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:
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00392925
First received: October 24, 2006
Last updated: September 19, 2011
Last verified: September 2011
  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