NCT07008456

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

A Phase II Study to Investigate the Efficacy and Safety 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 APHP 002) Combined With a Gel Composition in Obese Subjects With Weight Related Comorbidities

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Aphaia Pharma US LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obese With Comorbidities
• Obese Patients (BMI ≥ 30 kg/m²)

Interventions

Type	Name	Description
DRUG	APHD-012	12 g dextrose beads
DRUG	APHD-002	2 g dextrose beads
DRUG	APHP-012	12 g placebo beads
DRUG	APHP-002	2 g placebo beads

Timeline

• Start date: 2025-09-12
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-06
• Last updated: 2025-09-16

Locations

6 sites across 1 country: Georgia