DRUG
pramlintide acetate 360 mcg
subcutaneous injection, twice a day, 360mcg
Status
Completed
Phase
Phase 2
Enrollment
177
Locations
12
Results
Posted
Publications
1
Study summary
This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.
Interventions
DRUG
subcutaneous injection, twice a day, 360mcg
DRUG
subcutaneous injection, twice a day, 5mg
DRUG
twice a day
DRUG
twice a day
DRUG
subcutaneous injection twice a day, 180 mcg
Timeline
First posted
Oct 26, 2006
Study start
Oct 2006
Primary completion
Sep 2007
Study completion
Sep 2007
Results posted
Feb 28, 2014
Registry updated
Apr 14, 2015
Outcomes
Mean Absolute Change From Baseline to Week 16 in Body Weight - Evaluable Population
Time frame · Baseline to Week 16
Absolute change in body weight as measured in kilograms (kg) from baseline to Week 16. Baseline defined as Day 1 of randomized treatment.
LS Mean Percent Change in Body Weight From Baseline to Weeks 4, 8, 12, 16, and 20 - Evaluable Population
Time frame · Baseline up to Week 20
Least Squares (LS) mean percent change in body weight from baseline to Weeks 4 through 20. Baseline defined as Day 1 of randomized treatment.
LS Mean Absolute Change From Baseline to Weeks 4, 8, 12, 20 in Body Weight - Evaluable Population
Time frame · Baseline to Week 20
Least Squares (LS) mean absolute change in body weight as measured in kilograms (kg) from baseline to Weeks 4, 8, 12, 20. Baseline defined as Day 1 of randomized treatment
LS Mean Absolute Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population
Time frame · Enrollment to Week 20
Least Squares (LS) mean change in body weight as measured in kilograms (kg) from enrollment to each study visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and the participant was treated as per that arm up to Week 20.
LS Mean Percent Change in Body Weight From Enrollment to Weeks 4, 8, 12, 16, and 20 - Evaluable Population
Time frame · Enrollment to Week 20
Least Squares (LS) mean percent change is percentage that body weight changed over time at each visit. Enrollment was Visit 2 (Week -4) which was the start of the Lead-In Period. After the 4 week Lead-In Period, at Day 1, the participant was randomized to one of the 3 study arms and treated up to Week 20.
Initial, Late, and Overall Rates of LS Mean Absolute Change in Body Weight From Day 1 to Week 20 - Evaluable Population
Time frame · Baseline to Week 20
Initial (Day 1 through Week 12), late (Week 12 through Week 20), and overall (Day 1 through Week 20) rates of Least squares (LS) mean absolute change in body weight were defined by the slopes of the regression lines fitted to the observed body weights during the periods from Baseline (Day 1) through each visit to Week 20. Initial, late and overall absolute change was measured in kilograms of body weight per week (kg/week). Baseline refers to Visit 4 (Day 1 of randomization period).
Number of Participants Achieving at Least 5% and at Least 10% Body Weight Loss From Baseline to Weeks 16 and 20, and Number of Participants With Sustained Weight Loss in Each Category - Evaluable Population
Time frame · Baseline to Weeks 16 and Weeks 20
Baseline refers to Visit 4 (Day 1 of randomization period). Number of participants with 5% or more and 10% or more change in weight from baseline at each visit. Number of participants with 5% or more change in weight that was sustained through Week 16. Number of participants with 10% or more change in weight that was sustained through Week 20.
LS Mean Percent Change in Weight From Enrollment to Baseline and LS Mean Percent Change in Excess Weight From Enrollment to Baseline - Evaluable Population
Time frame · Enrollment to Baseline
Excess body weight: the difference between a participant's actual body weight and the weight a participant of his/her height would have if his/her BMI were 24.9 kg/m2. Excess body weight at a given visit was calculated as body weight in kilograms (kg) at that visit minus 24.9 × height in meters (m)\^2 or 0, whichever was greater. If a participant achieved a normal BMI (24.9 kg/m\^2), that subject was considered to have no excess weight. Additional weight loss that occurred after a normal BMI was achieved was not included in the calculation of excess weight loss. Enrollment was Visit 2 (Week -4), the start of the Lead-In Period. Baseline was Day 1 of the randomization to a study arm.
LS Mean Absolute Change in Waist Circumference From Enrollment to Weeks 4, 8, 12, 16, 20 - Evaluable Population
Time frame · Enrollment to Week 20
Waist circumference was measured in centimeters (cm). Least Squares mean = LS mean. Enrollment was Visit 2 (Week -4) which was the start of the 4 week Lead-In Period. At Day 1, the participant was randomized to one of the 3 study arms and the participant was treated up to Week 20.
LS Mean Absolute Change in Waist Circumference From Baseline to Weeks 4, 8, 12, 16, 20 - Evaluable Population
Time frame · Baseline to Week 20
Baseline was Visit 4 (Day 1 of randomization period). Waist circumference was measured in centimeters (cm).
LS Mean Absolute Change in Hip Circumference From Screening up to Week 20 - Evaluable Population
Time frame · Screening up to Week 20
Screening (Week -5 or -6) was the first visit for a participant. This first visit determined participant eligibility and occurred prior to enrollment (Week -4). Hip circumference was measured in centimeters (cm).
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
DeLand, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Edina, Minnesota, United States
Research Site
Butte, Montana, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Olympia, Washington, United States
Publications
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