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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05378503
Other study ID # 20-119
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 17, 2021
Est. completion date October 30, 2023

Study information

Verified date January 2024
Source Alvogen Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the weight loss effect and safety after administration of the test drug Qsymia in obese patients. To this end, the primary objective is to compare the weight change rate (%) between the study groups compared to the placebo groups at week 56 after administration of the investigational product. The secondary objective is to compare the weight change rate (%) at each evaluation point after administration of the investigational product, the proportions of subjects who lost more than 5% and more than 10% of weight at each evaluation point, and changes in weight/BMI/waist circumference/heart rate/blood pressure between the study groups compared to the placebo groups.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date October 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility Inclusion Criteria: 1. Adult men and women aged 19 to 70 years 2. Obese patients with BMI = 25 kg/m2 at screening visit and visit 2 3. Those who agreed to low-calorie regimen and exercise therapy during the study at screening visit 4. From screening visit prior to randomization visit (Visit 2), low-calorie regimen and exercise therapy compliances are all = 70% 5. From screening visit prior to randomization visit (Visit 2), those who fails to lose weight by at least 10% due to a low-calorie regimen and exercise therapy. 6. Those who voluntarily decided to participate and gave written consent after being provided with and understanding the detailed explanation on this clinical trial Exclusion Criteria: 1. Patients with glaucoma 2. Thyroid dysfunction (hyperthyroidism, hypothyroidism) (however, for hypothyroidism, the case of taking therapeutic agents stably at least 3 months prior to the screening visit is allowed) 3. Arteriosclerosis patients with symptoms such as intermittent lameness and lower extremity pain 4. Patients with type 1 diabetes or those with type 2 diabetes who are taking diabetic medications other than metformin. (However, metformin is allowed only if it was administered without dose change 1 month prior to screening visit.) 5. Those who are taking monoamine oxidase (MAO) inhibitors at screening visit or who had taken less than 14 days before screening 6. Patients with SBP = 160 mmHg, DBP = 100 mmHg, or pulmonary hypertension at screening visit 7. A history of eating disorders, drug or alcohol abuse 8. A history of surgery for weight loss (e.g., bariatric surgery) 9. A weight change of > 5kg within 3 months prior to the screening visit 10. A history of mental illness (e.g., bipolar disorder, depression, suicidal ideation, etc.) 11. Obesity due to endocrine disorders or genetic obesity 12. A history of kidney stones or gallbladder stones within 6 months of the screening visit 13. Patients who need to take furosemide (loop diuretic) or hydrochlorothiazide (thiazide-like diuretic) during the study (However, it is allowed only if it is administered for treatment of hypertension without dose change 3 months prior to screening visit.) 14. Patients with renal impairment (CrCl < 60 mL/min) 15. Patients with hepatic impairment (AST, ALT = 2.5 X ULN) 16. A history of treatment for transient ischemic attack (TIA), myocardial infarction, unstable angina, cerebral infarction, and cerebral hemorrhage, or angioplasty or coronary artery bypass grafting within 6 months prior to the screening visit (if it occurs before 6 months and is currently stable, it is possible to enroll) 17. Patients with severe heart failure (NYHA class III or higher), arrhythmia requiring treatment, and clinically significant heart valve disease 18. A history of anaphylaxis to active or minor ingredients of the investigational product 19. Hypersensitivity reaction or idiosyncrasy to sympathomimetic amine 20. A history of malignant tumor within 5 years prior to the screening visit (Surgery-resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia or thyroid cancer with no evidence of recurrence after 3 years of surgery are allowed) 21. Pregnant or lactating women 22. Those who disagree to the use of a medically acceptable contraception (see Section 14.1) during the study 23. A history of systemic steroid administration for 14 days or more within 3 months of screening visit 24. Within 3 months prior to the screening visit - Taking Qsymia or - Taking phentermine and topiramate in combination for weight loss or - Taking phentermine or topiramate for other purposes 25. Taking other appetite suppressants (including herbal medicines) excluding Qsymia (or drugs containing active ingredient of Qsymia) within 6 months prior to the screening visit 26. Participation in other clinical trials within 3 months before the screening visit (participation is based on the last administration date of the investigational product) 27. Other cases where the investigator determined that the subject is ineligible for participation in the obesity clinical study based on the history of medical or surgical disease or laboratory test results

