5385978
Last Update Posted: 2024-10-16
Recruiting has ended
All Genders accepted | 18 Years-70 Years |
150 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
A Study of Distal Jejunal-release Dextrose in Obese Participants
The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose \[Aphaia technology, AT\]) in obese participants.
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
Eligibility
Relevant conditions:
Obese
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Kai Deusch, MD
deusch@aphaiapharma.com
+41 41 784 96 33
Abbie Liu, MSc
liu@aphaiapharma.com
787-299-6563
Data sourced from ClinicalTrials.gov