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RECRUITING
NCT07008456
PHASE2

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

Sponsor: Aphaia Pharma US LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2025-09-12

Completion Date

2026-07

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

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

Locations (6)

LTD "Israeli-Georgian Medical Research Clinic Healthycore"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD "New Hospitals"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD "Acad. G. Chapidze Emergency Cardiology Center"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD "Diacor"

Tbilisi, K'alak'i T'bilisi, Georgia

NNLE "Jo Ann University Hospital"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD The First Medical Center

Tbilisi, K'alak'i T'bilisi, Georgia