Actively Recruiting
Phase II Study of Two Doses of Twice Daily Distal Jejunal-Release Dextrose Beads With Gel vs Placebo in Adults with Obesity and Related Health Conditions
Led by Aphaia Pharma US LLC · Updated on 2025-09-16
102
Participants Needed
6
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different doses of distal jejunal-release dextrose beads combined with a gel composition on body weight reduction in obese adults with weight-related health issues. This phase IIa randomized, double-blind, placebo-controlled study aims to show whether these treatments provide better weight loss compared to placebo beads combined with the same gel composition. Participants will be assigned to one of four groups receiving either 12 g or 2 g of the active dextrose beads APHD-012 or APHD-002 or matching placebo beads APHP-012 or APHP-002. These treatments are taken twice daily. The study compares the effects of these doses over a 24-week period. During the study, participants will undergo assessments including body weight, blood pressure, blood lipid levels, fasting glucose, and HbA1c measurements at 24 weeks. Researchers will monitor safety and adherence throughout. The total participation lasts at least 24 weeks, during which weight and metabolic health are closely evaluated.
CONDITIONS
Brief Title
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
Research Team
S
Steffen S Bolz, Prof. (Univ. Toronto) Dr. med.
S
Susanne K Grafe, MD
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