Clinical trial NCT01543269 (phase 1, status: terminated)
Conditions: obesity, lipid disorders
ICD codes: E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: zyt1, placebo tablets
SMILES: NC[C@H]1CC[C@@H](CC1)C(O)=O
Reason stopped: 
    safety concerns
  
Eligibility criteria:

        Inclusion Criteria:

          1. Age: 18-45 years

          2. Mentally, physically and legally eligible to give informed consent.

          3. Male and female volunteers weighing between 50-75kg and 45-75kg respectively.

          4. Ability to communicate effectively with the study personnel.

          5. Willingness to adhere to the protocol requirements.

          6. Normal Thyroid Function Tests (free and total T3, free and total T4 and TSH)

          7. Lipid criteria: Low density lipoprotein (LDL) cholesterol up to 160mg/dL and
             triglyceride (TG) level up to 500mg/dL

          8. For gender effect study, only females with history of sterility or one year menopause
             or use of long acting nonhormonal contraceptive measures (e.g., Intra uterine device)
             will be recruited.

        Exclusion Criteria:

          1. Presence or history of hypersensitivity to any of the active or inactive ingredients
             of ZYT1 formulation.

          2. History of thyroid disorders (any form) within 24 weeks prior to the recruitment in
             the study.

          3. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of
             normal (ULN).

          4. Renal insufficiency (serum creatinine > 1.5mg/dL).

          5. History of myocarditis, hypertrophic cardiomyopathy, valvular heart disease,
             restrictive cardiomyopathy, constrictive pericarditis, myocardial infarction, ischemic
             heart disease, stroke, congestive heart failure, cardiac arrhythmia or coronary
             revascularization procedure at any time.

          6. Subject who has corrected QT interval (QTc)³ 450 (male) or 470 (female).

          7. History or presence of musculoskeletal disorders (e.g., myopathies, myolysis,
             fractures due to osteoporosis, etc.)

          8. History or presence of other systemic disorders or diseases (e.g., respiratory,
             gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric
             disease or any other body system involvement).

          9. Subjects taking other hormonal therapies e.g., glucocorticoids, androgens or growth
             hormones.

         10. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation
             containing thyromimetic agents within 24 weeks prior to study entry.

         11. History of coagulopathy or use of anticoagulants such as warfarin.

         12. History or presence of chronic medications or any medications in the last 14 days.

         13. History or presence of significant alcoholism or drug abuse within the past one-year.

         14. History or presence of significant smoking (more than 10 cigarettes per day) or
             consumption of tobacco products (more than 10 times per day).

         15. Difficulty with donating blood.

         16. Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood
             pressure more than 90 mmHg and less than 60 mmHg.

         17. Pulse rate less than 60/minute and more than 100/minute.

         18. Any clinically significant abnormal X-ray or laboratory findings during screening.

         19. History or presence of any clinically significant ECG abnormalities during screening.

         20. Major illness and/or Major surgery in last 3 months.

         21. Volunteers who have participated in any drug research study other than the present
             trial within past 3 months.

         22. Volunteers who have donated one unit (350ml) of blood in the past 3 months.

         23. For gender effect study, female volunteers with following criteria will not be
             recruited:

               -  History of pregnancy or lactation in the past 3 months b- Fertile female
                  volunteers not protected against pregnancy by adequate long-term anti- fertility
                  device or history of less than one year of menopause

               -  Using hormonal contraceptives

               -  Using hormone replacement therapy

               -  Unable to give assurance for protection against pregnancy for 3 months after the
                  participation in this trial

               -  History of osteoporosis or history of fracture in the past 6 months

               -  Positive urine pregnancy test on the day of check-in.