ARD-101 for Obesity

Altman Clinical and Translational Research Institute, University of California, San Diego, San Diego, CA
Obesity+2 More ConditionsARD-101 - Drug
Eligibility
18 - 75
All Sexes

Study Summary

This trial will test a new drug for people who had weight-loss surgery. The drug is taken twice daily, and the trial will evaluate how well it works and if it is safe.

Eligible Conditions
  • Post-Gastric Bypass Surgery
  • Obesity

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Reduction toward euinsulinemia (RE) protocol
1
Alpelisib treatment
1
Time restricted feeding

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Screening, Days 1, 15, and 28

Day 1, Day 28
Change in Indirect Calorimetry
Changes in Fecal Microbial Species and Their Relative Abundance
Days 1-28
Incidence of treatment-emergent adverse events (TEAE)
Run-in Visit (baseline)
Phenotypic Taste Test
Day 28
Circulating Levels of Adiponectin (mcg/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Amylin (pmol) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Cholecystokinin (CCK) (pg/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Ghrelin (pg/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Glucagon (pg/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Glucagon-like peptide (GLP)-1 (pmol) during Mixed-Meal Tolerance Test (MMTT) at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Glucose-dependent Insulinotropic Polypeptide (GIP) (pg/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Leptin (ng/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Circulating Levels of Peptide YY (PYY) (pg/mL) during MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1
Day 28
Area under the Curve (AUC) of Serum Level of C-peptide (ng/mL) during MMTT
Area under the Curve (AUC) of Serum Level of Glucose (mg/dL) during MMTT
Area under the Curve (AUC) of Serum Level of Insulin (uIU/mL) during MMTT
Categorical Weight Loss
Change in Blood Lipid Concentrations
Change in Fasting Blood Glucose
Change in Hemoglobin A1c
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Change in Serum Bile Acids
Waist Circumference
Change in the Percentage of Liver Fat Content
Circulating Levels of C Reactive Protein (CRP) (mg/L) during MMTT
Circulating Levels of IL-10 (pg/mL) during MMTT
Circulating Levels of IL-12 p40 (pg/mL) during MMTT
Circulating Levels of IL-12 p70 (pg/mL) during MMTT
Circulating Levels of IL-17 (pg/mL) during MMTT
Circulating Levels of IL-6 (pg/mL) during MMTT
Circulating Levels of Interleukin (IL)-1 beta (pg/mL) during MMTT
Circulating Levels of Tumor Necrosis Factor (TNF)-alpha (pg/mL) during MMTT
Relative Change in Body Weight (%)
Serum Levels of C-peptide (ng/mL) during MMTT at Baseline and on Day 28
Serum Levels of Free Fatty Acids during MMTT at Baseline and on Day 28
Serum Levels of Glucose (mg/dL) during MMTT at Baseline and on Day 28
Serum Levels of Insulin (uIU/mL) during MMTT at Baseline and on Day 28
Day 1
Body Fat Percentage
Day 1
Control of Eating and Food Cravings

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Reduction toward euinsulinemia (RE) protocol
1
Alpelisib treatment
1
Time restricted feeding

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

ARD-101
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: ARD-101 · No Placebo Group · Phase 2

ARD-101
Drug
Experimental Group · 1 Intervention: ARD-101 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARD-101
2021
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: screening, days 1, 15, and 28

Who is running the clinical trial?

Aardvark Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Obesity
20 Patients Enrolled for Obesity
University of California, San DiegoOTHER
1,051 Previous Clinical Trials
1,827,395 Total Patients Enrolled
52 Trials studying Obesity
7,545 Patients Enrolled for Obesity

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body mass index (BMI) falls between 35 and 60 kg/m2 during the screening period.
References

Frequently Asked Questions

Is the application window for this trial still available?

"Affirmative. According to the information displayed on clinicaltrials.gov, this medical trial is actively seeking participants and has been since March 1st 2022. The last update was made October 18th of that same year and so far 30 people have enrolled from a single site." - Anonymous Online Contributor

Unverified Answer

Does the demographic of 65+ apply to this research investigation?

"This medical study has established an age limit between 18 and 75 years old for participants, as specified in the inclusion criteria." - Anonymous Online Contributor

Unverified Answer

What are the criteria to be a participant in this research trial?

"This trial is currently recruiting 30 individuals with a BMI between 35-60 kg/m2 and ages ranging from 18 to 75. To be eligible, one must meet the following criteria: Male or female subjects aged 18-75 years old; they have undergone sleeve gastrectomy surgery at least 12 months ago and regained 20% of their nadir weight loss (defined as maximum preoperative weight - weight corresponding to a BMI of 25 kg/m2); serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and" - Anonymous Online Contributor

Unverified Answer

What is the total participant count for this experiment?

"Affirmative. Information on clinicaltrials.gov indicates that this research project is presently accepting enrolment, having been first posted on March 1st 2022 and most recently modified October 18th 2022. 30 individuals are sought after from a single site for the trial." - Anonymous Online Contributor

Unverified Answer

Has the U.S. Food and Drug Administration given their stamp of approval for ARD-101?

"Our analysts at Power assigned ARD-101 a score of 2 on the safety scale as it is currently in its second trial phase, meaning there are some data backing up security but no evidence confirming efficacy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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