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Study to Evaluate ARD-101 in Adults With Obesity

Phase 2
Waitlist Available
Research Sponsored by Aardvark Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up run-in visit (baseline)

Summary

This trial is testing ARD-101, a medication taken regularly, in obese individuals with a BMI between 30 and 45. The drug works by interacting with taste receptors to help manage weight.

Eligible Conditions
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, days 1, 15, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, days 1, 15, and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Relative Change in Body Weight (%)
Secondary study objectives
Change in Blood Lipid Concentrations
Change in Hemoglobin A1c
Change in Waist Circumference
+1 more
Other study objectives
Area under the Curve (AUC) of Serum Levels of Glucose, Insulin, and C-peptide during MMTT
Body Fat Percentage
Categorical Weight Loss
+11 more

Side effects data

From 2023 Phase 2 trial • 12 Patients • NCT05215847
17%
Mild Nausea
8%
Mild Constipation
8%
Mild Headache
8%
Mild Heart Burn
8%
Mild Hypoglycemia
8%
Mild Dyspepsia
8%
Mild Common Cold
8%
Mild COVID-19
8%
Mild Emesis
100%
80%
60%
40%
20%
0%
Study treatment Arm
ARD-101

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARD-101Experimental Treatment1 Intervention
Dose 200 mg of ARD-101, twice daily for 28 days
Group II: Placebo ComparatorPlacebo Group1 Intervention
Placebo arm matching active arm ARD-101, 200 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARD-101
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Aardvark Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Obesity
12 Patients Enrolled for Obesity
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,688 Total Patients Enrolled
52 Trials studying Obesity
7,462 Patients Enrolled for Obesity
~5 spots leftby Dec 2025
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