Phase IV Study of Qsymia in Obese Patients

Alvogen

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Qsymia 15Mg-92Mg Extended Release Capsule; Drug: Qsymia 7.5Mg-46Mg Extended Release Capsule; Drug: Qsymia 11.25Mg-69Mg Extended Release Capsule; Drug: Placebo; Drug: Qsymia 3.75Mg-23Mg Extended Release Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05378503

20-119

Details and patient eligibility

About

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.

Enrollment: 232 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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232 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

1. Administration of Qsymia 3.75mg/23mg once a daily for 2-week(W2), and then administration of Qsymia 7.5mg/46mg once a daily for 12-week(W14). 2-1. At W14, if the weight loss rate is 3% or more, administration of Qsymia 7.5mg/46mg once a daily by the end of visit(W56). 2-2. At W14, if the weight loss rate is NOT 3% or more, administration of Qsymia 11.25mg/69mg once a daily for 2-week(W16), and then administration of Qsymia 15mg/92mg once a daily by the end of visit(W56).

Treatment:

Drug: Qsymia 7.5Mg-46Mg Extended Release Capsule

Drug: Qsymia 3.75Mg-23Mg Extended Release Capsule

Drug: Qsymia 11.25Mg-69Mg Extended Release Capsule

Drug: Qsymia 15Mg-92Mg Extended Release Capsule

Placebo

Placebo Comparator group

Description:

Administration of Qsymia placebo once a daily by the end of visit(W56).

Treatment:

Drug: Placebo