Trial · NCT03371355
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
NCT03371355, Phase 2, Completed, Akcea Therapeutics; results first posted 2021-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease. Trials, record NCT03371355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03371355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
- NCT number
- NCT03371355
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- Akcea Therapeutics
- Conditions
- NAFLD, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Fatty Liver, Nonalcoholic
- Interventions
- Placebo, ISIS 703802 40 mg, ISIS 703802 80 mg, ISIS 703802 20 mg
- First posted
- 2017-12-13
- Last updated
- 2021-02-01
- Results first posted
- 2021-02-01
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100. |
| Secondary | Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Percent Change From Baseline in ANGPTL3, TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, ApoAI, FFA, and Lp(a) at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the log ratio of Primary Analysis Time Point to Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Primary Analysis Time Point to Baseline - 1) × 100. |
| Secondary | Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Change From Baseline in Fasting Insulin at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
| Secondary | Change From Baseline in and HOMA-IR at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | HOMA-IR is a method used to quantify insulin resistance. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) \* fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement. An ANCOVA model was performed on the change from Baseline to Primary Analysis Time Point. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | μg/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, 'number analyzed' (n) signifies participants evaluable for this outcome measure for each specified category. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Free Fatty Acid (FFA) at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lipoprotein(a) (Lp[a]) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | nmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in ANGPTL3, TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, ApoAI, FFA, and Lp(a) at Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, 'n' signifies participants evaluable for this outcome measure for each specified category. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin A1c (HbA1c) at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Insulin at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | milli-international units per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in and HOMA-IR at the Primary Analysis Time Point | Baseline, Week 27 for Cohort A, and Week 25 for Cohorts B and C | FAS population included all participants who were randomized and received at least 1 dose of study drug. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | index | LEAST_SQUARES_MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group212
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Pooled Placebo | -16 | 95% Confidence Interval -29 to 0 | percent change | |
| Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Cohort B: ISIS 703802, 40 mg Q4W | -36 | 95% Confidence Interval -47 to -23 | percent change | |
| Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Cohort C: ISIS 703802, 80 mg Q4W | -53 | 95% Confidence Interval -60 to -43 | percent change | |
| Percent Change From Baseline in Fasting Triglycerides Level at the Primary Analysis Time Point | Cohort A: ISIS 703802, 20 mg QW | -47 | 95% Confidence Interval -57 to -35 | percent change | |
| Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Pooled Placebo | 6.77 | 95% Confidence Interval -2.09 to 15.62 | μg/L | |
| Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Cohort B: ISIS 703802, 40 mg Q4W | -43.11 | 95% Confidence Interval -52.27 to -33.94 | μg/L | |
| Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Cohort C: ISIS 703802, 80 mg Q4W | -64.89 | 95% Confidence Interval -74.26 to -55.53 | μg/L | |
| Change From Baseline in Angiopoietin-Like 3 Protein at the Primary Analysis Time Point | Cohort A: ISIS 703802, 20 mg QW | -52.98 | 95% Confidence Interval -63.99 to -41.96 | μg/L | |
| Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point | Pooled Placebo | TC | -4.8 | 95% Confidence Interval -15.19 to 5.51 | mg/dL |
| Change From Baseline in TC, LDL-C, HDL-C, VLDL-C, Non-HDL-C, ApoB (ApoB-48, ApoB-100), ApoCIII, and ApoAI at the Primary Analysis Time Point | Cohort B: ISIS 703802, 40 mg Q4W | TC | -21.3 | 95% Confidence Interval -32.35 to -10.31 | mg/dL |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pooled Placebo | 27 | |
| Overall Study | STARTED | Cohort B: ISIS 703802, 40 mg Q4W | 26 | |
| Overall Study | STARTED | Cohort C: ISIS 703802, 80 mg Q4W | 26 | |
| Overall Study | STARTED | Cohort A: ISIS 703802, 20 mg QW | 26 | |
| Overall Study | COMPLETED | Pooled Placebo | 26 | |
| Overall Study | COMPLETED | Cohort B: ISIS 703802, 40 mg Q4W | 24 | |
| Overall Study | COMPLETED | Cohort C: ISIS 703802, 80 mg Q4W | 22 | |
| Overall Study | COMPLETED | Cohort A: ISIS 703802, 20 mg QW | 19 | |
| Overall Study | NOT COMPLETED | Pooled Placebo | 1 | |
| Overall Study | NOT COMPLETED | Cohort B: ISIS 703802, 40 mg Q4W | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
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 | Injection site pruritus | General disorders | Pooled Placebo | 0 | 27 | |
| other | Injection site pruritus | General disorders | Cohort B: ISIS 703802, 40 mg Q4W | 1 | 26 | |
| other | Injection site pruritus | General disorders | Cohort C: ISIS 703802, 80 mg Q4W | 8 | 26 | |
| other | Injection site pruritus | General disorders | Cohort A: ISIS 703802, 20 mg QW | 2 | 26 | |
| other | Injection site erythema | General disorders | Pooled Placebo | 0 | 27 | |
| other | Injection site erythema | General disorders | Cohort B: ISIS 703802, 40 mg Q4W | 1 | 26 | |
| other | Injection site erythema | General disorders | Cohort C: ISIS 703802, 80 mg Q4W | 6 | 26 | |
| other | Injection site erythema | General disorders | Cohort A: ISIS 703802, 20 mg QW | 2 | 26 | |
| other | Pyrexia | General disorders | Pooled Placebo | 0 | 27 | |
| other | Pyrexia | General disorders | Cohort B: ISIS 703802, 40 mg Q4W | 0 | 26 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pooled Placebo | 0 | 27 |
| Total, all-cause mortality | Cohort B: ISIS 703802, 40 mg Q4W | 0 | 26 |
| Total, all-cause mortality | Cohort C: ISIS 703802, 80 mg Q4W | 0 | 26 |
| Total, all-cause mortality | Cohort A: ISIS 703802, 20 mg QW | 0 | 26 |
| Total, other adverse events | Pooled Placebo | 13 | 27 |
| Total, other adverse events | Cohort B: ISIS 703802, 40 mg Q4W | 15 | 26 |
| Total, other adverse events | Cohort C: ISIS 703802, 80 mg Q4W | 20 | 26 |
| Total, other adverse events | Cohort A: ISIS 703802, 20 mg QW | 14 | 26 |
| Total, serious adverse events | Pooled Placebo | 1 | 27 |
| Total, serious adverse events | Cohort B: ISIS 703802, 40 mg Q4W | 1 | 26 |
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/NCT03371355
GET https://conductscience.org/api/trials/v1/NCT03371355/registered?page=2