A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects

NCT07675590 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TIX100-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Adult Subjects; Obesity & Overweight

Keywords

inhibitor of thioredoxin-interacting protein; TXNIP; TIX100; TIXiMED; Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  * Number of subjects with Treatment-Emergent Adverse Events (TEAEs) * Number of subjects with clinically significant TEAEs (Physical Examination, Vital Signs, ECG)

  Day 1 to Day 35

Secondary Outcomes (1)

• Pharmacokinetic: Area Under Concentration (AUC)

  Day 1 and Day 28

Study Arms (4)

TIX100 40mg BID

ACTIVE COMPARATOR

oral administration over 28 days

Drug: TIX100

TIX100 80mg BID

ACTIVE COMPARATOR

oral administration over 28 days

Drug: TIX100

TIX100 120MG BID

ACTIVE COMPARATOR

oral administration over 28 days

Drug: TIX100

Placebo

PLACEBO COMPARATOR

oral administration over 28 days

Drug: Placebo

Interventions

TIX100 DRUG

oral administration over 28 days

TIX100 120MG BID; TIX100 40mg BID; TIX100 80mg BID

Placebo DRUG

oral administration over 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TIXiMED, Inc.: lead

Study Sites (1)

ProSciento, INC

Chula Vista, California, 91911, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anath Shalev, MD

  TIXiMED, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Keopuhiwa

CONTACT

619-799-4818; gloria.keopuhiwa@prosciento.com

Moises Hernandez

CONTACT

619-845-3039; Moises.Hernandez@prosciento.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 30, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)