NCT05215847

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (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 subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).

Detailed 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.

Conditions

• Bariatric Surgery
• Obesity
• Weight Gain

Interventions

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

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2022-01-31
• Last updated: 2025-02-11
• Results posted: 2024-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study