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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overweight; Obesity

Intervention: pramlintide acetate (Drug); metreleptin (Drug); placebo-P (Drug); placebo-M (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Vice President Research and Development, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.

Summary

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 subcutaneous (SC) injection in obese and overweight subjects.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Least Squares (LS) Mean Percent Change in Body Weight From Baseline to Week 28 - Evaluable Population

Secondary outcome:

Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Week 28 - Evaluable Population

Mean Absolute Change From Baseline to Weeks 4, 12, 28 in Mean Trough Concentration of Total Leptin - Evaluable Population

LS Mean Absolute Change in Body Weight From Baseline to Weeks 4, 12, and 28 - Evaluable Population

LS Mean Change in Waist Circumference From Baseline to Week 12 and Week 28 - Evaluable Population

Geometric Mean of the Total Area Under the Concentration Time Curve (AUC) From Time 0 to Last Quantifiable Concentration (Tlast) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide

Geometric Mean of AUC From Time 0 to Infinity for Pramlintide at Weeks 4 and 24 - Evaluable Population Treated With Pramlintide

Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) for Pramlintide at Weeks 4 and 24 - Evaluable Population Receiving Pramlintide

Least Squares (LS) Mean Absolute Change From Baseline to Week 28 in Percent of Body Fat - Evaluable Population

LS Mean Absolute Change From Baseline to Week 28 in Total Body Fat Mass (k) - Evaluable Population

LS Mean Absolute Change From Baseline to Week 28 in Fat-free Mass (kg) - Evaluable Population

LS Mean Absolute Change From Baseline to Week 28 in Fasting Plasma Glucose, Total Cholesterol (TC), Triglycerides, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol - Evaluable Population

Mean Absolute Change From Baseline to Week 28 for Insulin - Evaluable Population

Mean Absolute Change From Screening to Week 24 in Impact of Weight on Quality of Life Questionnaire-lite Version (IWQOL-Lite) Total Score - Evaluable Population

Mean Absolute Change From Screening to Week 24 in Binge Eating Scale (BES) Total Score - Evaluable Population

Mean Absolute Change From Screening to Week 24 in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Evaluable Population

Mean Absolute Change From Screening to Week 24 in Hospital Anxiety and Depression Scale (HADS) Total Scores - Evaluable Population

Mean Absolute Change From Screening to Week 24 in Summary Scores for Profile of Mood States - Brief (POMS-B) - Evaluable Population

Mean Absolute Change From Screening to Week 24 in Minutes to Fall Asleep, Hours of Sleep and The Pittsburgh Sleep Quality Index (PSQI) Global Score - Evaluable Population

Mean Absolute Change From Screening to Week 24 in the Epworth Sleepiness Scale (ESS) Total Score - Evaluable Population

Number of Hematology and Urinalysis Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population

Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From Screening to Week 28 - Intent to Treat Population

Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 28 - Intent to Treat Population

Mean Change in Heart Rate From Baseline to Week 28 - Intent to Treat Population

Number of Participants With Treatment-emergent Positive Anti-leptin Antibody Titers at Week 28 - Intent to Treat Population

Mean Change From Screening to Week 28 in Electrocardiogram Parameters - Intent to Treat Population

Mean Change From Screening to Week 28 in the Electrocardiogram Parameter of Heart Rate - Intent to Treat Population

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Birmingham, Alabama, United States

Research Site, Chandler, Arizona, United States

Research Site, Santa Rosa, California, United States

Research Site, Walnut Creek, California, United States

Research Site, Denver, Colorado, United States

Research Site, Jacksonville, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Pembrook Pines, Florida, United States

Research Site, Plantation, Florida, United States

Research Site, Atlanta, Georgia, United States

Research Site, Chicago, Illinois, United States

Research Site, Springfield, Illinois, United States

Research Site, Overland Park, Kansas, United States

Research Site, Baton Rouge, Louisiana, United States

Research Site, Auburn, Maine, United States

Research Site, Boston, Massachusetts, United States

Research Site, Edina, Minnesota, United States

Research Site, St. Louis, Missouri, United States

Research Site, Butte, Montana, United States

Research Site, New York City, New York, United States

Research Site, Statesville, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Columbus, Ohio, United States

Research Site, Eugene, Oregon, United States

Research Site, Medford, Oregon, United States

Research Site, Anderson, South Carolina, United States

Research Site, Greer, South Carolina, United States

Research Site, Mt. Pleasant, South Carolina, United States

Research Site, Nashville, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Dallas, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Salt Lake City, Utah, United States

Research Site, Norfolk, Virginia, United States

Research Site, Belingham, Washington, United States

Research Site, Olympia, Washington, United States

Additional Information

Starting date: April 2008
Last updated: March 26, 2015

Page last updated: August 23, 2015

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