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:
Amylin Pharmaceuticals, LLC.
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
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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
Show 36 Study LocationsSponsors 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