Phase IV Study of Qsymia in Obese Patients

Obesity Clinical Trial

Official title:

Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Qsymia in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05378503
• Other study ID #: 20-119
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Obesity

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