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ObesityPhase 2NCT05121441

Study to Evaluate ARD-101 in Adults With Obesity

A Phase 2 study testing ARD-101 in people with 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
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Trial summary

The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in obese subjects with a body mass index (BMI) of 30-45 kg/m2. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity
What is being tested?
ARD-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
15 Nov 2021to 9 Nov 2022
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
  • BMI of 30-45 kg/m2
  • Stable body weight by subject report (± 5%) in the previous 6 months prior to randomization
  • No abnormal findings or abnormalities of clinical significance in vital signs, physical examination, clinical laboratory tests (complete blood count (CBC), urinalysis, blood biochemistry, coagulation, pregnancy test (females of child bearing potential), 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
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  • Standard 12-lead ECG parameters after 10 minutes 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 mmHg <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 they 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

  • History of significant drug hypersensitivity or anaphylaxis
  • Prior bariatric or GI surgery (excluding cholecystectomy, hysterectomy or appendectomy)
  • Participation in a weight loss program or clinical trial for weight loss within 30 days prior to randomization
  • Diabetes treatment (unless metformin as outlined), or chronic oral steroids, or treatment with immune modulators, anti-obesity drugs, chronic opiate therapy, or antipsychotic medications
  • Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to randomization
  • Currently receiving any drug-based therapy for weight management
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  • Thyroid-stimulating hormone (TSH) level is outside of normal limit
  • 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
  • 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.
  • Major surgery within 3 months prior to randomization or planned surgery during the study
  • Donated ≥200 mL of blood (blood components) or had massive blood loss, received blood transfusion or blood products within 3 months prior to randomization
  • Planned sperm/egg donation within 6 months post randomization
  • Positive urine drug test for any illicit non-prescription substances
  • 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 randomization
  • 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 randomization
  • History of human immunodeficiency virus antibody or active hepatitis
  • 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, Placebo-Controlled, Randomized, Blinded Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ARD-101 in Adults With Obesity

The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in obese subjects with a body mass index (BMI) of 30-45 kg/m2.

Read the detailed description

This is a Phase 2, randomized, placebo-controlled study to investigate the effects of ARD-101, a small molecule targeting bitter taste receptors (TAS2Rs), in obese subjects with a body mass index (BMI) of 30-45 kg/m2. This study has a planned enrollment of 30 subjects 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 (End-of-Study 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 in an outpatient setting and will be instructed to visit the clinical center periodically for safety and efficacy assessments.

Conditions
Obesity
Being tested
ARD-101, Placebo
Keywords
Obesity, Anti-Obesity Agents, Body Weight
Medical subject headings
Obesity, Body Weight

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

  • PlaceboDrug

    Twice daily, oral administration

Study groups in NCT05121441
Study groupRoleWhat they receive
ARD-101ExperimentalDose 200 mg of ARD-101, twice daily for 28 days
Receives: Drug: ARD-101
Placebo ComparatorPlacebo comparatorPlacebo arm matching active arm ARD-101, 200 mg BID
Receives: Drug: Placebo

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: Run-in Visit (baseline), Day 28

Secondary outcomes (7)

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

    The number of treatment-emergent adverse events (TEAE) reported by participants during the treatment period

    Measured: Days 1-28

  2. Change in TC

    The change in total cholesterol (TC) at the end of treatment from baseline

    Measured: Days 1 to 28

  3. Change in TG

    The change in triglyceride (TG) at the end of treatment from baseline

    Measured: Days 1-28

  4. Change in HDL

    The change in high density lipoprotein cholesterol (HDL) at the end of treatment from baseline

    Measured: Days 1-28

  5. Change in LDL

    The change in low-density lipoprotein cholesterol (LDL) at the end of treatment from baseline

    Measured: Days 1-28

  6. Change in Waist Circumference

    The change in waist circumference at the end of treatment from baseline

    Measured: Days 1-28

  7. Change in % HbA1C

    The change in % of hemoglobin A1c (HbA1c) at the end of treatment from baseline

    Measured: Screening to 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 posted16 Nov 2021
  2. Study start15 Nov 2021
  3. Primary completion9 Nov 2022
  4. Study completion9 Nov 2022

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
Randomised
Intervention model
Parallel groups
Model description
This study includes two arms: one placebo arm and one intervention arm.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121441
Sponsor's protocol ID
AARD-201
Status last verified
Jan 2025
First submitted
19 Oct 2021
Last updated
22 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zheng Z, Pettus JH, Warner A, Jones B, Pugsley M, Stege J, Hirakawa B, Jaiman M, Tolentino J, Lee TL, Kieffer TJ. ARD-101, a gut-restricted TAS2R agonist, reduces hunger in adults and promotes weight loss in DIO mice with DPP-4 inhibition. Mol Metab. 2026 Apr;106:102340. doi: 10.1016/j.molmet.2026.102340. Epub 2026 Mar 14.

    PubMed 41833222

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARD-101 in people with 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 15 inclusion and 23 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 22 Jan 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. Some participants in this study may receive a placebo. 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 22 Jan 2025). 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: Run-in Visit (baseline), 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 NCT05121441, which also lists 1 linked publication.

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 22 Jan 2025.

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