Inclusion Criteria:

1. Must have completed all randomized treatment visits in the RCD (Shionogi protocol 0701A2823) or LCD (Shionogi protocol 0702A2824) study up to and including Visit 13.
2. Medically stable for 3 months prior to Visit 1 and in otherwise good health, with no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs.
3. Clinical laboratory evaluations (including clinical chemistry [fasted at least 8 hours], CBC, UA, including CPK, amylase, lipase, lipid profile, insulin, HOMA Index, HbA1c, TSH, Free T4, cortisol, iron, and ferritin) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
4. Males will be sterile or agree to use an approved method of contraception.
5. Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year since last menstrual period, surgically sterile for at least 3 months prior to Visit 1, or agree to use an approved method of contraception.
6. Able to understand and willing to sign an Informed Consent Form and comply with all study procedures.

Exclusion Criteria:

1. History or clinical manifestations of significant metabolic, hepatic, immunological (e.g., HIV/ AIDS), renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), urological, neurological or psychiatric disorders.
2. Current abnormal ECG, which, in the investigator's opinion, is clinically significant.
3. Current evidence of a psychological disorder, other than stable or controlled anxiety or depression including, but not limited to the schizophrenias. Treatment with an antidepressant or anxiolytic drug(s) will be permitted if the dose and form has remained stable for at least the previous three (3) months and the medication is not precluded/ excluded by this protocol because of potential effects on body weight and is not expected to change during the reminder of this clinical protocol.
4. A score above 10 in either the Anxiety or Depression portions of HADS at Visit 13/20.
5. Current obesity of endocrine origin.
6. Current Type 1 or Type 2 diabetes mellitus.
7. Current clinically significant hypertension, defined as blood pressure > 160/90 mm Hg for either the systolic or diastolic values in either the untreated or treated state.
8. Current or planned clinically significant GI surgery. NOTE: Appendectomy, and cholecystectomy will be allowed.
9. Current or planned gastric bypass surgery, stomach banding surgery, or any other surgical procedure(s) that attempt to promote/aid weight loss.
10. Current polycystic ovarian syndrome (PCOS).
11. Current or planned participation in any weight loss program outside of the program described in this OLE study.
12. Current alcoholism or drug addiction/ substance abuse within 1 year prior to Visit 1.
13. Current of any tobacco-containing or nicotine-containing product use within 1 year prior to Visit 1.
14. Current or planned participation in any other investigational study drug trial in which receipt of investigational study drug will occur.
15. Current or planned participation in any weight loss medication/product study in which receipt of weight loss medication/product will occur.
16. Current or planned use of any prescription or nonprescription OTC medication/ product or herbal/ phytotherapeutic/ plant-derived medications/ products that is intended to induce weight loss, appetite suppression, weight control or treat obesity.
17. Current or planned use of chronic medications/ products that are known to cause weight gain during the entire OLE study.
18. Current or planned use of any prescription or non-prescription OTC medications/ products, unless deemed acceptable by the Investigator.
19. Planned donation of blood or blood products during the entire OLE study.
20. Current poor peripheral venous access that would preclude blood collection.
21. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/ or participate in this clinical study.