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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
TIX100 40mg BID 		oral administration over 28 days
  • Drug: TIX100
    oral administration over 28 days
Active Comparator
TIX100 80mg BID 		oral administration over 28 days
  • Drug: TIX100
    oral administration over 28 days
Active Comparator
TIX100 120MG BID 		oral administration over 28 days
  • Drug: TIX100
    oral administration over 28 days
Placebo Comparator
Placebo 		oral administration over 28 days
  • Drug: Placebo
    oral administration over 28 days

Recruiting Locations

ProSciento, INC
Chula Vista, California 91911

More Details

Status
Recruiting
Sponsor
TIXiMED, Inc.

Study Contact

Gloria Keopuhiwa
619-799-4818
gloria.keopuhiwa@prosciento.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.