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A Study of Distal Jejunal-release Dextrose in Obese Participants

Obese Clinical Trial

Official title:
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose (Aphaia Technology, AT) in Obese Subjects

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05385978
Study type Interventional
Source Aphaia Pharma US LLC
Contact Kai Deusch, MD
Phone +41 41 784 96 33
Email deusch@aphaiapharma.com
Status Recruiting
Phase Phase 2
Start date July 1, 2022
Completion date March 30, 2024
View Details
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