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Study to Evaluate ARD-101 in Adults With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05121441
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Aardvark Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 19, 2021
First Posted Date  ICMJE November 16, 2021
Last Update Posted Date July 19, 2022
Actual Study Start Date  ICMJE December 6, 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2021)
Relative Change in Body Weight (%) [ Time Frame: Run-in Visit (baseline), Day 28 ]
The percent total weight change at the end of treatment from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2021)
  • Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: Days 1-28 ]
    The incidence of treatment-emergent adverse events (TEAE) during the treatment period
  • Change in Blood Lipid Concentrations [ Time Frame: Run-in Visit (baseline), Day 28 ]
    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
  • Change in Waist Circumference [ Time Frame: Run-in Visit (baseline), Day 28 ]
    The change in waist circumference at the end of treatment from the baseline
  • Change in Hemoglobin A1c [ Time Frame: Run-in Visit (baseline), Day 28 ]
    The change in hemoglobin A1c (HbA1c) at the end of treatment from the baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 4, 2021)
  • Categorical Weight Loss [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Proportion of subjects who lose < 5% and ≥ 5% initial weight
  • Circulating Levels of Gut Hormones and Other Factors by Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Circulating levels of glucagon-like peptide (GLP)-1 (total and active), cholecystokinin (CCK), peptide YY (PYY), amylin, glucose-dependent insulinotropic polypeptide (GIP) (total and active), ghrelin, leptin, adiponectin, and glucagon at the protocol-specified time points. Serum levels of glucose, insulin, and C-peptide prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for mixed-meal tolerance test (MMTT) is given at baseline (run-in visit) and on day 28.
  • Serum Level of Free Fatty Acids Included by MMTT [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Serum level of free fatty acids (FFA) prior to (negative timepoints) and post (positive timepoints) the Ensure meal given for MMTT is given at baseline (run-in visit) and on day 28
  • Circulating Cytokine Levels and Inflammatory Markers by MMTT [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Circulating levels of cytokines and inflammatory markers such as CRP at run in visit and end of treatment (day 28) performed during the MMTT
  • Body Fat Percentage [ Time Frame: Run-in Visit (baseline), Days 1-28 ]
    Body fat percentage measured by bioelectrical impedance scale
  • Change in the Percentage of Liver Fat Content [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Change in the percentage of liver fat content assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)
  • Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: Run-in Visit (baseline), Day 28 ]
    The change in homeostatic model assessment for insulin resistance (HOMA-IR) at the end of treatment from the baseline
  • Change in Fasting Blood Glucose [ Time Frame: Run-in Visit (baseline), Day 28 ]
    The change in fasting blood glucose at the end of treatment from the baseline
  • Change in Serum Bile Acids [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Change in serum bile acids at the end of treatment compared to the baseline
  • Phenotypic Taste Test [ Time Frame: Run-in Visit (baseline) ]
    Phenotypic taste test (using commercially available test strips) at baseline
  • Control of Eating and Food Cravings [ Time Frame: Screening, Days 1, 15, and 28 ]
    Control of eating and food craving assessed by the Control of Eating Questionnaire (CoEQ), which is a 21-item questionnaire designed to assess the intensity and type of food cravings and subjective sensations of appetite and mood according to an individual's experience over the last 7 days. Items on the CoEQ are assessed by 100-mm visual analogue scales [VAS]. Subjects will mark their level with a vertical line on the horizontal line of the VAS scale. The numerical value will start at 1.0 cm and end 10.0 cm. Use a ruler to determine the numerical value (to the tenth decimal) associated with the line marked by subjects. Higher score indicates less control of eating and food cravings.
  • Change in Indirect Calorimetry [ Time Frame: Day 1, Day 28 ]
    Change in indirect calorimetry between Day 1 and Day 28
  • Area under the Curve (AUC) of Serum Levels of Glucose, Insulin, and C-peptide during MMTT [ Time Frame: Run-in Visit (baseline), Day 28 ]
    Changes in AUC of serum levels of glucose, insulin, and C-peptide during MMTT between baseline and Day 28
  • Changes in Fecal Microbial Species and Their Relative Abundance [ Time Frame: Day 1, Day 28 ]
    Changes in fecal microbial species and their relative abundance assessed by 16S rRNA gene sequencing
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate ARD-101 in Adults With Obesity
Official Title  ICMJE A Phase 2, Placebo-Controlled, Randomized, Blinded Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ARD-101 in Adults With Obesity
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study includes two arms: one placebo arm and one intervention arm.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: ARD-101
    Twice daily, oral administration
  • Drug: Placebo
    Twice daily, oral administration
Study Arms  ICMJE
  • Experimental: ARD-101
    Dose 200 mg of ARD-101, twice daily for 28 days
    Intervention: Drug: ARD-101
  • Placebo Comparator: Placebo Comparator
    Placebo arm matching active arm ARD-101, 200 mg BID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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):

    i. 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andreas Niethammer, MD, PhD 858-349-4820 AndreasNiethammer@aardvarktherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05121441
Other Study ID Numbers  ICMJE AARD-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Aardvark Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aardvark Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of California, San Diego
Investigators  ICMJE Not Provided
PRS Account Aardvark Therapeutics, Inc.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP