NCT05121441

Study to Evaluate ARD-101 in Adults With Obesity

A Phase 2, Placebo-Controlled, Randomized, Blinded Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ARD-101 in Adults With Obesity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Aardvark Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	ARD-101	Twice daily, oral administration
DRUG	Placebo	Twice daily, oral administration

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-11-09
• Completion: 2022-11-09
• First posted: 2021-11-16
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study