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

Study identifier:DFA102

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

overweight

Phase

Phase 2

Healthy volunteers

Study drug

pramlintide acetate, metreleptin, placebo-P, placebo-M

Sex

All

Actual Enrollment

636

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Apr 2008

Primary Completion Date: 01 Apr 2009

Study Completion Date: 01 Oct 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo-P + Placebo-M Placebo matched to pramlintide BID plus placebo matched to metreleptin BID	Drug: placebo-P subcutaneous injection, twice a day Other Name: Placebo matched to pramlintide Drug: placebo-M subcutaneous injection, twice a day Other Name: Placebo matched to Metreleptin
Experimental: Pramlintide 360 mcg + Placebo-M 360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID	Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: placebo-M subcutaneous injection, twice a day Other Name: Placebo matched to Metreleptin
Experimental: Placebo-P + Metreleptin 5.0 mg Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID	Drug: metreleptin subcutaneous injection, twice a day Drug: placebo-P subcutaneous injection, twice a day Other Name: Placebo matched to pramlintide
Experimental: Pramlintide 180 mcg + Metreleptin 2.5 mg Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID	Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day
Experimental: Pramlintide 180 mcg + Metreleptin 5.0 mg Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID	Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day
Experimental: Pramlintide 360 mcg + Metreleptin 1.25 mg Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID	Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day
Experimental: Pramlintide 360 mcg + Metreleptin 2.5 mg Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID	Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day
Experimental: Pramlintide 360 mcg + Metreleptin 5.0 mg Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID	Drug: pramlintide acetate subcutaneous injection, twice a day Other Name: Smylin Drug: metreleptin subcutaneous injection, twice a day

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Vice President Research and Development

Amylin Pharmaceuticals