At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 274 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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.
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin in Obese and Overweight Subjects
In Brief
A Phase 2 clinical trial evaluating Placebo and Pramlintide and Metreleptin for Obesity. Completed, enrolled 274 participants across 33 sites.
Detailed Summary
Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedJan 2009
Primary CompletionOct 2009
Study CompletionNov 2009
TodayJul 2026
First PostedJan 8, 2009
Enrollment StartNov 1, 2008
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.5 years ago
Interventions
Placebodrug
placebo pramlintide and placebo metreleptin twice daily
Pramlintide and Metreleptindrug
Subcutaneous injection, twice daily