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NCT00673387 · ClinicalTrials.gov registry record · Phase 2
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 636
- Enrollment target
NCT00673387: Completed Phase 2 study, sponsored by AstraZeneca.
NCT00673387 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 636 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (378% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00673387, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 636 participants
- Enrollment target
Study Summary
A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.
Primary Outcome
Body weight was measured in kilogram (kg). Baseline is defined as Day 1. If Day 1 was missing or after the first dose date of randomized treatment, the last available value prior to Day 1 was used. Drug Randomization stratified by sex and 3 categories baseline BMI (12 arms); 3 treatment arms combined for summaries as single placebo treatment group; 3 combined for summaries as single pramlintide monotherapy treatment group (total: 8 treatment groups).
Interventions
- DRUG metreleptin
- DRUG pramlintide acetate
- DRUG placebo-P
- DRUG placebo-M
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 636 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00673387 record still lists
NCT00673387 is an interventional study that assigns participants to a tested intervention. The registered 636 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 (378% higher).
The record links to 0 conditions, and to 4 interventions - of which metreleptin is the first listed.
NCT00673387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00673387 about?
NCT00673387 is a clinical study titled "Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects". A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.
What is the current status of trial NCT00673387?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 636 participants. The study started on 2008-04. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00673387?
The interventions under investigation include: metreleptin (DRUG), pramlintide acetate (DRUG), placebo-P (DRUG), placebo-M (DRUG).
Who is sponsoring clinical trial NCT00673387?
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 NCT00673387's enrollment target sits among peer trials
636 51st of 2000 higher than 1,950 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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