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Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery

Obesity Clinical Trial

Official title:
A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of ARD-101 in Subjects At Least One Year After Bariatric Surgery

Clinical Trial Summary

The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).

Clinical Trial Description

This is a Phase 2, open-label study to investigate the safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass). This study has a planned enrollment of 30 subjects (approximately 15 for each preceding surgical procedure) 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 (EOS 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05215847
Study type Interventional
Source Aardvark Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 1, 2022
Completion date February 3, 2023
View Details
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