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Qsymia 3.75Mg-23Mg Extended Release Capsule
From W0 to W2, once a daily.
Qsymia 7.5Mg-46Mg Extended Release Capsule
From W2 to W14, once a daily. At W14, if the weight loss rate is 3% or more, from W14 to W56(the end of visit), once a daily.
Qsymia 11.25Mg-69Mg Extended Release Capsule
At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.
Qsymia 15Mg-92Mg Extended Release Capsule
At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.
Placebo
From W0(Randomisation) to W56(the End of visit) once a daily.

Locations

Country Name City State
Korea, Republic of The Catholic Univ. of Korea Bucheon St. Mary's Hospital Bucheon Gyeonggi-do
Korea, Republic of Sejong Hospital Bucheon-si Gyeonggi-do
Korea, Republic of GangNeung Asan Hospital Gangneung Sacheon-myeon
Korea, Republic of Hanyang Univ. Guri Hospital Guri-si Gyeonggi-do
Korea, Republic of Gil Hospital Incheon Namdong-gu
Korea, Republic of KyungHee Univ. Hospital Seoul Dongdaemun-gu
Korea, Republic of KyungHee Univ. Hospital at Gangdong Seoul Gangdong-gu
Korea, Republic of Severance Hospital Seoul Seodaemun-gu

Sponsors (1)

Lead Sponsor Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other The amounts of changes from the baseline in body composition (visceral fat area) (Optional) The amounts of changes from the baseline in body composition (visceral fat area) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Other The amounts of changes from the baseline in body composition (body fat percentage) (Optional) The amounts of changes from the baseline in body composition (body fat percentage) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Other The amounts of changes from the baseline in blood lipids (TC, TG, HDL-C, LDL-C) The amounts of changes from the baseline in blood lipids (TC, TG, HDL-C, LDL-C) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Other The amounts of changes from the baseline in diabetes indicators (HbA1c) The amounts of changes from the baseline in diabetes indicators (HbA1c) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Other The amounts of changes from the baseline in diabetes indicators (FBS) The amounts of changes from the baseline in diabetes indicators (FBS) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Other The amounts of changes from the baseline in diabetes indicators (Fasting Insulin) The amounts of changes from the baseline in diabetes indicators (Fasting Insulin) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Other The amounts of changes from the baseline in diabetes indicators (HOMA-IR) The amounts of changes from the baseline in diabetes indicators (HOMA-IR) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Primary Weight change rate(percent) Weight change rate(percent) from the baseline at week 56 after administration of the investigational product. Week 56
Secondary Weight change rate(percent) Weight change rate(percent) from the baseline at weeks 14, 28, and 42 after administration of the investigational product. weeks 14, 28, and 42
Secondary The proportions(percent) of subjects whose body weight has changed The proportions(percent) of subjects whose body weight has changed by 5 percents or more and 10 percents or more at weeks 14, 28, 42, and 56 after administration of the investigational product. weeks 14, 28, 42, and 56
Secondary The amounts of changes from the baseline in body weight The amounts of changes from the baseline in body weight at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Secondary The amounts of changes from the baseline in waist circumference The amounts of changes from the baseline in waist circumference at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Secondary The amounts of changes from the baseline in BMI The amounts of changes from the baseline in BMI at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Secondary The amounts of changes from the baseline in heart rate The amounts of changes from the baseline in heart rate at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
Secondary The amounts of changes from the baseline in blood pressure(Systolic and diastolic) The amounts of changes from the baseline in blood pressure(Systolic and diastolic) at weeks 14, 28, 42, and 56 after administration of the investigational product weeks 14, 28, 42, and 56
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