Trial · NCT02639286
Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
NCT02639286, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2020-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension. Trials, record NCT02639286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02639286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
- NCT number
- NCT02639286
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Lipodystrophy
- Interventions
- ISIS 304801, Placebo
- First posted
- 2015-12-24
- Last updated
- 2020-10-20
- Results first posted
- 2020-10-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Log 10 Fasting Triglycerides. | Baseline and 16 weeks | Change from baseline to 16 weeks in log 10 fasting triglycerides |
| Secondary | Change in Lipolysis Rate (Glycerol) | Baseline and 16 weeks | Change in lipolysis rate measured using stable isotope tracers (Glycerol rate of appearance) (mg/kgLBM/min) |
| Secondary | Change in Lipolysis Rate (Palmitate) | Baseline and 16 weeks | Change in lipolysis rate measured using stable isotope tracers (Palmitate rate of appearance) measured in milligrams per kilogram lean body mass per minute (mg/kgLBM/min) |
| Secondary | Change From Baseline in Liver Volume | Baseline and 16 weeks | Change from baseline in hepatic steatosis (magnetic resonance spectroscopy) (mL) |
| Secondary | Change From Baseline in Hepatic Steatosis | Baseline and 16 weeks | Change from baseline in hepatic steatosis via magnetic resonance spectroscopy |
| Secondary | Change in Lipoprotein Lipase Activity | Baseline and 16 weeks | Lipoprotein lipase activity in plasma is measured using blood samples obtained 10 minutes after intravenous infusion of 60 units/kg of unfractionated heparin. |
| Secondary | Change in Total Body Insulin Sensitivity | Baseline and 16 weeks | Change in total body insulin sensitivity using the hyperinsulinemic euglycemic clamp (mg/kgLBM/min) |
| Secondary | Change in HbA1c | Baseline and 16 weeks | Change in hemoglobin A1c (HbA1c) (%) |
| Secondary | Change in Fasting Plasma Glucose | Baseline and 16 weeks | Change in fasting plasma glucose in mg/dL |
| Secondary | Plasma ISIS 304801 Level | 16 weeks | Measured via a non-compartmental plasma PK analysis of ISIS 304801 |
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 | Change in Log 10 Fasting Triglycerides. | Baseline and 16 weeks | log 10 mg/dl | MEAN | |
| SECONDARY | Change in Lipolysis Rate (Glycerol) | Baseline and 16 weeks | mg/kgLBM/min | MEAN | |
| SECONDARY | Change in Lipolysis Rate (Palmitate) | Baseline and 16 weeks | mg/kgLBM/min | MEAN | |
| SECONDARY | Change From Baseline in Liver Volume | Baseline and 16 weeks | mL | MEAN | |
| SECONDARY | Change From Baseline in Hepatic Steatosis | Baseline and 16 weeks | percent | MEAN | |
| SECONDARY | Change in Lipoprotein Lipase Activity | Baseline and 16 weeks | nmol FFA/min | MEAN | |
| SECONDARY | Change in Total Body Insulin Sensitivity | Baseline and 16 weeks | mg/kgLBM/min | MEAN | |
| SECONDARY | Change in HbA1c | Baseline and 16 weeks | Percent | MEAN | |
| SECONDARY | Change in Fasting Plasma Glucose | Baseline and 16 weeks | mg/dL | MEAN | |
| SECONDARY | Plasma ISIS 304801 Level | 16 weeks | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Log 10 Fasting Triglycerides. | Placebo | 0.1 | Standard Deviation 0.2 | log 10 mg/dl | |
| Change in Log 10 Fasting Triglycerides. | ISIS 304801 | -0.2 | Standard Deviation 0.4 | log 10 mg/dl | |
| Change in Lipolysis Rate (Glycerol) | Placebo | 0.1 | Standard Deviation 0.6 | mg/kgLBM/min | |
| Change in Lipolysis Rate (Glycerol) | ISIS 304801 | 0.3 | Standard Deviation 2.0 | mg/kgLBM/min | |
| Change in Lipolysis Rate (Palmitate) | Placebo | 0.0 | Standard Deviation 0.1 | mg/kgLBM/min | |
| Change in Lipolysis Rate (Palmitate) | ISIS 304801 | -0.2 | Standard Deviation 0.0 | mg/kgLBM/min | |
| Change From Baseline in Liver Volume | Placebo | -114.5 | Standard Deviation 384.2 | mL | |
| Change From Baseline in Liver Volume | ISIS 304801 | 129.2 | Standard Deviation 145 | mL | |
| Change From Baseline in Hepatic Steatosis | Placebo | 4.6 | Standard Deviation 14.9 | percent | |
| Change From Baseline in Hepatic Steatosis | ISIS 304801 | -3.8 | Standard Deviation 0.92 | percent |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | STARTED | ISIS 304801 | 2 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | COMPLETED | ISIS 304801 | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | ISIS 304801 | 0 |
Source ClinicalTrials.gov
Adverse events24
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 reactions | Investigations | Placebo | 0 | 3 | |
| other | Injection site reactions | Investigations | ISIS 304801 | 2 | 2 | |
| other | Elevated liver enzymes | Hepatobiliary disorders | Placebo | 1 | 3 | |
| other | Elevated liver enzymes | Hepatobiliary disorders | ISIS 304801 | 1 | 2 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 3 | |
| other | Headache | Nervous system disorders | ISIS 304801 | 1 | 2 | |
| other | IV infiltration | Investigations | Placebo | 1 | 3 | |
| other | IV infiltration | Investigations | ISIS 304801 | 0 | 2 | |
| other | Urinary tract infection | Renal and urinary disorders | Placebo | 0 | 3 | |
| other | Urinary tract infection | Renal and urinary disorders | ISIS 304801 | 1 | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, all-cause mortality | ISIS 304801 | 0 | 2 |
| Total, other adverse events | Placebo | 3 | 3 |
| Total, other adverse events | ISIS 304801 | 2 | 2 |
| Total, serious adverse events | Placebo | 0 | 3 |
| Total, serious adverse events | ISIS 304801 | 1 | 2 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ISIS 304801 vs Placebo: deaths from any cause | Trial comparisons |
| ISIS 304801 vs Placebo: serious adverse events | Trial comparisons |
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/NCT02639286
GET https://conductscience.org/api/trials/v1/NCT02639286/events?page=2