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Clinical Trial Summary

The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in obese subjects with a body mass index (BMI) of 30-45 kg/m2.


Clinical Trial Description

This is a Phase 2, randomized, placebo-controlled study to investigate the effects of ARD-101, a small molecule targeting bitter taste receptors (TAS2Rs), in obese subjects with a body mass index (BMI) of 30-45 kg/m2. This study has a planned enrollment of 30 subjects and will be conducted in a single center in the United States. The study will consist of a Screening Period (up to 28 days), a Treatment Period (28 days), and a Follow-up Period (End-of-Study Visit within 14 days after receiving the last dose of ARD-101). The screening procedures will be initiated upon completion of the informed consent process. Following completion of screening procedures and confirmation of eligibility, subjects will be enrolled to receive ARD-101 in an outpatient setting and will be instructed to visit the clinical center periodically for safety and efficacy assessments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05121441
Study type Interventional
Source Aardvark Therapeutics, Inc.
Contact Andreas Niethammer, MD, PhD
Phone 858-349-4820
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 12, 2021
Completion date September 2022

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