At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 177 enrolled
Drug / intervention
pramlintide acetate 360 mcg +4 moredrug
Likely dose
pramlintide acetate 360 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2A, Randomized, Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Effect on Body Weight of Recombinant-Methionyl Human Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
In Brief
A Phase 2 clinical trial evaluating pramlintide acetate 360 mcg, metreleptin, and 3 other interventions for Overweight and Obesity. Completed, enrolled 177 participants across 12 sites.
Detailed Summary
This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedOct 2006
Primary CompletionSep 2007
TodayJul 2026
First PostedOct 26, 2006
Enrollment StartOct 1, 2006
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.7 years ago
Interventions
pramlintide acetate 360 mcgdrug
subcutaneous injection, twice a day, 360mcg
metreleptindrug
subcutaneous injection, twice a day, 5mg
placebo-pramlintide 600 uLdrug
twice a day
placebo-metreleptin 1 mLdrug
twice a day
Pramlintide acetate 180 mcgdrug
subcutaneous injection twice a day, 180 mcg