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NCT02639286 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension
A Phase 2 study of Lipodystrophy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT02639286: Completed Phase 2 study of Lipodystrophy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02639286 is a Phase 2 study of Lipodystrophy that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 5 participants, below the 133-participant average among 11 other Lipodystrophy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02639286, a Phase 2 study of Lipodystrophy, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Partial lipodystrophy is a deficiency of body fat in parts of the body (usually the arms and legs). People with partial lipodystrophy often get high blood triglyceride (fat) level, insulin resistance, diabetes and other problems. Researchers think the new drug ISIS 304801 can help treat health problems caused by partial lipodystrophy. Objective: To see if ISIS 304801 will improve blood fat (triglyceride levels), diabetes, and liver disease, and reduce some risks for heart disease caused by partial lipodystrophy. Eligibility: Adults at least 18 years old with partial lipodystrophy. Design: Participants will be screened during a 1-week stay at NIH. They will have: Blood and urine tests Physical exam. Assignment to get either the study drug or placebo. Instructions for how to inject the drug. Body measurements. Heart tests. Participants will give themselves injections of the drug or placebo once a week at home. Some may test blood sugar by finger pricks. They will have monthly phone calls and nurse visits to take blood tests. After 4 months, participants may continue the study for 1 year. All participants will get the study drug. Participants will have study visits at NIH every 4 months. These may include: Insulin sensitivity measurement: Insulin and sugar will be infused through 2 intravenous (IV) lines in the arms. Blood will be drawn. Sugar and fat metabolism measured by IV infusions and blood tests. Special x-ray scan to measure body fat. Liquid meal then blood collected by IV catheter in the arm. Magnetic resonance imaging scans. Neck ultrasound. Questionnaires. Liver biopsy (optional) Injection of heparin (a blood thinner) before a blood test. After finishing the drug, participants will have 1 nurse visit and 1 visit to NIH. ...
Primary Outcome
Change from baseline to 16 weeks in log 10 fasting triglycerides
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ISIS 304801
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 2 |
What the finished NCT02639286 record still lists
NCT02639286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 11 other Lipodystrophy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Lipodystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02639286 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02639286 about?
NCT02639286 is a clinical study titled "Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension". Background: Partial lipodystrophy is a deficiency of body fat in parts of the body (usually the arms and legs). People with partial lipodystrophy often get high blood triglyceride (fat) level, insulin resistance, diabetes and other problems. Researchers think the new drug ISIS 304801 can help treat...
What is the current status of trial NCT02639286?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2015-12-23. Estimated completion is 2019-09-26.
What conditions does trial NCT02639286 study?
This clinical trial studies the following conditions: Lipodystrophy.
What interventions are being tested in trial NCT02639286?
The interventions under investigation include: Placebo (DRUG), ISIS 304801 (DRUG).
Who is sponsoring clinical trial NCT02639286?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02639286 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lipodystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02639286's enrollment target sits among peer trials
5 12th of 11 the lowest of 11 other Lipodystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lipodystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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