A Phase 2, Placebo-Controlled, Randomized, Blinded Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ARD-101 in Adults With Obesity
Overview
- Phase
- Phase 2
- Intervention
- ARD-101
- Conditions
- Obesity
- Sponsor
- Aardvark Therapeutics, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Relative Change in Body Weight (%)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
ARD-101
Dose 200 mg of ARD-101, twice daily for 28 days
Intervention: ARD-101
Placebo Comparator
Placebo arm matching active arm ARD-101, 200 mg BID
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Incidence (Number) of Treatment-emergent Adverse Events (TEAE)(Days 1-28)
- Change in TC(Days 1 to 28)
- Change in TG(Days 1-28)
- Change in HDL(Days 1-28)
- Change in LDL(Days 1-28)
- Change in Waist Circumference(Days 1-28)
- Change in % HbA1C(Screening to Day 28)