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Completed

NCT Number: NCT05378503

Phase IV Study of Qsymia in Obese Patients

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.

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Key information

Conditions

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

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KyungHee Univ. Hospital, Seoul, Dongdaemun-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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)
  • Patients with severe heart failure (NYHA class III or higher), arrhythmia requiring treatment, and clinically significant heart valve disease
  • A history of anaphylaxis to active or minor ingredients of the investigational product
  • Hypersensitivity reaction or idiosyncrasy to sympathomimetic amine
  • 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)
  • Pregnant or lactating women
  • Those who disagree to the use of a medically acceptable contraception (see Section 14.1) during the study
  • A history of systemic steroid administration for 14 days or more within 3 months of screening visit
  • 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
  • Taking other appetite suppressants (including herbal medicines) excluding Qsymia (or drugs containing active ingredient of Qsymia) within 6 months prior to the screening visit
  • Participation in other clinical trials within 3 months before the screening visit (participation is based on the last administration date of the investigational product)
  • 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

Treatment and study plan

Qsymia 3.75Mg-23Mg Extended Release Capsule

Drug

From W0 to W2, once a daily.

Other names: Low dose titration

Qsymia 7.5Mg-46Mg Extended Release Capsule

Drug
  • 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.

Other names: Low dose maintenance

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.

Other names: High dose titration

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.

Other names: High dose maintenance

Placebo

Drug

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

Primary outcomes

  1. Weight change rate(percent)

    Time frame: Week 56

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

Secondary outcomes

  1. Weight change rate(percent)

    Time frame: weeks 14, 28, and 42

    Weight change rate(percent) from the baseline at weeks 14, 28, and 42 after administration of the investigational product.

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

    Time frame: weeks 14, 28, 42, and 56

    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.

  3. The amounts of changes from the baseline in body weight

    Time frame: weeks 14, 28, 42, and 56

    The amounts of changes from the baseline in body weight at weeks 14, 28, 42, and 56 after administration of the investigational product

  4. The amounts of changes from the baseline in waist circumference

    Time frame: weeks 14, 28, 42, and 56

    The amounts of changes from the baseline in waist circumference at weeks 14, 28, 42, and 56 after administration of the investigational product

  5. The amounts of changes from the baseline in BMI

    Time frame: weeks 14, 28, 42, and 56

    The amounts of changes from the baseline in BMI at weeks 14, 28, 42, and 56 after administration of the investigational product

  6. The amounts of changes from the baseline in heart rate

    Time frame: weeks 14, 28, 42, and 56

    The amounts of changes from the baseline in heart rate at weeks 14, 28, 42, and 56 after administration of the investigational product

  7. The amounts of changes from the baseline in blood pressure(Systolic and diastolic)

    Time frame: weeks 14, 28, 42, and 56

    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

Other outcomes

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

    Time frame: weeks 14, 28, 42, and 56

    (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

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

    Time frame: weeks 14, 28, 42, and 56

    (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

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

    Time frame: weeks 14, 28, 42, and 56

    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

  4. The amounts of changes from the baseline in diabetes indicators (HbA1c)

    Time frame: weeks 14, 28, 42, and 56

    The amounts of changes from the baseline in diabetes indicators (HbA1c) at weeks 14, 28, 42, and 56 after administration of the investigational product

  5. The amounts of changes from the baseline in diabetes indicators (FBS)

    Time frame: weeks 14, 28, 42, and 56

    The amounts of changes from the baseline in diabetes indicators (FBS) at weeks 14, 28, 42, and 56 after administration of the investigational product

  6. The amounts of changes from the baseline in diabetes indicators (Fasting Insulin)

    Time frame: weeks 14, 28, 42, and 56

    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

  7. The amounts of changes from the baseline in diabetes indicators (HOMA-IR)

    Time frame: weeks 14, 28, 42, and 56

    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

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 18, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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