Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00673387
First received: May 6, 2008
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate SC injection in obese and overweight subjects.


Condition Intervention Phase
Overweight
Obesity
Drug: pramlintide
Drug: metreleptin
Drug: placebo 1
Drug: placebo 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects.

Resource links provided by NLM:


Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Percent change in body weight [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
    Percent change in body weight after 28 weeks of therapy (i.e., body weight at 28 weeks minus body weight at baseline divided by body weight at baseline times 100%).


Secondary Outcome Measures:
  • Investigate effect of various doses of metreleptin and pramlintide, administered alone or in combination, in overweight and obese subjects on waist circumference; fasting circulating metabolic parameters; and patient-reported outcomes [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Examine the pharmacokinetics of metreleptin and pramlintide, administered alone or in combination (as separate SC injections), in obese and overweight subjects [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: baseline and 28 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline following 28 weeks of therapy.


Enrollment: 636
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo 1
subcutaneous injection, twice a day, low dose
Drug: placebo 2
subcutaneous injection, twice a day
Placebo Comparator: 2 Drug: placebo 1
subcutaneous injection, twice a day, middle dose
Drug: placebo 2
subcutaneous injection, twice a day
Placebo Comparator: 3 Drug: placebo 1
subcutaneous injection, twice a day, high dose
Drug: placebo 2
subcutaneous injection, twice a day
Experimental: 4 Drug: pramlintide
subcutaneous injection, twice a day, high dose
Drug: placebo 1
subcutaneous injection, twice a day, low dose
Experimental: 5 Drug: pramlintide
subcutaneous injection, twice a day, high dose
Drug: placebo 1
subcutaneous injection, twice a day, middle dose
Experimental: 6 Drug: pramlintide
subcutaneous injection, twice a day, high dose
Drug: placebo 1
subcutaneous injection, twice a day, high dose
Experimental: 7 Drug: metreleptin
subcutaneous injection, twice a day, high dose
Drug: placebo 2
subcutaneous injection, twice a day
Experimental: 8 Drug: pramlintide
subcutaneous injection, twice a day, high dose
Drug: metreleptin
subcutaneous injection, twice a day, low dose
Experimental: 9 Drug: pramlintide
subcutaneous injection, twice a day, high dose
Drug: metreleptin
subcutaneous injection, twice a day, middle dose
Experimental: 10 Drug: pramlintide
subcutaneous injection, twice a day, high dose
Drug: metreleptin
subcutaneous injection, twice a day, high dose
Experimental: 11 Drug: pramlintide
subcutaneous injection, twice a day, low dose
Drug: metreleptin
subcutaneous injection, twice a day, middle dose
Experimental: 12 Drug: metreleptin
subcutaneous injection, twice a day, high dose
Drug: pramlintide
subcutaneous injection, twice a day, low dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 65 years old.
  • Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight (BMI>=27kg/m^2 and <30kg/m^2.
  • Has stable body weight, i.e., not varying by >3% within 3 months prior to study.
  • Has not been treated over the past 3 months or is currently treated with any of the following medications: Oral contraceptives (female subjects); Hormone replacement therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement therapy; selective serotonin reuptake inhibitors (SSRIs).
  • Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study.
  • Is a nonsmoker (has not smoked for at least 6 months prior to the study).

Exclusion Criteria:

  • Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics suggestive of genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet-Biedl syndrome).
  • 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 *antiobesity agents (prescription or over-the-counter), *antipsychotic agents, *antiepileptic agents, *antidepressant agents, *drugs that directly affect gastrointestinal motility, *antidiabetic medications.
  • Has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®).
  • 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 had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study.
  • Has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673387

  Show 36 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
Study Director: Vice President Research and Development, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00673387     History of Changes
Other Study ID Numbers: DFA102
Study First Received: May 6, 2008
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
overweight
obesity
pramlintide
metreleptin
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 16, 2013