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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 is a Phase 2 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 213 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01235741
The ClinicalTrials.gov registry entry for NCT01235741 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01235741 reports 0 study locations.
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.
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