A Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation (APHD-012) in Subjects With a Pathological Oral Glucose Tolerance Test (OGTT)

PreDiabetes Clinical Trial

Official title: A Phase II, Randomized, Placebo - Controlled Crossover Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation (APHD-012) in Subjects With a Pathological Oral Glucose Tolerance Test (OGTT)

Status Recruiting

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 participants with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)).

Clinical Trial Description

The goal of this Phase II, Randomized, Placebo-Controlled Crossover Proof-of-Concept Study is to evaluate the efficacy of APHD-012 in patients with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)). The main questions it aims to answer are:

1. Are there changes in baseline in Area Under the Curve from Time 0 to 2 Hours (AUC0-2) values of Oral Glucose Tolerance Test (OGTT)?

2. Are there changes in biomarkers (e.g. fasting plasma glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR))?

Participants will receive study medication or placebo once daily for 6 weeks, followed by washout period of 4 weeks, and subsequent crossover to the other treatment arm for 6 weeks. ;

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose Tolerance Impaired
• PreDiabetes
• Prediabetic State

• NCT number: NCT05803772
• Study type: Interventional
• Source: Aphaia Pharma US LLC
• Contact: Abbie Liu, MSc
• Phone: 7872996563
• Email: liu@aphaiapharma.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2023
• Completion date: October 23, 2023