Clinical Trial

A Study to Investigate the Efficacy and Safety of Two Different Doses of Twice Daily Distal Jejunal-release Dextrose Beads Formulations Combined With a Gel Composition Compared to Placebos in Obese Subjects With Weight Related Comorbidities

Recruiting Phase 2
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Record status
This record was last updated September 16, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this randomized, double-blind, placebo-controlled, phase IIa study is to demonstrate superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (APHD 012 and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (APHP 012 and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-05.
Status change: Not Yet Recruiting → Recruiting 2025-09-15
Trial Details
NCT Number NCT07008456
Lead Sponsor Aphaia Pharma US LLC
Conditions Obese With Comorbidities, Obese Patients (BMI ≥ 30 kg/m²)
Enrollment 102 participants
Start Date 2025-09-12
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-09-16