A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
Public ClinicalTrials.gov record NCT01235741. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controled, Multicenter Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects Following A Low-Calorie Diet Lead-In
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01235741
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 213 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2011 (Type not available)
- Primary completion
- Sep 2011 (Actual)
- Completion
- Sep 2011 (Actual)
- Last update posted
- Apr 15, 2015
2011
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Greenbrae | California | — | — |
| Research Site | La Jolla | California | — | — |
| Research Site | Denver | Colorado | — | — |
| Research Site | Winter Park | Florida | — | — |
| Research Site | Chicago | Illinois | — | — |
| Research Site | Baton Rouge | Louisiana | — | — |
| Research Site | Hyattsville | Maryland | — | — |
| Research Site | Boston | Massachusetts | — | — |
| Research Site | St Louis | Missouri | — | — |
| Research Site | Butte | Montana | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Tulsa | Oklahoma | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Austin | Texas | — | — |
| Research Site | Salt Lake City | Utah | — | — |
| Research Site | Arlington | Virginia | — | — |
| Research Site | Norfolk | Virginia | — | — |
| Research Site | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01235741, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 15, 2015 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01235741 live on ClinicalTrials.gov.