Study to Evaluate ARD-101 in Adults Receiving Bariatric Surgery

NCT05215847 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AARD-202
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bariatric Surgery; Obesity; Weight Gain

Keywords

Obesity; Bariatric Surgery; Weight Gain; Anti-Obesity Agents

Outcome Measures

Primary Outcomes (1)

• Relative Change in Body Weight (%)

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

  Baseline and Day 28

Secondary Outcomes (4)

• Incidence of Treatment-emergent Adverse Events (TEAE)

  Days 1-28

• Change in Blood Lipid Concentrations

  Run-in Visit (baseline), Day 28

• Change in Waist Circumference

  Baseline and Day 28

• Change in Hemoglobin A1c

  Screening (baseline), Day 28

Other Outcomes (34)

• Categorical Weight Loss

  Run-in Visit (baseline), Day 28

• Circulating Levels of Glucagon-like Peptide (GLP)-1 (Pmol) During Mixed-Meal Tolerance Test (MMTT) at Baseline and on Day 28, and Prior to and Post Dosing on Day 1

  Run-in Visit (baseline), Day 1, Day 28

• Circulating Levels of Cholecystokinin (CCK) (pg/mL) During MMTT at Baseline and on Day 28, and Prior to and Post Dosing on Day 1

  Run-in Visit (baseline), Day 1, Day 28

Study Arms (1)

ARD-101

EXPERIMENTAL

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

Drug: ARD-101

Interventions

ARD-101 DRUG

Twice daily, oral administration

ARD-101

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
• 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
• 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):
• i. 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.

You may not qualify if:

• 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
• 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)

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; Weight Gain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

MJaiman@aardvarktherapeutics.com

(858) 225-7696

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study includes one intervention arm.

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 31, 2022
• Study Start: March 1, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 11, 2025
• Results First Posted: November 14, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)