Possibia

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.

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