AzTrials
AzTrials

Bariatric SurgeryPhase 2NCT05215847

Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery

A Phase 2 study testing ARD-101 in people with Bariatric Surgery and Obesity, run by Aardvark Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bariatric Surgery, Obesity, Weight Gain
What is being tested?
ARD-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Mar 2022to 3 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects, 18-75 years of age
  • Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
  • Body Mass Index (BMI) of 35-60 kg/m2 during the Screening Period
  • Status of at least 1-year post sleeve gastrectomy or gastric bypass surgery. Subjects must have a documented weight loss of at least 50% of their excess weight at their nadir, and must have regained at least 20% of their nadir weight loss. Excess weight is defined as maximum preoperative weight - weight corresponding to a BMI of 25 kg/m2
  • Subjects with rescue surgery (e.g. gastric band to sleeve gastrectomy or gastric bypass; sleeve gastrectomy to gastric bypass) will be allowed, with time since second surgery of at least 12 months.
  • Subjects with a history of revision procedures will be allowed if at least 6 months have passed since the procedure and weight has not deviated more than 5% in the 3 months prior to enrollment
Show all 17Show fewer
  • No abnormal findings or abnormalities of clinical significance in vital signs, physical examination, clinical laboratory tests (CBC, urinalysis, blood biochemistry, coagulation, pregnancy test (females), urine drug test, nicotine test, etc.), 12-lead electrocardiogram (ECG) during the Screening Period
  • Serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and total bilirubin (unless the subject has documented Gilbert syndrome) not exceeding 1.5-fold the upper laboratory norm and estimated Glomerular Filtration Rate (eGFR) >30 mL/min
  • Standard 12-lead ECG parameters after 10minutes resting in supine position in the following ranges; 120 ms <PR <220 ms, QRS <120 ms, QTc <= 430 ms if male, <= 450 ms if female and normal ECG tracing unless the Investigator considers an ECG abnormality within described limits to be not clinically relevant
  • Stable or well controlled blood pressure per Investigator's judgement during the Screening Period. Specifically: Vital signs after 10 minutes sitting in a chair (feet on floor, back supported):
  • 95 mmHg < systolic blood pressure (SBP) <160 mmHg, ii. 45 mm Hg < diastolic blood pressure (DBP) <100 mm Hg, iii. 40 bpm < heart rate (HR) <100 bpm.
  • Prediabetes- defined as a fasting blood glucose between 100-125 mg/dL OR an HbA1c between 5.7-6.5% at screening
  • Type 2 diabetes- Defined as previous diagnosis by a healthcare professional OR a fasting blood glucose > 126 mg/dL OR HbA1c > 6.5% at screening.
  • Patients with type 2 diabetes treated with metformin may be enrolled. However, patients with type 2 diabetes on any other therapy will be excluded.
  • Female subjects must have negative serum pregnancy test and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single barrier method (i.e., sponge), or a double-barrier method of birth control (i.e., condom with spermicide) or abstinence must be used/practiced throughout the study and for 90 days following last dose of study medication; for effective form of birth control.
  • Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusion) or post-menopausal for at least 12 months (may be confirmed with a screening follicle stimulating hormone (FSH) level in the post-menopausal lab range), do not require contraception during the study.
  • Males with female partners of childbearing potential must agree to a double-barrier method if participants become sexually active during the study and for 90 days following the last dose of the study medication. Male subjects must not donate sperm for 90 days following their participation in the study.

Who cannot join

  • Any relevant gastrointestinal (GI) surgery (excluding the gastric bypass or sleeve gastrectomy) per Investigator judgement
  • History of significant drug hypersensitivity or anaphylaxis
  • Participation in a weight loss program or clinical trial for weight loss within the 3 months prior to enrollment
  • Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to enrollment
  • Diabetes treatment (unless metformin as outlined), or chronic oral steroids, or treatment with immune modulators, anti-obesity drugs, chronic opiate therapy, or antipsychotic medications
  • Currently receiving any drug-based therapy for weight management
Show all 22Show fewer
  • Thyroid-stimulating hormone (TSH) level is outside of normal limit during the Screening Period
  • The presence of diseases with abnormal clinical manifestations that need to be excluded based on their possible contribution to weight loss or weight gain, including but not limited to nervous, cardiovascular, blood and lymphatic system, immune, renal, hepatic, gastrointestinal, respiratory, metabolic and skeletal diseases during the Screening Period
  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 6 months prior to Visit 1
  • Any malignancy not considered cured (except focal, treated basal cell carcinoma and squamous cell carcinoma of the skin); a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years
  • History of major depressive disorder or history of other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
  • Donated ≥200 mL of blood (blood components) or had massive blood loss, received blood transfusion or blood products within 3 months prior to enrollment
  • Planned sperm/egg donation within 6 months post enrollment
  • Positive urine drug test (morphine, methamphetamine, ketamine, ecstasy, and cannabis) during the Screening Period
  • History of consuming more than 14 units of alcoholic beverages per week or of alcoholism or drug/chemical/substance abuse within past 2 years prior to enrollment (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
  • Smoking any amount within 3 months prior to enrollment
  • Excessive consumption of tea, coffee, and/or caffeinated beverages (more than 8 cups, 250 mL for each cup) every day within 3 months prior to enrollment
  • Symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to enrollment
  • History of human immunodeficiency virus antibody, hepatitis C antibody or hepatitis B virus surface antigen
  • A history of psychiatric and psychological condition that, in the judgment of the investigator, may interfere with the planned treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications
  • Poor venous access or inability to tolerate venipuncture
  • Any condition or active drug treatment that the investigator or primary physician believes may not be appropriate for participating in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altman Clinical and Translational Research Institute, University of California, San Diego

    San Diego, California, 92037

Other trials in United States

About this study

Official title: 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

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).

Read the 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.

Being tested
ARD-101
Keywords
Obesity, Bariatric Surgery, Weight Gain, Anti-Obesity Agents
Medical subject headings
Obesity, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARD-101Drug

    Twice daily, oral administration

Study groups in NCT05215847
Study groupRoleWhat they receive
ARD-101ExperimentalDose 200 mg of ARD-101, twice daily for 28 days
Receives: Drug: ARD-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Change in Body Weight (%)

    The percent total weight change at the end of treatment from baseline

    Measured: Baseline and Day 28

Secondary outcomes (4)

  1. Incidence of Treatment-emergent Adverse Events (TEAE)

    The incidence of treatment-emergent adverse events (TEAE) during the treatment period

    Measured: Days 1-28

  2. Change in Blood Lipid Concentrations

    The change in blood lipid concentrations (total cholesterol, triglyceride, high density lipoprotein cholesterol, and low-density lipoprotein cholesterol) at the end of treatment from the baseline

    Measured: Run-in Visit (baseline), Day 28

  3. Change in Waist Circumference

    The change in waist circumference from baseline to end of treatment

    Measured: Baseline and Day 28

  4. Change in Hemoglobin A1c

    The change in glycated hemoglobin (HbA1c) at the end of treatment from the baseline

    Measured: Screening (baseline), Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start1 Mar 2022
  3. Primary completion3 Feb 2023
  4. Study completion3 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study includes one intervention arm.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215847
Sponsor's protocol ID
AARD-202
Status last verified
Oct 2024
First submitted
3 Jan 2022
Last updated
11 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARD-101 in people with Bariatric Surgery and Obesity, run by Aardvark Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change in Body Weight (%) (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in