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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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 2

Conditions

Overweight
Obesity

Treatments

Drug: sibutramine
Drug: pramlintide acetate
Drug: phentermine
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

258 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

258 participants in 4 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: pramlintide acetate
2
Experimental group
Treatment:
Drug: sibutramine
Drug: pramlintide acetate
3
Experimental group
Treatment:
Drug: phentermine
Drug: pramlintide acetate
4
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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