A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
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.