Clinical trial NCT05378503: Phase IV Study of Qsymia in Obese Patients
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Qsymia in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Obesity
Qsymia
Phentermine
Topiramate
Alvogen Korea
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 232
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight change rate(percent)
timeFrame: Week 56
Secondary outcomes:
measure: Weight change rate(percent)
timeFrame: weeks 14, 28, and 42
measure: The proportions(percent) of subjects whose body weight has changed
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in body weight
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in waist circumference
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in BMI
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in heart rate
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in blood pressure(Systolic and diastolic)
timeFrame: weeks 14, 28, 42, and 56
Other outcomes:
measure: The amounts of changes from the baseline in body composition (visceral fat area)
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in body composition (body fat percentage)
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in blood lipids (TC, TG, HDL-C, LDL-C)
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in diabetes indicators (HbA1c)
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in diabetes indicators (FBS)
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in diabetes indicators (Fasting Insulin)
timeFrame: weeks 14, 28, 42, and 56
measure: The amounts of changes from the baseline in diabetes indicators (HOMA-IR)
timeFrame: weeks 14, 28, 42, and 56
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee Univ. Hospital
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: KyungHee Univ. Hospital at Gangdong
state: Gangdong-gu
city: Bucheon-si
country: Korea, Republic of
facility: Sejong Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: The Catholic Univ. of Korea Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang Univ. Guri Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gil Hospital
state: Namdong-gu
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
state: Sacheon-myeon
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
affiliation: Hanyang Univ. Guri Hospital
name: ChangBeom Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: