Status and phase
Conditions
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About
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).
Full description
This is a Phase 2, open-label study to investigate the safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass). This study has a planned enrollment of 30 subjects (approximately 15 for each preceding surgical procedure) 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 (EOS 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.
Enrollment
Sex
Ages
Volunteers
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
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.
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 participants 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
Primary purpose
Allocation
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12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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