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NCT01235741 · ClinicalTrials.gov registry record · Phase 2
A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
A Phase 2 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 2
- Development phase
- 213
- Enrollment target
NCT01235741: Clinical Trial Phase 2 study, sponsored by AstraZeneca.
NCT01235741 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 213 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235741, a Phase 2 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 213 participants
- Enrollment target
Study Summary
Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.
Primary Outcome
Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.
Interventions
- DRUG Placebo
- DRUG Pramlintide+Metreleptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT01235741 stopped before completion
NCT01235741 is an interventional study that assigns participants to a tested intervention. The registered 213 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 (60% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01235741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01235741 about?
NCT01235741 is a clinical study titled "A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects". Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-w...
What is the current status of trial NCT01235741?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 213 participants. The study started on 2011-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01235741?
The interventions under investigation include: Placebo (DRUG), Pramlintide+Metreleptin (DRUG).
Who is sponsoring clinical trial NCT01235741?
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 NCT01235741's enrollment target sits among peer trials
213 290th of 2000 higher than 1,711 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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