NCT05803772

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• 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 participants with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)).

Detailed 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.

Conditions

• PreDiabetes
• Glucose Tolerance Impaired

Interventions

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

Timeline

• Start date: 2023-03-31
• Primary completion: 2024-02-12
• Completion: 2024-02-12
• First posted: 2023-04-07
• Last updated: 2024-10-16

Locations

3 sites across 1 country: Slovakia

Regulatory

• FDA-regulated drug study