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Phase IV Study of Qsymia in Obese Patients

NCT05378503 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-01-31

No results posted yet for this study

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

Interventions

DRUG

Qsymia 3.75Mg-23Mg Extended Release Capsule

From W0 to W2, once a daily.

DRUG

Qsymia 7.5Mg-46Mg Extended Release Capsule

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.

DRUG

Qsymia 11.25Mg-69Mg Extended Release Capsule

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

DRUG

Qsymia 15Mg-92Mg Extended Release Capsule

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Alvogen Korea

    lead INDUSTRY

Principal Investigators

  • ChangBeom Lee, M.D., Ph.D. · Hanyang Univ. Guri Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378503 on ClinicalTrials.gov