Orally Taken TIX100 in Healthy Overweight/Obese Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial randomizes healthy overweight or obese adults to receive either TIX100 or placebo for 28 days to assess safety and tolerability. It also studies how the drug behaves in the body (pharmacokinetics) after oral dosing. Participants undergo medical screening, daily dosing, safety monitoring, and laboratory tests. The study is sponsored by TIXiMED, Inc. with site involvement at ProSciento in Chula Vista, California.

Why it matters

Who can join: the full rules

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.

Where it's running

• ProSciento, INC
  Chula Vista, California, United States Recruiting

Study contacts

• Principal investigator: Anath Shalev, MD — TIXiMED, Inc.
• Study coordinator: Gloria Keopuhiwa
• Email: gloria.keopuhiwa@prosciento.com
• Phone: 619-799-4818

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.