NCT05385978

A Study of Distal Jejunal-release Dextrose in Obese Participants

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Aphaia Pharma US LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Obese

Interventions

Type	Name	Description
DRUG	APHD-012	Distal jejunal-release dextrose beads (Aphaia technology, AT)
DRUG	APHD-012P	Distal jejunal-release placebo beads

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2022-05-23
• Last updated: 2024-10-16

Locations

9 sites across 3 countries: Georgia, Germany, Puerto Rico

Regulatory

• FDA-regulated drug study