A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
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ClinicalTrials.gov Identifier: NCT00112021 |
Recruitment Status :
Completed
First Posted : May 30, 2005
Last Update Posted : April 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Drug: pramlintide acetate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
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 |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | November 2005 |
Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters [ Time Frame: Approximately 16 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112021

Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
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 |
First Posted: | May 30, 2005 Key Record Dates |
Last Update Posted: | April 10, 2015 |
Last Verified: | April 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 |