Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Aardvark Therapeutics, Inc.
Updated on 3 December 2022
diabetes
body mass index
fasting
metformin
hemoglobin a1c
bariatric surgery
gastric bypass
gastric banding
sleeve gastrectomy

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).

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.

Details
Condition Bariatric Surgery, Obesity, Weight Gain
Treatment ARD-101
Clinical Study IdentifierNCT05215847
SponsorAardvark Therapeutics, Inc.
Last Modified on3 December 2022

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