Phase IV Study of Qsymia in Obese Patients

NCT05378503 | Completed Phase 4 FDA Drug

• 1 other identifier: 20-119
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 8

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.

Conditions

Obesity

Keywords

Obesity; Qsymia; Phentermine; Topiramate; Alvogen Korea

Outcome Measures

Primary Outcomes (1)

• Weight change rate(percent)

  Weight change rate(percent) from the baseline at week 56 after administration of the investigational product.

  Week 56

Secondary Outcomes (7)

• Weight change rate(percent)

  weeks 14, 28, and 42

• The proportions(percent) of subjects whose body weight has changed

  weeks 14, 28, 42, and 56

• The amounts of changes from the baseline in body weight

  weeks 14, 28, 42, and 56

• The amounts of changes from the baseline in waist circumference

  weeks 14, 28, 42, and 56

• The amounts of changes from the baseline in BMI

  weeks 14, 28, 42, and 56

Other Outcomes (7)

• The amounts of changes from the baseline in body composition (visceral fat area)

  weeks 14, 28, 42, and 56

• The amounts of changes from the baseline in body composition (body fat percentage)

  weeks 14, 28, 42, and 56

• The amounts of changes from the baseline in blood lipids (TC, TG, HDL-C, LDL-C)

  weeks 14, 28, 42, and 56

Study Arms (2)

Active

EXPERIMENTAL

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).

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Qsymia 3.75Mg-23Mg Extended Release Capsule DRUG

From W0 to W2, once a daily.

Also known as: Low dose titration

Active

Qsymia 7.5Mg-46Mg Extended Release Capsule DRUG

1. From W2 to W14, once a daily. 2. At W14, if the weight loss rate is 3% or more, from W14 to W56(the end of visit), once a daily.

Also known as: Low dose maintenance

Active

Qsymia 11.25Mg-69Mg Extended Release Capsule DRUG

At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.

Also known as: High dose titration

Active

Qsymia 15Mg-92Mg Extended Release Capsule DRUG

At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.

Also known as: High dose maintenance

Active

Placebo DRUG

From W0(Randomisation) to W56(the End of visit) once a daily.

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women aged 19 to 70 years
• Obese patients with BMI ≥ 25 kg/m2 at screening visit and visit 2
• Those who agreed to low-calorie regimen and exercise therapy during the study at screening visit
• From screening visit prior to randomization visit (Visit 2), low-calorie regimen and exercise therapy compliances are all ≥ 70%
• 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.
• Those who voluntarily decided to participate and gave written consent after being provided with and understanding the detailed explanation on this clinical trial

You may not qualify if:

• Patients with glaucoma
• 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)
• Arteriosclerosis patients with symptoms such as intermittent lameness and lower extremity pain
• 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.)
• Those who are taking monoamine oxidase (MAO) inhibitors at screening visit or who had taken less than 14 days before screening
• Patients with SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, or pulmonary hypertension at screening visit
• A history of eating disorders, drug or alcohol abuse
• A history of surgery for weight loss (e.g., bariatric surgery)
• A weight change of \> 5kg within 3 months prior to the screening visit
• A history of mental illness (e.g., bipolar disorder, depression, suicidal ideation, etc.)
• Obesity due to endocrine disorders or genetic obesity
• A history of kidney stones or gallbladder stones within 6 months of the screening visit
• 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.)
• Patients with renal impairment (CrCl \< 60 mL/min)
• Patients with hepatic impairment (AST, ALT ≥ 2.5 X ULN)

Sponsors & Collaborators

• Alvogen Korea: lead

Study Sites (8)

KyungHee Univ. Hospital

Seoul, Dongdaemun-gu, 02447, South Korea

Location

KyungHee Univ. Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

Location

The Catholic Univ. of Korea Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Sejong Hospital

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Hanyang Univ. Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Gil Hospital

Incheon, Namdong-gu, 21565, South Korea

Location

GangNeung Asan Hospital

Gangneung, Sacheon-myeon, 25440, South Korea

Location

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Obesity

Interventions

Qsymia; Maintenance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• ChangBeom Lee, M.D., Ph.D.

  Hanyang Univ. Guri Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: September 17, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)