Phase IV Study of Qsymia in Obese Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

September 17, 2021

Primary Completion Date

October 30, 2023

Study Completion Date

October 30, 2023

Conditions
Obesity
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.

Trial Locations (8)

11923

Hanyang Univ. Guri Hospital, Guri-si

14647

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

14754

Sejong Hospital, Bucheon-si

21565

Gil Hospital, Incheon

25440

GangNeung Asan Hospital, Gangneung

02447

KyungHee Univ. Hospital, Seoul

05278

KyungHee Univ. Hospital at Gangdong, Seoul

03722

Severance Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alvogen Korea

INDUSTRY