Trial · NCT03011450
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
NCT03011450, Phase 3, Completed, Kowa Research Institute, Inc.; results first posted 2022-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment. Trials, record NCT03011450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03011450
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
- NCT number
- NCT03011450
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 471 participants, actual
- Lead sponsor
- Kowa Research Institute, Inc.
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- K-877, Fenofibrate, Placebo (for K-877)
- First posted
- 2017-01-05
- Last updated
- 2022-10-28
- Results first posted
- 2022-10-28
Source ClinicalTrials.gov
Registered outcomes114
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Fasting TG From Baseline to Week 12 | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Remnant Cholesterol | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in HDL-C | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Apo A1 | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Non-HDL-C | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in LDL-C | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in FFAs | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Apo A2 | 12 Weeks | |
| Secondary | Percent Change From Baseline to Week 12 in Apo B | 12 Weeks |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 registered outcomesOutcomes114
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Fasting TG From Baseline to Week 12 | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in Remnant Cholesterol | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in HDL-C | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in Apo A1 | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in Non-HDL-C | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in Total Cholesterol | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in LDL-C | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in FFAs | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in Apo A2 | 12 Weeks | Percent change | MEDIAN | |
| SECONDARY | Percent Change From Baseline to Week 12 in Apo B | 12 Weeks | Percent change | MEDIAN |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 outcomesResults by group228
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Fasting TG From Baseline to Week 12 | K-877 | -58.89 | Inter-Quartile Range -71.69 to -38.42 | Percent change | |
| Percent Change in Fasting TG From Baseline to Week 12 | Placebo | -22.94 | Inter-Quartile Range -43.98 to 9.67 | Percent change | |
| Percent Change From Baseline to Week 12 in Remnant Cholesterol | K-877 | -55.51 | Inter-Quartile Range -71.29 to -33.64 | Percent change | |
| Percent Change From Baseline to Week 12 in Remnant Cholesterol | Placebo | -13.29 | Inter-Quartile Range -43.30 to 9.76 | Percent change | |
| Percent Change From Baseline to Week 12 in HDL-C | K-877 | 23.50 | Inter-Quartile Range 5.24 to 45.13 | Percent change | |
| Percent Change From Baseline to Week 12 in HDL-C | Placebo | 7.33 | Inter-Quartile Range -4.00 to 18.79 | Percent change | |
| Percent Change From Baseline to Week 12 in Apo A1 | K-877 | 4.05 | Inter-Quartile Range -5.57 to 14.62 | Percent change | |
| Percent Change From Baseline to Week 12 in Apo A1 | Placebo | 0.00 | Inter-Quartile Range -7.80 to 10.01 | Percent change | |
| Percent Change From Baseline to Week 12 in Non-HDL-C | K-877 | -20.98 | Inter-Quartile Range -34.70 to -4.06 | Percent change | |
| Percent Change From Baseline to Week 12 in Non-HDL-C | Placebo | -3.43 | Inter-Quartile Range -23.66 to 6.75 | Percent change |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12-week Efficacy | STARTED | K-877 | 311 | |
| 12-week Efficacy | STARTED | Placebo/Fenofibrate | 159 | |
| 12-week Efficacy | COMPLETED | K-877 | 299 | |
| 12-week Efficacy | COMPLETED | Placebo/Fenofibrate | 159 | |
| 12-week Efficacy | NOT COMPLETED | K-877 | 12 | |
| 12-week Efficacy | NOT COMPLETED | Placebo/Fenofibrate | 0 | |
| 40-week Extension | STARTED | K-877 | 292 | |
| 40-week Extension | STARTED | Placebo/Fenofibrate | 154 | |
| 40-week Extension | COMPLETED | K-877 | 275 | |
| 40-week Extension | COMPLETED | Placebo/Fenofibrate | 146 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events212
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 | Events |
|---|---|---|---|---|---|---|
| other | Glomerular filtration rate decreased | Investigations | K-877: 12-Week Efficacy | 0 | 311 | |
| other | Glomerular filtration rate decreased | Investigations | Placebo:12-Week Efficacy | 0 | 159 | |
| other | Glomerular filtration rate decreased | Investigations | K-877: 40-Week Extension | 2 | 292 | |
| other | Glomerular filtration rate decreased | Investigations | Fenofibrate 40-Week Extension | 8 | 154 | |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | K-877: 12-Week Efficacy | 0 | 311 | |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Placebo:12-Week Efficacy | 0 | 159 | |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | K-877: 40-Week Extension | 0 | 292 | |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Fenofibrate 40-Week Extension | 1 | 154 | |
| serious | Acute myocardial infarction | Cardiac disorders | K-877: 12-Week Efficacy | 1 | 311 | |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo:12-Week Efficacy | 0 | 159 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | K-877: 12-Week Efficacy | 3 | 311 |
| Total, all-cause mortality | Placebo:12-Week Efficacy | 0 | 159 |
| Total, all-cause mortality | K-877: 40-Week Extension | 3 | 292 |
| Total, all-cause mortality | Fenofibrate 40-Week Extension | 1 | 154 |
| Total, other adverse events | K-877: 12-Week Efficacy | 0 | 311 |
| Total, other adverse events | Placebo:12-Week Efficacy | 0 | 159 |
| Total, other adverse events | K-877: 40-Week Extension | 2 | 292 |
| Total, other adverse events | Fenofibrate 40-Week Extension | 8 | 154 |
| Total, serious adverse events | K-877: 12-Week Efficacy | 11 | 311 |
| Total, serious adverse events | Placebo:12-Week Efficacy | 3 | 159 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03011450
GET https://conductscience.org/api/trials/v1/NCT03011450/registered?page=2