Current partner codePEPTIDESDE
NCT00402077·Phase 2·INTERVENTIONAL

A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Status

Completed

Phase

Phase 2

Enrollment

258

Locations

16

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.

Interventions

Treatment arms and agents.

DRUG

pramlintide acetate

subcutaneous injection, three times a day, 120mcg

DRUG

sibutramine

oral tablet, once a day, 10mg

DRUG

phentermine

oral tablet, once a day, 37.5mg

DRUG

placebo

subcutaneous injection, three times a day

Timeline

From registration to results.

  1. First posted

    Nov 22, 2006

  2. Study start

    Nov 2006

  3. Primary completion

    Aug 2007

  4. Study completion

    Aug 2007

  5. Results posted

    Not reported

  6. Registry updated

    Mar 6, 2015

Outcomes

What the study measures.

Primary outcomes

All treatment-emergent adverse events occurring during the 24-week treatment period

Time frame · 24 weeks

Absolute change in body weight from baseline to Week 12

Time frame · 12 weeks

Secondary outcomes

Percent change in body weight from baseline to Week 12

Time frame · 12 weeks

Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24

Time frame · 24 weeks

Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24

Time frame · 24 weeks

Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24

Time frame · 24 weeks

Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24

Time frame · 24 weeks

Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24

Time frame · 24 weeks

Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24

Time frame · 24 weeks

Eligibility

Who can take part.

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

Inclusion Criteria: * Is obese with a Body Mass Index (BMI) \>=30 kg/m\^2 to \<=50 kg/m\^2 or overweight with a BMI \>=27 kg/m\^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions) * Has been obese or overweight for at least one year prior to study start * Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: \*hormone replacement therapy; \*oral contraceptives; \*lipid-lowering agents; \*thyroid replacement therapy; \*metformin Exclusion Criteria: * Is currently enrolled in or is planning to enroll in a formal weight-loss program * Is unwilling or unable to participate in a lifestyle intervention program as part of the study * Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: \*prescription or over the counter antiobesity agents (within the 6 months prior to study start); \*psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); \*steroids that are known to result in high systemic absorption; \*calcitonin; \*ketoconazole; \*antidiabetic medications * Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study * Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start * Has previously used pramlintide either by prescription or as part of a clinical study * Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start * Has donated blood within 2 months before study start, or is planning to donate blood during the study

Study locations

16 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Chula Vista, California, United States

Research Site

La Jolla, California, United States

Research Site

Los Angeles, California, United States

Research Site

Walnut Creek, California, United States

Research Site

Miami, Florida, United States

Research Site

Pembroke Pines, Florida, United States

Research Site

Louisville, Kentucky, United States

Research Site

New York, New York, United States

Research Site

Raleigh, North Carolina, United States

Research Site

Statesville, North Carolina, United States

Research Site

Eugene, Oregon, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Austin, Texas, United States

Research Site

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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.