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NCT Number: NCT00402077

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pramlintide acetate

Drug

subcutaneous injection, three times a day, 120mcg

Other names: Symlin

sibutramine

Drug

oral tablet, once a day, 10mg

Other names: Meridia

Phentermine

Drug

oral tablet, once a day, 37.5mg

Other names: Adipex-P, Fastin, Obenix, Oby-Trim

Placebo

Drug

subcutaneous injection, three times a day

Primary outcomes

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

    Time frame: 24 weeks

  2. Absolute change in body weight from baseline to Week 12

    Time frame: 12 weeks

Secondary outcomes

  1. Percent change in body weight from baseline to Week 12

    Time frame: 12 weeks

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

    Time frame: 24 weeks

  3. 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

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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