Study to Evaluate ARD-101 in Adults With Obesity

NCT05121441 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AARD-201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Anti-Obesity Agents; Body Weight

Outcome Measures

Primary Outcomes (1)

• Relative Change in Body Weight (%)

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

  Run-in Visit (baseline), Day 28

Secondary Outcomes (7)

• 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

Study Arms (2)

ARD-101

EXPERIMENTAL

Dose 200 mg of ARD-101, twice daily for 28 days

Drug: ARD-101

Placebo Comparator

PLACEBO COMPARATOR

Placebo arm matching active arm ARD-101, 200 mg BID

Drug: Placebo

Interventions

ARD-101 DRUG

Twice daily, oral administration

ARD-101

Placebo DRUG

Twice daily, oral administration

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aardvark Therapeutics, Inc.: lead
• University of California, San Diego: collaborator

Study Sites (1)

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

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Manasi Jaiman MD, MPH, Chief Medical Officer
• Organization: Aardvark Therapeutics, Inc.

MJaiman@aardvarktherapeutics.com

(858) 225-7696

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study includes two arms: one placebo arm and one intervention arm.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 16, 2021
• Study Start: November 15, 2021
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)