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

NCT05803772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-10-16

No results posted yet for this study

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)).

Conditions

Interventions

DRUG

APHD-012

Drug: APHD-012 Distal jejunal-release dextrose beads (Aphaia technology, AT)

DRUG

APH-012P

Distal jejunal-release placebo beads

Sponsors & Collaborators

  • Aphaia Pharma US LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-02-12
Completion
2024-02-12
FDA Drug
Yes

Countries

  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05803772 on ClinicalTrials.gov