A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00392925
First received: October 24, 2006
Last updated: September 19, 2011
Last verified: September 2011
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Purpose
This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.
| Condition | Intervention | Phase |
|---|---|---|
|
Overweight Obesity |
Drug: pramlintide acetate Drug: recombinant-methionyl human leptin 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 Phase 2A, Randomized, Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Effect on Body Weight of Recombinant-Methionyl Human Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- To compare the safety, tolerability, and effect on body weight of treatment with leptin and pramlintide versus pramlintide and placebo versus leptin and placebo in overweight and obese subjects [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To investigate the effect of treatment with leptin and pramlintide on the following: *waist circumference, *patient reported outcomes, *change in BMI, *change in excess body weight, and *pharmacokinetic (i.e., drug concentration in the blood) parameters [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 177 |
| Study Start Date: | October 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: recombinant-methionyl human leptin
subcutaneous injection, twice a day, 5mg
Drug: placebo
twice a day
|
| Experimental: 2 |
Drug: pramlintide acetate
subcutaneous injection, twice a day, 360mcg
Other Name: Symlin
Drug: placebo
twice a day
|
| Experimental: 3 |
Drug: pramlintide acetate
subcutaneous injection, twice a day, 360mcg
Other Name: Symlin
Drug: recombinant-methionyl human leptin
subcutaneous injection, twice a day, 5mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight (BMI>=27kg/m^2 and <30kg/m^2) with abdominal obesity, based on the following: *waist circumference >102 cm if male, *waist circumference >88 cm if female
- Is a nonsmoker (has not smoked for at least 6 months prior to the study)
- Consumes a morning and evening meal each day
Exclusion Criteria:
- Is diagnosed with type 2 diabetes
- Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion)
- Has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with any of the following medications: *antiobesity agents (prescription or over-the-counter), *antipsychotic agents, *antiepileptic agents, *antidepressant agents, *drugs that directly affect gastrointestinal motility
- Has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting
- Has previously received treatment with recombinant leptin or pramlintide
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392925
Locations
| United States, Florida | |
| Research Site | |
| Deland, Florida, United States | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Research Site | |
| Indianapolis, Indiana, United States | |
| United States, Kansas | |
| Research Site | |
| Overland Park, Kansas, United States | |
| United States, Louisiana | |
| Research Site | |
| Baton Rouge, Louisiana, United States | |
| United States, Michigan | |
| Research Site | |
| Detroit, Michigan, United States | |
| United States, Minnesota | |
| Research Site | |
| Edina, Minnesota, United States | |
| United States, Montana | |
| Research Site | |
| Butte, Montana, United States | |
| United States, Ohio | |
| Research Site | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States | |
| United States, Utah | |
| Research Site | |
| Salt Lake City, Utah, United States | |
| United States, Washington | |
| Research Site | |
| Olympia, Washington, United States | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
More Information
No publications provided
| Responsible Party: | Lisa Porter, MD, Study Director, Amylin Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00392925 History of Changes |
| Other Study ID Numbers: | DFA101 |
| Study First Received: | October 24, 2006 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
overweight obesity pramlintide leptin Amylin |
Additional relevant MeSH terms:
|
Body Weight Obesity Overweight Signs and Symptoms Overnutrition Nutrition Disorders 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