NCT07675590 · TIXiMED, Inc.
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
What this study is about
randomly assigned, compared against an inactive treatment Study to determine the safety and how well patients handle the treatment of multiple taken by mouth doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.
View original scientific description
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
DRUG
TIX100
oral administration over 28 days
DRUG
Placebo
oral administration over 28 days
Primary outcome measures
Safety and Tolerability
Time frame: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects aged 18-70 years, both genders.
- 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:
- Absence of clinically significant illness or surgery within the preceding 12 weeks.
- Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
- Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
- 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.
- 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).
- Body mass index (BMI) 25 - 34.9 kg/m2
- HbA1c \<6.5%
- Willingness to fully comply with protocol.
Exclusion criteria
- 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.
- Pregnant or breastfeeding within six months of screening assessment.
- Substantial changes in eating habits or exercise routines within the preceding three months.
- Evidence of eating disorders.
- \>5% weight change in the past three months.
- Bariatric surgery within the past five years.
- Significant renal impairment (eGFR \<60 mL/min/1.73m2).
- Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
- Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
- Use of prescription medications during screening and duration of the trial.
- Use of drugs approved for the treatment of obesity.
- Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
- 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.
- Participation in an investigational drug trial within three months prior to dosing in the present study.
Where
- Chula Vista, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations