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NCT03371355 · ClinicalTrials.gov registry record · Phase 2
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
A Phase 2 study, sponsored by Akcea Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT03371355: Completed Phase 2 study, sponsored by Akcea Therapeutics.
NCT03371355 is a Phase 2 study that has completed, run by Akcea Therapeutics. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03371355, a Phase 2 study, has completed, sponsored by Akcea Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, Type 2 diabetes mellitus (T2DM), and nonalcoholic fatty liver disease (NAFLD).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG ISIS 703802 40 mg
- DRUG ISIS 703802 80 mg
- DRUG ISIS 703802 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2020-02-24 |
| Phase | Phase 2 |
What the finished NCT03371355 record still lists
NCT03371355 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03371355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03371355 about?
NCT03371355 is a clinical study titled "Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease". This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with ...
What is the current status of trial NCT03371355?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2017-12-21. Estimated completion is 2020-02-24.
What interventions are being tested in trial NCT03371355?
The interventions under investigation include: Placebo (DRUG), ISIS 703802 40 mg (DRUG), ISIS 703802 80 mg (DRUG), ISIS 703802 20 mg (DRUG).
Who is sponsoring clinical trial NCT03371355?
This trial is sponsored by Akcea Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03371355's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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