A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Amylin Pharmaceuticals, LLC..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01235741
First received: November 2, 2010
Last updated: March 16, 2011
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Pramlintide+Metreleptin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- To examine the effect on body weight of 16 weeks of treatment with pramlintide+metreleptin in obese subjects by assessing the absolute and percent change in body weight from baseline. [ Time Frame: 16-weeks ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of pramlintide+metreleptin in obese subjects by examination of number of adverse events and serious adverse events. [ Time Frame: 16-weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Pramlintide+Metreleptin
|
Drug: Pramlintide+Metreleptin
Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.
|
|
Placebo Comparator: Group B
Placebo
|
Drug: Placebo
Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is obese with a BMI ≥35 to ≤45 kg/m2.
- Has stable body weight (not varying by >5% within 3 months prior to study start).
- Meets certain requirements with respect to concomitant medications.
- Has not smoked or used nicotine-containing products for at least 12 months prior to study start.
Exclusion Criteria:
- Has not been enrolled in a weight loss program within 2 months prior to study start.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235741
Locations
| United States, California | |
| Research Site | |
| Greenbrae, California, United States | |
| Research Site | |
| La Jolla, California, United States | |
| United States, Colorado | |
| Research Site | |
| Denver, Colorado, United States | |
| United States, Florida | |
| Research Site | |
| Winter Park, Florida, United States | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States | |
| United States, Louisiana | |
| Research Site | |
| Baton Rouge, Louisiana, United States | |
| United States, Maryland | |
| Research Site | |
| Hyattsville, Maryland, United States | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States | |
| United States, Montana | |
| Research Site | |
| Butte, Montana, United States | |
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| United States, Oklahoma | |
| Research Site | |
| Tulsa, Oklahoma, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Research Site | |
| Austin, Texas, United States | |
| United States, Utah | |
| Research Site | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Research Site | |
| Arlington, Virginia, United States | |
| Research Site | |
| Norfolk, Virginia, United States | |
| Research Site | |
| Richmond, Virginia, United States | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Takeda Pharmaceuticals North America, Inc.
Investigators
| Study Director: | Senior Vice President, Research & Development | Amylin Pharmaceuticals, LLC. |
More Information
No publications provided
| Responsible Party: | Senior Vice President, Research & Development, Amylin Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01235741 History of Changes |
| Other Study ID Numbers: | DFA104 |
| Study First Received: | November 2, 2010 |
| Last Updated: | March 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
Pramlintide Metreleptin Obesity Amylin Takeda |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Pramlintide Islet Amyloid Polypeptide |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013