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ARD-101 for Prader-Willi Syndrome
Phase 2
Recruiting
Research Sponsored by Aardvark Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of ketoacidosis or hyperosmolar coma
PWS due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect, confirmed by fluorescent in situ hybridization, chromosomal microarray, and/or methylation studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 15, day 28
Awards & highlights
Study Summary
This trial is testing a new drug to treat Prader-Willi Syndrome, a rare genetic disorder that causes intellectual disability, behavior problems, and obesity. The trial will assess the safety and efficacy of the drug in patients with the syndrome.
Who is the study for?
This trial is for individuals aged 17-65 with Prader-Willi Syndrome, a stable body weight, and no history of severe mental health issues or substance abuse. Participants must not be on insulin but can use certain other diabetes medications if doses have been stable. They should not have significant organ disease or recent medical treatments that could affect the study.Check my eligibility
What is being tested?
The trial is testing ARD-101, an oral medication for Prader-Willi Syndrome. It's a Phase 2 study where all participants receive the drug to see how safe it is and how well it works (since there's no comparison group).See study design
What are the potential side effects?
While specific side effects are not listed here, common concerns in trials like this may include digestive discomfort, potential blood sugar changes, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had ketoacidosis or hyperosmolar coma.
Select...
My PWS is confirmed by specific genetic tests.
Select...
I am between 17 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 15, day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 15, day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (TEAE)
Secondary outcome measures
Effect on Weight
Efficacy Evaluation of Hyperphagia in Prader-Willi Syndrome
Other outcome measures
Change in Body Fat
Change in GI Passage
Change in Patient Health
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ARD-101Experimental Treatment1 Intervention
First week 400 mg of ARD-101 twice daily, second week 600 mg of ARD-101 twice daily, third week 800 mg of ARD-101 twice daily, fourth week 800 mg of ARD-101 twice daily.
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
44 Total Patients Enrolled
Children's Hospital ColoradoOTHER
115 Previous Clinical Trials
5,127,597 Total Patients Enrolled
Stanford UniversityOTHER
2,389 Previous Clinical Trials
17,334,709 Total Patients Enrolled
1 Trials studying Prader-Willi Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was treated with ARD-101 and 3 months have passed since my last dose.Your blood sugar level when you haven't eaten is less than 140 mg/dL.You have had serious thoughts about hurting yourself or trying to end your own life.You have a high score on a specific test called HQ-CT.You have a PHQ-9 score of 10 or higher.My PWS is confirmed by specific genetic tests.I have not had any serious illnesses in the last 8 weeks.I have type 1 diabetes or another hormone-related condition but am on stable medication.You have had a problem with drinking too much alcohol in the past year, or you currently drink more than 21 drinks per week.You have had a very bad reaction or strong allergy to any medication.My kidney function is impaired, as shown by abnormal test results or a calculation.You weigh enough for your height.My HbA1c is below 7.5% and I'm not using insulin. If on GLP-1 drugs, I've been on a stable dose for over 3 months.My blood pressure and vital signs are stable.I agree to use two forms of birth control during and 90 days after the study.I am not able to have children due to surgery or being post-menopausal for over a year.I have a history of serious bleeding problems.I haven't used any weight loss products, including herbal ones, in the last 3 months.You have been diagnosed with certain mental health conditions that may make it hard for you to follow the study rules.I do not have any serious liver, kidney, lung, heart, cancer, or stomach/intestine diseases.You have lost a lot of blood or donated a lot of blood in the last 3 months.You drink more than 6 cups of caffeinated tea or coffee (or the same amount of other caffeinated drinks) per day.You have difficulty accessing veins.My medication doses have been stable for at least 30 days.My liver is not functioning properly, as shown by my test results.I have never had ketoacidosis or hyperosmolar coma.My heart's electrical activity is within normal ranges as per my last ECG.I am between 17 and 65 years old.Your blood test results and vital signs must be normal, or if not, the doctor and researchers must agree that it's not a big concern.
Research Study Groups:
This trial has the following groups:- Group 1: ARD-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being recruited for participation in this research?
"Indeed, according to the information posted on clinicaltrials.gov, this medical trial is currently accepting applications from eligible candidates. Having first been shared online on May 27th 2022, it has since seen an update on July 18th and aims to recruit 12 individuals at 2 different sites."
Answered by AI
What safety protocols are in place for the utilization of ARD-101?
"Our team at Power ranked ARD-101's safety as a 2 due to the limited evidence of efficacy from Phase 2 trials, but numerous studies affirming its security."
Answered by AI
Is the age criteria for this research confined to individuals under 45 years old?
"To meet the qualifications for this trial, individuals must be between 17 and 65 years of age. Furthermore, there are 376 clinical trials specifically designed to accommodate minors while 984 cater to patients past retirement age."
Answered by AI
Are there currently any openings for this clinical experiment?
"Affirmative. Clinicaltrials.gov shows that the recruitment phase of this clinical trial is currently ongoing, starting from May 27th 2022 and last edited on July 18th 2022. A dozen participants need to be enrolled across 2 different sites."
Answered by AI
For whom is this clinical trial an appropriate option?
"Qualified candidates must possess royer syndrome and be between 17 to 65 years of age in order to partake in this trial. 12 people are currently being recruited for the study."
Answered by AI
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