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A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00112021
First received: May 27, 2005
Last updated: April 9, 2015
Last verified: April 2015
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Purpose
This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
| Condition | Intervention | Phase |
|---|---|---|
| Obesity | Drug: pramlintide acetate | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
| Official Title: | A Phase 2B, Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging, Multicenter Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To examine the effect of pramlintide on body weight in obese subjects [ Time Frame: Approximately 16 weeks ]
- To examine the safety and tolerability of pramlintide in obese subjects [ Time Frame: Approximately 16 weeks ]
Secondary Outcome Measures:
- To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters [ Time Frame: Approximately 16 weeks ]
| Enrollment: | 400 |
| Study Start Date: | May 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pramlintide Acetate |
Drug: pramlintide acetate
Other Name: Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection
|
| Placebo Comparator: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening.
- Usually consumes at least three major meals (morning, midday, and evening) each day.
Exclusion Criteria:
- Is currently enrolled in a formal weight-loss program.
- Has had liposuction within 1 year before screening or is planning to have liposuction during the study.
- Has received any investigational drug within 3 months before screening.
- Has previously participated in a study using pramlintide.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112021
Show 21 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112021
Show 21 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00112021 History of Changes |
| Other Study ID Numbers: |
137OB-201 |
| Study First Received: | May 27, 2005 |
| Last Updated: | April 9, 2015 |
Keywords provided by AstraZeneca:
|
obesity weight loss Amylin pramlintide Symlin |
Additional relevant MeSH terms:
|
Body Weight Signs and Symptoms Pramlintide Islet Amyloid Polypeptide Hypoglycemic Agents |
Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Amylin Receptor Agonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017