(DBL-824) Weight Loss Study
(
Currently recruiting)
INTRODUCTION:
DBL-824 was developed for the purpose of non-stimulant based weight loss in those who are overweight. In addition to the previously demonstrated metabolic effects, DBL-824 appears to confer additional benefits.
PURPOSE:
The mechanisms of action and pharmacokinetics/dynamics of DBL-824 will be further examined.
The effect of DBL-824 administered to individuals of varying ages and exercise habits will be assessed, utilizing a retrospective cohort statistical analysis.
RATIONALE:
DBL-824 has demonstrated significant effect in Phase I, Phase II and Phase III clinical trials.
This observational study will obtain further data to complement the recently completed control studies.
STUDY TYPE AND DESIGN: Open Observational, Longitudinal, Retrospective Cohort Efficacy Study
OBJECTIVES: To determine continuing efficacy of DBL-824 in long-term administration, including maintenance phase.
INCLUSION CRITERIA:
Females and Males 18-68 years of age
No current serious medical issues
Not pregnant or nursing
Existing Overweight Condition (10 or more pounds & without upper limit)
EXCLUSION CRITERIA:
<18 years of age
>68 years of age
Current serious medical issue
Current pregnancy or nursing
NOTES:
Study is sponsored by Progenics, Inc.
Study is 24 months in duration.
Compensation is $319.73 per month. Requires completion of a brief questionnaire every month.
New enrollment will close without prior notice when target population is reached.
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