Trial · NCT03514420
Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)
NCT03514420, Phase 2, Completed, Akcea Therapeutics; results first posted 2021-02-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL). Trials, record NCT03514420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03514420
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)
- NCT number
- NCT03514420
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Akcea Therapeutics
- Conditions
- Familial Partial Lipodystrophy
- Interventions
- AKCEA-ANGPTL3-LRx
- First posted
- 2018-05-02
- Last updated
- 2021-02-16
- Results first posted
- 2021-02-16
Source ClinicalTrials.gov
Registered outcomes43
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 Levels at End of the Treatment (Week 27) | Baseline and End of the Treatment (Week 27) | The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. |
| Secondary | Change From Baseline in Area Under the Curve (AUC) of Plasma Glucose as Assessed by Mixed Meal Test (MMT) at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the area under the curve (AUC) of Plasma Glucose was assessed. |
| Secondary | Change From Baseline in AUC of Serum Insulin as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of Serum Insulin was assessed. |
| Secondary | Change From Baseline in AUC of Serum C-peptide as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of Serum C-peptide was assessed. |
| Secondary | Change From Baseline in AUC of Free Fatty Acid (FFA) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of FFA was assessed. |
| Secondary | Change From Baseline in AUC of Serum Ghrelin as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of Serum Ghrelin was assessed. |
| Secondary | Change From Baseline in AUC of Incretin Hormone (Gastric Inhibitory Polypeptide [GIP]) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of Incretin Hormone: GIP was assessed. |
| Secondary | Change From Baseline in AUC of Incretin Hormone (Glucagon-like Peptide -1 [GLP-1]) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of Incretin Hormone: GLP-1 was assessed. |
| Secondary | Change From Baseline in AUC of Peptide Tyrosine Tyrosine (PYY) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | Change from Baseline to Week 27 in the AUC of PYY was assessed. |
| Secondary | Change From Baseline in HDL-C at End of the Treatment | Baseline and End of the Treatment (Week 27) | The baseline was defined as the average of Day 1 pre-dose fasting assessment and the last fasting measurement prior to Day 1 pre-dose fasting assessment. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
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 Levels at End of the Treatment (Week 27) | Baseline and End of the Treatment (Week 27) | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | percent change | MEAN |
| SECONDARY | Change From Baseline in Area Under the Curve (AUC) of Plasma Glucose as Assessed by Mixed Meal Test (MMT) at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Serum Insulin as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | milli international units per liter*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Serum C-peptide as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | ng/mL*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Free Fatty Acid (FFA) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | mEq/L*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Serum Ghrelin as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | pg/mL*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Incretin Hormone (Gastric Inhibitory Polypeptide [GIP]) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | pg/mL*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Incretin Hormone (Glucagon-like Peptide -1 [GLP-1]) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | pmol/L*min | MEAN |
| SECONDARY | Change From Baseline in AUC of Peptide Tyrosine Tyrosine (PYY) as Assessed by MMT at End of the Treatment | Baseline and End of the Treatment (Week 27) | 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. | pg/mL*min | MEAN |
| SECONDARY | Change From Baseline in HDL-C at End of the Treatment | Baseline and End of the Treatment (Week 27) | Safety set included all participants who were enrolled and received at least 1 dose of study drug. | mg/dL | MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group63
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 Levels at End of the Treatment (Week 27) | AKCEA-ANGPTL3-LRx 20 mg | -59.9 | Standard Deviation 26.29 | percent change | |
| Change From Baseline in Area Under the Curve (AUC) of Plasma Glucose as Assessed by Mixed Meal Test (MMT) at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | -9815.0 | Standard Deviation 4071.43 | mg/dL*min | |
| Change From Baseline in AUC of Serum Insulin as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | 3262.0 | Standard Deviation 3775.09 | milli international units per liter*min | |
| Change From Baseline in AUC of Serum C-peptide as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | -192.3 | Standard Deviation 257.10 | ng/mL*min | |
| Change From Baseline in AUC of Free Fatty Acid (FFA) as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | -60.0 | Standard Deviation 42.52 | mEq/L*min | |
| Change From Baseline in AUC of Serum Ghrelin as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | 8479.5 | Standard Deviation 7241.20 | pg/mL*min | |
| Change From Baseline in AUC of Incretin Hormone (Gastric Inhibitory Polypeptide [GIP]) as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | -1694.7 | Standard Deviation 11752.50 | pg/mL*min | |
| Change From Baseline in AUC of Incretin Hormone (Glucagon-like Peptide -1 [GLP-1]) as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | 1677.3 | Standard Deviation 11301.79 | pmol/L*min | |
| Change From Baseline in AUC of Peptide Tyrosine Tyrosine (PYY) as Assessed by MMT at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | 6549.0 | Standard Deviation 10632.50 | pg/mL*min | |
| Change From Baseline in HDL-C at End of the Treatment | AKCEA-ANGPTL3-LRx 20 mg | 2.1 | Standard Deviation 6.88 | mg/dL |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 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 | 4 | |
| Overall Study | COMPLETED | AKCEA-ANGPTL3-LRx 20 mg | 4 | |
| Overall Study | NOT COMPLETED | AKCEA-ANGPTL3-LRx 20 mg | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Hot flush | Vascular disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 4 | |
| other | Albumin urine present | Investigations | AKCEA-ANGPTL3-LRx 20 mg | 3 | 4 | |
| other | Antinuclear antibody positive | Investigations | AKCEA-ANGPTL3-LRx 20 mg | 1 | 4 | |
| other | Gamma-glutamyltransferase increased | Investigations | AKCEA-ANGPTL3-LRx 20 mg | 2 | 4 | |
| other | Hepatic steatosis | Hepatobiliary disorders | AKCEA-ANGPTL3-LRx 20 mg | 2 | 4 | |
| other | Blood magnesium decreased | Investigations | AKCEA-ANGPTL3-LRx 20 mg | 3 | 4 | |
| other | Creatinine urine increased | Investigations | AKCEA-ANGPTL3-LRx 20 mg | 1 | 4 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | AKCEA-ANGPTL3-LRx 20 mg | 2 | 4 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | AKCEA-ANGPTL3-LRx 20 mg | 1 | 4 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse 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 | 4 |
| Total, other adverse events | AKCEA-ANGPTL3-LRx 20 mg | 4 | 4 |
| Total, serious adverse events | AKCEA-ANGPTL3-LRx 20 mg | 3 | 4 |
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/NCT03514420
GET https://conductscience.org/api/trials/v1/NCT03514420/registered?page=2