ObesityPhase 4NCT05378503
Phase IV Study of Qsymia in Obese Patients
A Phase 4 study testing Qsymia 3.75Mg-23Mg Extended Release Capsule, Qsymia 7.5Mg-46Mg Extended Release Capsule and Qsymia 11.25Mg-69Mg Extended Release Capsule in people with Obesity, run by Alvogen Korea at 8 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Qsymia 3.75Mg-23Mg Extended Release Capsule, Qsymia 7.5Mg-46Mg Extended Release Capsule and Qsymia 11.25Mg-69Mg Extended Release Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 17 Sep 2021to 30 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
The Catholic Univ. of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
Sejong Hospital
Bucheon-si, Gyeonggi-do, 14754
GangNeung Asan Hospital
Gangneung, Sacheon-myeon, 25440
Hanyang Univ. Guri Hospital
Guri-si, Gyeonggi-do, 11923
Gil Hospital
Incheon, Namdong-gu, 21565
KyungHee Univ. Hospital
Seoul, Dongdaemun-gu, 02447
KyungHee Univ. Hospital at Gangdong
Seoul, Gangdong-gu, 05278
Severance Hospital
Seoul, Seodaemun-gu, 03722
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety 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.
- Conditions
- Obesity
- Being tested
- Qsymia 3.75Mg-23Mg Extended Release Capsule, Qsymia 7.5Mg-46Mg Extended Release Capsule, Qsymia 11.25Mg-69Mg Extended Release Capsule, Qsymia 15Mg-92Mg Extended Release Capsule, Placebo
- Keywords
- Obesity, Qsymia, Phentermine, Topiramate, Alvogen Korea
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qsymia 3.75Mg-23Mg Extended Release CapsuleDrug
Also called Low dose titration
From W0 to W2, once a daily.
Qsymia 7.5Mg-46Mg Extended Release CapsuleDrug
Also called Low dose maintenance
- 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 CapsuleDrug
Also called High dose titration
At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.
Qsymia 15Mg-92Mg Extended Release CapsuleDrug
Also called High dose maintenance
At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.
PlaceboDrug
From W0(Randomisation) to W56(the End of visit) once a daily.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change rate(percent)
Weight change rate(percent) from the baseline at week 56 after administration of the investigational product.
Measured: Week 56
Secondary outcomes (7)
Weight change rate(percent)
Weight change rate(percent) from the baseline at weeks 14, 28, and 42 after administration of the investigational product.
Measured: weeks 14, 28, and 42
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.
Measured: weeks 14, 28, 42, and 56
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
Measured: weeks 14, 28, 42, and 56
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
Measured: weeks 14, 28, 42, and 56
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
Measured: weeks 14, 28, 42, and 56
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
Measured: weeks 14, 28, 42, and 56
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
Measured: weeks 14, 28, 42, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start17 Sep 2021
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ChangBeom Lee, M.D., Ph.D., Principal investigator, Hanyang Univ. Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378503
- Sponsor's protocol ID
- 20-119
- Status last verified
- Jan 2024
- First submitted
- 10 May 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Qsymia in Obese Patients
- ClinicalTrials.gov ID
- NCT05378503
- Acronym / sponsor ID
- 20-119
- Conditions
- Obesity
- Keywords
- Obesity, Qsymia, Phentermine, Topiramate, Alvogen Korea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | 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 Capsule1. 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). |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of Qsymia placebo once a daily by the end of visit(W56). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qsymia 3.75Mg-23Mg Extended Release CapsuleAlso: Low dose titrationFrom W0 to W2, once a daily. | Drug | Active |
| Qsymia 7.5Mg-46Mg Extended Release CapsuleAlso: Low dose maintenance1. 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. | Drug | Active |
| Qsymia 11.25Mg-69Mg Extended Release CapsuleAlso: High dose titrationAt W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily. | Drug | Active |
| Qsymia 15Mg-92Mg Extended Release CapsuleAlso: High dose maintenanceAt W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily. | Drug | Active |
| PlaceboFrom W0(Randomisation) to W56(the End of visit) once a daily. | Drug | Placebo |
Primary outcome
Weight change rate(percent)
Time frame: Week 56
Weight change rate(percent) from the baseline at week 56 after administration of the investigational product.
7 secondary outcomes
Weight change rate(percent)
Time frame: weeks 14, 28, and 42
The proportions(percent) of subjects whose body weight has changed
Time frame: weeks 14, 28, 42, and 56
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 waist circumference
Time frame: weeks 14, 28, 42, and 56
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 heart rate
Time frame: weeks 14, 28, 42, and 56
The amounts of changes from the baseline in blood pressure(Systolic and diastolic)
Time frame: weeks 14, 28, 42, and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No. Confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChangBeom Lee, M.D., Ph.D. principal investigator
Hanyang Univ. Guri Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qsymia 3.75Mg-23Mg Extended Release Capsule, Qsymia 7.5Mg-46Mg Extended Release Capsule and Qsymia 11.25Mg-69Mg Extended Release Capsule in people with Obesity, run by Alvogen Korea at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change rate(percent) (time frame: Week 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.