A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Is obese with a BMI ≥35 to ≤45 kg/m2.
- Has stable body weight (not varying by >5% within 3 months prior to study start).
- Meets certain requirements with respect to concomitant medications.
- Has not smoked or used nicotine-containing products for at least 12 months prior to study start.
Exclusion criteria
- Has not been enrolled in a weight loss program within 2 months prior to study start.
Trial design
Primary purpose
Allocation
Interventional model
Masking
213 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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