Finding studies
Finding studies
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Lead
Aphaia Pharma US LLC
This is a randomized, double-blind, placebo-controlled, parallel-group, phase II proof-of-concept study to be conducted in 150 adult obese male and female participants who are 18 to 70 years of age with or without one or more endocrine and/or metabolic conditions. The study aims to evaluate the efficacy and safety of distal jejunal-release dextrose (Aphaia technology, AT) in obese participants. Participants will be randomly assigned to receive either APHD-012 (distal jejunal-release dextrose or APH-012P (a matching placebo). There will be two cohorts in the study. Participants from Cohort 1 will receive study medication once daily for 12 months (360 days), and participants from Cohort 2 will receive study medication once daily for 6 months (180 days). Overall, 150 participants will be enrolled in the study: * Cohort 1 (60 participants) - 6-month treatment period + 6-month maintenance treatment period * Cohort 2 (90 participants) - 6-month treatment period
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
