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

Recruiting Phase 2 Interventional Study
Obese With Comorbidities Obese Patients (BMI ≥ 30 kg/m²)
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
102 (estimated)
Sponsor
Aphaia Pharma US LLC · Industry
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About This Trial
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 composit…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and female subjects between an age of 18 (or the legal age of consent in the jurisdiction where the study is conducted) and 75 at the time of signing Informed Consent Form (ICF). 2\. Body Mass Index (BMI) of 1. ≥30 kg/m2 2. ≥27 kg/m2 and \<30 kg/m2 with at least 1 …
Contacts

Steffen S Bolz, Prof. (Univ. Toronto) Dr. med.

+41/41/78496331

bolz@aphaiapharma.com

CONTACT

Susanne K Grafe, MD

+41/41/78496331

grafe@aphaiapharma.com

CONTACT