None listed
Conditions
Interventions
Drug : Group A (HSG4112 200 mg): 1 HSG4112 200 mg tablet + 2 placebo tablets, once-daily, 12-week multiple administration
Group B (HSG4112 400 mg): 2 HSG4112 200 mg tablets + 1 placebo tablet, once-da
Sponsors
Glaceum
Eligibility
Sex/Gender
All
Inclusion criteria
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 will have no plans for childbirth until 90 days after the last day of treatment. 6) A history of at least 1 unsuccessful weight loss attempt, per Investigator judgment.
Exclusion criteria
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 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 UL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight (kg) from Baseline to End of Treatment;Adverse event monitoring;Clinical laboratory test, vital signs, 12-lead electrocardiogram, physical examination;Male reproductive hormones (testosterone, luteinizing hormone, follicle stimulating hormone, sex hormone-binding globulin; males only) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects (%) with =5% body weight loss;Percentage of subjects (%) with =7% body weight loss;Percentage of subjects (%) with =10% body weight loss;Percent change (%) in body weight | — |
Countries
Korea, Republic of
Contacts
Public ContactSangsub Lee
Glaceum
Outcome results
None listed