Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Intervention: pramlintide acetate; metreleptin; placebo-P; placebo-M
Intervention description: subcutaneous injection, twice a day; subcutaneous injection, twice a day; subcutaneous injection, twice a day; subcutaneous injection, twice a day
Intervention MeSH terms: Pramlintide; Islet Amyloid Polypeptide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 636.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: overweight; obesity; pramlintide; metreleptin; Amylin

Summary:

      A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety,
      tolerability and effect on body weight of a range of doses of metreleptin and pramlintide,
      each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 65 years old.

          -  Is obese (Body Mass Index [BMI]>=30kg/m^2 and <=35kg/m^2); or overweight
             (BMI>=27kg/m^2 and <30kg/m^2.

          -  Has stable body weight, i.e., not varying by >3% within 3 months prior to study.

          -  Has not been treated over the past 3 months or is currently treated with any of the
             following medications: Oral contraceptives (female subjects); Hormone replacement
             therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome
             (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement
             therapy; selective serotonin reuptake inhibitors (SSRIs).

          -  Is comfortable with having repeated telephone contacts with a lifestyle counselor
             during the study.

          -  Is a nonsmoker (has not smoked for at least 6 months prior to the study).

        Exclusion Criteria:

          -  Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics
             suggestive of genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome,
             Bardet-Biedl syndrome).

          -  Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program
             with the specific intent of losing weight (subjects who have been following an
             exercise regimen resulting in stable weight maintenance for at least 2 months prior to
             enrollment are eligible for study inclusion)

          -  Has been treated over the past 2 months, is currently treated, or is expected to
             require or undergo treatment with *antiobesity agents (prescription or
             over-the-counter), *antipsychotic agents, *antiepileptic agents, *antidepressant
             agents, *drugs that directly affect gastrointestinal motility, *antidiabetic
             medications.

          -  Has previously received treatment with metreleptin or pramlintide in a clinical study
             or has received prior treatment with pramlintide (SYMLIN®).

          -  Has received any investigational drug within 30 days or within a period corresponding
             to 5 half-lives of that drug, whichever is greater, prior to this study starting.

          -  Has had a major surgery or a blood transfusion, or has donated blood over the past 2
             months or is planning to donate blood during the study.

          -  Has had liposuction, abdominoplasty, or similar procedure over the past year or is
             planning to have such a procedure during the study.