Trial · NCT03360747
Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
NCT03360747, Phase 2, Completed, Akcea Therapeutics; results first posted 2021-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS). Trials, record NCT03360747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03360747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Chylomicronemia Syndrome (FCS)
- NCT number
- NCT03360747
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Akcea Therapeutics
- Conditions
- Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
- Interventions
- AKCEA-ANGPTL3-LRx
- First posted
- 2017-12-04
- Last updated
- 2021-01-07
- Results first posted
- 2021-01-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) | Baseline to Month 3 | Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Primary | Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG) | Baseline to Month 3 | Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Secondary | Absolute Change From Baseline to Month 3 in Fasting Angiopoietin-Like 3 (ANGPTL3) | Baseline to Month 3 | Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Secondary | Percent Change From Baseline to Month 3 in Fasting Angiopoietin-like 3 (ANGPTL3) | Baseline to Month 3 | Baseline was defined as the average of Day 1 predose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Secondary | Fasting Lipid and Lipoprotein Measurements at Month 3 | Month 3 | Fasting lipid and lipoprotein measurements included non-HDL-C, ApoB, HDL-C, ApoA-1, VLDL-C and LDL-C. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Secondary | Absolute Change From Baseline to Month 3 in Other Fasting Lipid Parameters | Baseline to Month 3 | Other fasting lipid measurements included total cholesterol (TC), non-HDL-C, ApoB, HDL-C, ApoA-1, VLDL-C, and LDL-C. Baseline was defined as average of Day 1 predose fasting assessment and last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Secondary | Percent (%) Change From Baseline to Month 3 in Other Fasting Lipid Parameters | Baseline to Month 3 | Other fasting lipid measurements included TC, non-HDL-C, ApoB, HDL-C, ApoA-1, VLDL-C, and LDL-C. Baseline was defined as average of Day 1 predose fasting assessment and last fasting measurement prior to Day 1 pre-dose fasting assessment. Month 3 was defined as the average of Week 13 and Week 14 fasting assessments. |
| Secondary | Change From Baseline to Day 92 in Maximum Postprandial Triglycerides (TG) | Baseline to Day 92 | Participants consumed standardized pre-cooked meals (lunches and dinners and instructions for breakfasts and snacks) for 2 days prior to the postprandial assessments. Change from Baseline to Day 92 in maximum postprandial TG was assessed. |
| Secondary | Number of Participants Who Experienced Abdominal Pain During the Treatment Period | Days 1, 29, 57 and 92 | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From time of informed consent to end of follow-up period (Up to Week 26) | An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. A TEAE was defined as any AE starting on or after the first dose of the study drug. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) | Baseline to Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | mg/dL | MEAN |
| PRIMARY | Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG) | Baseline to Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | percent change | MEAN |
| SECONDARY | Absolute Change From Baseline to Month 3 in Fasting Angiopoietin-Like 3 (ANGPTL3) | Baseline to Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | ng/mL | MEAN |
| SECONDARY | Percent Change From Baseline to Month 3 in Fasting Angiopoietin-like 3 (ANGPTL3) | Baseline to Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | percent change | MEAN |
| SECONDARY | Fasting Lipid and Lipoprotein Measurements at Month 3 | Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | mg/dL | MEAN |
| SECONDARY | Absolute Change From Baseline to Month 3 in Other Fasting Lipid Parameters | Baseline to Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | mg/dL | MEAN |
| SECONDARY | Percent (%) Change From Baseline to Month 3 in Other Fasting Lipid Parameters | Baseline to Month 3 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | percent change | MEAN |
| SECONDARY | Change From Baseline to Day 92 in Maximum Postprandial Triglycerides (TG) | Baseline to Day 92 | Safety set included all participants who were enrolled 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 | MEAN |
| SECONDARY | Number of Participants Who Experienced Abdominal Pain During the Treatment Period | Days 1, 29, 57 and 92 | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From time of informed consent to end of follow-up period (Up to Week 26) | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline to Month 3 in Fasting Triglycerides (TG) | AKCEA-ANGPTL3-LRx 20 mg | -550.00 | Standard Deviation 431.471 | mg/dL | |
| Percent Change From Baseline to Month 3 in Fasting Triglycerides (TG) | AKCEA-ANGPTL3-LRx 20 mg | -32.83 | Standard Deviation 31.994 | percent change | |
| Absolute Change From Baseline to Month 3 in Fasting Angiopoietin-Like 3 (ANGPTL3) | AKCEA-ANGPTL3-LRx 20 mg | -31.983 | Standard Deviation 5.4773 | ng/mL | |
| Percent Change From Baseline to Month 3 in Fasting Angiopoietin-like 3 (ANGPTL3) | AKCEA-ANGPTL3-LRx 20 mg | -51.249 | Standard Deviation 4.9093 | percent change | |
| Fasting Lipid and Lipoprotein Measurements at Month 3 | AKCEA-ANGPTL3-LRx 20 mg | Non-HDL-C | 217.33 | Standard Deviation 119.618 | mg/dL |
| Fasting Lipid and Lipoprotein Measurements at Month 3 | AKCEA-ANGPTL3-LRx 20 mg | ApoB | 64.53 | Standard Deviation 4.899 | mg/dL |
| Fasting Lipid and Lipoprotein Measurements at Month 3 | AKCEA-ANGPTL3-LRx 20 mg | HDL-C | 13.0 | Standard Deviation 1.00 | mg/dL |
| Fasting Lipid and Lipoprotein Measurements at Month 3 | AKCEA-ANGPTL3-LRx 20 mg | ApoA-1 | 77.3 | Standard Deviation 6.03 | mg/dL |
| Fasting Lipid and Lipoprotein Measurements at Month 3 | AKCEA-ANGPTL3-LRx 20 mg | VLDL-C | 190.17 | Standard Deviation 128.861 | mg/dL |
| Fasting Lipid and Lipoprotein Measurements at Month 3 | AKCEA-ANGPTL3-LRx 20 mg | LDL-C | 27.17 | Standard Deviation 10.324 | mg/dL |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AKCEA-ANGPTL3-LRx 20 mg | 3 | |
| Overall Study | COMPLETED | AKCEA-ANGPTL3-LRx 20 mg | 2 | |
| Overall Study | NOT COMPLETED | AKCEA-ANGPTL3-LRx 20 mg | 1 |
Source ClinicalTrials.gov
Adverse events10
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 | Asthenia | General disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Influenza like illness | General disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Headache | Nervous system disorders | AKCEA-ANGPTL3-LRx 20 mg | 2 | 3 | |
| other | Vertigo positional | Ear and labyrinth disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Influenza | Infections and infestations | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Hyperlipidaemia | Metabolism and nutrition disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Loss of libido | Psychiatric disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 | |
| other | Mood swings | Psychiatric disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AKCEA-ANGPTL3-LRx 20 mg | 0 | 3 |
| Total, other adverse events | AKCEA-ANGPTL3-LRx 20 mg | 3 | 3 |
| Total, serious adverse events | AKCEA-ANGPTL3-LRx 20 mg | 0 | 3 |
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.
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/NCT03360747
GET https://conductscience.org/api/trials/v1/NCT03360747/results?page=2