| Eligibility |
Inclusion Criteria:
1. Able to comprehend and willing to sign an informed consent form approved by the IRB
before Screening.
2. 19 to 70 years, inclusive, at Screening.
3. BMI is 30 to 39.9 kg/m2, inclusive (obese), with or without comorbid conditions, or
BMI is 27 to 29.9 kg/m2, inclusive (overweight), with at least 1 documented treated or
untreated comorbid condition (e.g., hypertension, dyslipidemia, cardiovascular
disease, glucose intolerance, sleep apnea). All comorbid conditions must be considered
by the Investigator to be clinically stable.
? (BMI (kg/m2) = Weight (kg) / {Height (m)2})
4. Eligible females will be:
- females of childbearing potential who are not pregnant, evidenced by a negative
serum hCG pregnancy test at Screening
- non-lactating, or
- surgically sterile (defined as documented bilateral tubal ligation, bilateral
tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal (defined
as at least 12 months prior to Screening without menses with no alternative
explanation for the absence of menses).
5. Eligible males should have no plans to have children up to 90 days following the last
day of treatment.
6. A history of at least 1 unsuccessful weight loss attempt, per Investigator judgment.
Exclusion Criteria:
1. Clinically significant new illness, per Investigator judgment, in the 1 month before
Screening and during the screening period.
2. Significant history or clinical manifestation of allergic reaction or hypersensitivity
to the investigational product or any related drug compound.
3. Compliance with placebo self-administration is =80% during the 2-week single-blind
placebo run-in period.
4. Weight loss >3% during the 2-week single-blind placebo run-in period.
5. Diabetes mellitus (type 1, type 2, or other). A remote history of gestational diabetes
that has resolved is not exclusionary.
6. Previous or planned (for the duration of the study) bariatric surgery or device (i.e.,
gastric bypass, gastric banding, sleeve gastrectomy, gastric balloon, biliopancreatic
diversion)
7. Anticipated surgery during the study that may interfere with study completion or
compliance with the protocol.
8. Uncontrolled hypertension at Screening, defined as systolic blood pressure =160 mmHg
or diastolic blood pressure =100 mmHg. Subjects with uncontrolled hypertension at
Screening may be re-screened >3 months following initiation or adjustment of
antihypertensive therapy, if enrollment has not been closed.
9. Any of the following within 3 months of Screening: myocardial infarction, unstable
angina, cerebrovascular accident, transient ischemic attack, and cardiac arrhythmia
requiring medical or surgical treatment.
10. Evidence of any other unstable or untreated clinically significant hepatic, renal,
neurological, immunological, respiratory, endocrine, hematological, cardiovascular,
psychiatric, or neoplastic disease, or disease that, based on Investigator's judgment,
will make the subject inappropriate for the study.
11. Males with the following:
- history of, or known cause of hypogonadism (e.g., treatment for prostate cancer)
- history of infertility
- Klinefelter's syndrome or Kallmann's syndrome
- use of any medication within 6 months of Screening that can alter reproductive
hormone levels, either as the intended effect or as a side effect, including:
anabolic steroids, androstenedione, bicalutamide, cimetidine,
dehydroepiandrosterone, diethylstilbestrol, other estrogens, dutasteride,
finasteride, glucocorticoids (e.g., prednisone, cortisone, hydrocortisone, and
decadron), oral ketoconazole, megestrol acetate, opiates (e.g., morphine,
codeine, oxycodone, hydrocodone), spironolactone, testosterone or any androgen,
and any medications for treating prostate cancer.
12. Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction)
within 6 months of the Screening visit.
13. Congestive heart failure New York Heart Association class III and IV.
14. History of organ transplantation.
15. Screening TSH greater than 2x upper limit of normal. Subjects on L-thyroxine
replacement must be on a stable dose for at least 6 weeks prior to Screening.
16. Hyperthyroidism (screening laboratory value TSH <lower limit of normal) and/or
subjects taking methimazole, carbimazole, propylthiouracil, and/or beta-blockers for
hyperthyroidism.
17. Fasting triglycerides >500 mg/dL at Screening. Subjects with elevated triglycerides at
Screening may be re-screened >3 months after initiation or adjustment of
lipid-lowering treatment, if study enrollment has not been closed.
18. Screening glycosylated hemoglobin (HbA1c) =6.5%.
19. Fasting plasma glucose =126 mg/dL.
20. Clinically significant abnormal hepatic (e.g., AST or ALT greater than 2.5x ULN, or
total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome) or renal
function laboratory tests (e.g., glomerular filtration rate <60 mL/min).
21. Positive HBsAg, HCV Ab, HIV Ag/Ab, or VDRL at Screening.
22. Malignancy within 5 years of the Screening visit (except adequately treated cutaneous
basal cell or squamous cell carcinoma).
23. All chronic medications (including but not limited to: antihypertensives,
lipid-lowering drugs, cardiovascular drugs, antidepressants) must have been taken at a
stable dose (and dosing interval) for at least 3 months prior to Screening.
24. Treatment within 1 month of the Screening visit with over-the-counter weight loss
products or appetite suppressants (including herbal weight loss agents) or St. John's
Wort, or within 3 months with an approved anti-obesity drug.
25. Recent (within 6 months of Screening) participation in any organized weight loss
program (e.g., Juvis).
26. Treatment within 3 months of the Screening visit with systemic (i.e., oral or
intravenous) steroids for =7-day duration.
27. Recent history (i.e., within 2 years prior to the Screening visit) of alcohol or drug
abuse or a positive screen for drugs of abuse at Screening. Subjects with a positive
drug screen may be eligible with approval from the Sponsor if the subject has a
documented medical history requiring the need for chronic pain treatment and a
documented concomitant medication resulting in a positive drug screen, and provided
the subject is considered by the Investigator to be reliable to participate in the
study.
28. Significant change in smoking habits within 3 months prior to Screening, as judged by
the Investigator.
29. Participated in any other clinical study or bioequivalence study and was dosed with an
investigaiontal product within 6 months prior to the first day of dosing, unless there
is documentation that the subject received placebo.
30. Significant change in diet or level of physical activity within 1 month prior to
Screening, based on Investigator's judgment.
31. Weight loss or gain of more than 5% within 3 months prior to the Screening visit by
history or documented.
32. Unwilling, or whose partner is unwilling, to use a medically acceptable means of
contraception during and for 90 days following completion/withdrawal of the study.
? Medically acceptable contraceptive methods include:
- hormonal contraceptive
- intrauterine device that has been proven highly effective, used by the subject or
the subject's spouse/partner
- physical contraception (male or female) used with chemical sterilization
- surgical sterilization of the subject or the subject's partner (e.g., vasectomy,
hysterectomy, tubal ligation, salpingectomy).
33. Subjects who, in the opinion of the Investigator, should not participate in in this
study based on clinical laboratory test results or other reasons.
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