drugset / Trial / 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

NCT07008456 ↗

Phase 2 Recruiting 102 enrolled Aphaia Pharma US LLC
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-09-12
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator APHD 002 Unknown 2 g —
Comparator APHD-012 Unknown 12 g —

Indications