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ACTIVE NOT RECRUITING
NCT05385978
PHASE2

A Study of Distal Jejunal-release Dextrose in Obese Participants

Sponsor: Aphaia Pharma US LLC

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose \[Aphaia technology, AT\]) in obese participants.

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose (Aphaia Technology, AT) in Obese Subjects

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2022-11-01

Completion Date

2024-11-11

Last Updated

2024-10-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

APHD-012

Distal jejunal-release dextrose beads (Aphaia technology, AT)

DRUG

APHD-012P

Distal jejunal-release placebo beads

Locations (9)

LTD "Israeli-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

LTD "Acad. G. Chapidze Emergency Cardiology Center"

Tbilisi, Georgia

LTD "Diacor"

Tbilisi, Georgia

LTD "National Institute of Endocrinology"

Tbilisi, Georgia

LTD "Tbilisi Heart Center"

Tbilisi, Georgia

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Universitätsklinikum Ruppin-Brandenburg

Neuruppin, Germany

GCM Medilcal Group

San Juan, Puerto Rico

FDI Clinical Research

San Juan, Puerto Rico