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Clinical Trial Details

Trial ID: L5715
Source ID: NCT04365400
Associated Drug: Ds102
Title: Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
Acronym: TRIAGE
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04365400/results
Conditions: Hypertriglyceridemia|Type 2 Diabetes
Interventions: DRUG: DS102|DRUG: Placebo
Outcome Measures: Primary: 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: % 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, 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, 20 weeks
Sponsor/Collaborators: Sponsor: Afimmune
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 233
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-10-13
Completion Date: 2022-05-03
Results First Posted: 2023-06-01
Last Update Posted: 2023-06-12
Locations: 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, H̱olon, Israel|Israel Site 5, Jerusalem, Israel|Israel Site 6, Jerusalem, Israel|Israel Site 4, Nahariya, Israel|Israel Site 8, Sakhnīn, 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, Luzern, Switzerland|Switzerland Site 2, Olten, Switzerland|Switzerland Site 1, Saint Gallen, Switzerland
URL: https://clinicaltrials.gov/show/NCT04365400

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress