c From Baseline to Weeks 4, 8, 12, 16 and 20	20 weeks	Full Analysis Set (FAS):~Patients were included in the FAS, a modified intention-to-treat population, if they were randomised to the study, received at least one dose of study medication and had at least one post-baseline measurement.	% HbA1c	MEAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change in Triglycerides From Baseline to Week 16	DS102 2000mg		-7.886	Standard Error 4.096	% Change in TG
Percent Change in Triglycerides From Baseline to Week 16	DS102 4000mg		5.273	Standard Error 5.361	% Change in TG
Percent Change in Triglycerides From Baseline to Week 16	Placebo		-5.130	Standard Error 4.945	% Change in TG
Change in HbA1c From Baseline to Week 26	DS102 2000mg		-2.255	Standard Error 1.412	% of HbA1c
Change in HbA1c From Baseline to Week 26	DS102 4000mg		-0.524	Standard Error 1.162	% of HbA1c
Change in HbA1c From Baseline to Week 26	Placebo		-0.503	Standard Error 1.446	% of HbA1c
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26	DS102 2000mg	Week 4 - Baseline	-9.301	Standard Error 3.994	% Change in TG
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26	DS102 4000mg	Week 4 - Baseline	5.965	Standard Error 9.868	% Change in TG
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26	Placebo	Week 4 - Baseline	-6.025	Standard Error 4.479	% Change in TG
% Change in Triglycerides From Baseline to Weeks 4, 8, 12, 20 and 26	DS102 2000mg	Week 8 - Baseline	-5.018	Standard Error 3.843	% Change in TG

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	DS102 2000mg	79
Overall Study	STARTED	DS102 4000mg	77
Overall Study	STARTED	Placebo	77
Overall Study	COMPLETED	DS102 2000mg	49
Overall Study	COMPLETED	DS102 4000mg	50
Overall Study	COMPLETED	Placebo	50
Overall Study	NOT COMPLETED	DS102 2000mg	30
Overall Study	NOT COMPLETED	DS102 4000mg	27
Overall Study	NOT COMPLETED	Placebo	27

Source ClinicalTrials.gov

Adverse events435

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	DS102 2000mg	8	79
other	Diarrhoea	Gastrointestinal disorders	DS102 4000mg	13	77
other	Diarrhoea	Gastrointestinal disorders	Placebo	6	77
other	Nausea	Gastrointestinal disorders	DS102 2000mg	2	79
other	Nausea	Gastrointestinal disorders	DS102 4000mg	6	77
other	Nausea	Gastrointestinal disorders	Placebo	3	77
other	Dyspepsia	Gastrointestinal disorders	DS102 2000mg	3	79
other	Dyspepsia	Gastrointestinal disorders	DS102 4000mg	2	77
other	Dyspepsia	Gastrointestinal disorders	Placebo	2	77
other	Abdominal Pain	Gastrointestinal disorders	DS102 2000mg	1	79

1 to 10 of 435Source ClinicalTrials.gov

See all 435 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DS102 2000mg	0	79
Total, all-cause mortality	DS102 4000mg	0	77
Total, all-cause mortality	Placebo	0	77
Total, other adverse events	DS102 2000mg	49	79
Total, other adverse events	DS102 4000mg	52	77
Total, other adverse events	Placebo	42	77
Total, serious adverse events	DS102 2000mg	1	79
Total, serious adverse events	DS102 4000mg	0	77
Total, serious adverse events	Placebo	1	77

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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