Current partner codePEPTIDESDE
NCT00392925·Phase 2·INTERVENTIONAL

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

Status

Completed

Phase

Phase 2

Enrollment

177

Locations

12

Results

Posted

Publications

1

Study summary

What the protocol is testing.

This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.

Interventions

Treatment arms and agents.

DRUG

pramlintide acetate 360 mcg

subcutaneous injection, twice a day, 360mcg

DRUG

metreleptin

subcutaneous injection, twice a day, 5mg

DRUG

placebo-pramlintide 600 uL

twice a day

DRUG

placebo-metreleptin 1 mL

twice a day

DRUG

Pramlintide acetate 180 mcg

subcutaneous injection twice a day, 180 mcg

Timeline

From registration to results.

  1. First posted

    Oct 26, 2006

  2. Study start

    Oct 2006

  3. Primary completion

    Sep 2007

  4. Study completion

    Sep 2007

  5. Results posted

    Feb 28, 2014

  6. Registry updated

    Apr 14, 2015

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
ALL
Healthy volunteers
No

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

12 registered sites.

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

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.