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NCT00819234 · ClinicalTrials.gov registry record · Phase 2
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 274
- Enrollment target
NCT00819234: Completed Phase 2 study, sponsored by AstraZeneca.
NCT00819234 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 274 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819234, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 274 participants
- Enrollment target
Study Summary
Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.
Primary Outcome
Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance
Interventions
- DRUG Placebo
- DRUG Pramlintide and Metreleptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00819234 record still lists
NCT00819234 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00819234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00819234 about?
NCT00819234 is a clinical study titled "Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin". Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, admi...
What is the current status of trial NCT00819234?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2008-11. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00819234?
The interventions under investigation include: Placebo (DRUG), Pramlintide and Metreleptin (DRUG).
Who is sponsoring clinical trial NCT00819234?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00819234's enrollment target sits among peer trials
274 203rd of 2000 higher than 1,797 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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