RecruitingPhase 2NCT07008456

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

Sponsor

Aphaia Pharma US LLC

Enrollment

102 participants

Start Date

Sep 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called APHD-002, a drug called APHD-012, and others for people with obese patients (bmi ≥ 30 kg/m²) and obese with comorbidities. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPHD-012

12 g dextrose beads

DRUGAPHD-002

2 g dextrose beads

DRUGAPHP-012

12 g placebo beads

DRUGAPHP-002

2 g placebo beads