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A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients
Bu çalışma, fazla kilolu ve obez hastalarda HSG4112 adlı ilacın güvenliliğini ve etkisini değerlendirmiştir. Çalışmaya, 19-70 yaş arasında, obezite düzeyinde ya da eşlik eden bir sağlık sorunuyla birlikte fazla kilolu olan hastalar alınmıştır. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.