Health Adult Subjects, Obesity & Overweight
Conditions
Keywords
inhibitor of thioredoxin-interacting protein, TXNIP, TIX100, TIXiMED, Type 1 Diabetes
Brief summary
Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.
Interventions
DRUGTIX100
oral administration over 28 days
DRUGPlacebo
oral administration over 28 days
Sponsors
TIXiMED, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects aged 18-70 years, both genders. 2. Healthy as determined by the Investigator, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following: 1. Absence of clinically significant illness or surgery within the preceding 12 weeks. 2. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease. 3. Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study. 4. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use double-barrier contraception during the study. The primary contraception may be oral contraceptives, hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide. 5. Female subjects of non-child-bearing potential (i.e. bilateral tubal ligation (BTL), bilateral tubal occlusion (BTO), bilateral salpingectomy, hysterectomy, partial hysterectomy, bilateral oophorectomy, or postmenopausal, defined as no menses for 12 months without an alternative medical cause). 6. Body mass index (BMI) 25 - 34.9 kg/m2 7. HbA1c \<6.5% 8. Willingness to fully comply with protocol.
Exclusion criteria
1. History of excessive alcohol use (defined as \>21 drinks per week for males and \>14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen. 2. Pregnant or breastfeeding within six months of screening assessment. 3. Substantial changes in eating habits or exercise routines within the preceding three months. 4. Evidence of eating disorders. 5. \>5% weight change in the past three months. 6. Bariatric surgery within the past five years. 7. Significant renal impairment (eGFR \<60 mL/min/1.73m2). 8. Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements. 9. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression). 10. Use of prescription medications during screening and duration of the trial. 11. Use of drugs approved for the treatment of obesity. 12. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests. 13. A baseline prolongation of QT/QTcF interval after repeated measurements of \>450 ms for men and \>470 for women; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS. 14. Participation in an investigational drug trial within three months prior to dosing in the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Day 1 to Day 35 | * Number of subjects with Treatment-Emergent Adverse Events (TEAEs) * Number of subjects with clinically significant TEAEs (Physical Examination, Vital Signs, ECG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic: Area Under Concentration (AUC) | Day 1 and Day 28 | To determine the area under concentration (AUC) of multiple oral doses of TIX100 in otherwise healthy overweight/obese subjects |
Countries
United States
Contacts
CONTACTGloria Keopuhiwa
CONTACTMoises Hernandez
PRINCIPAL_INVESTIGATORAnath Shalev, MD
TIXiMED, Inc.
Outcome results
None listed