Trials / Terminated
TerminatedNCT03338296
Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years
A 52 Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 278 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg) administered once daily (QD) as compared to placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lorcaserin hydrochloride XR | oral tablet |
| DRUG | Placebo | oral tablet |
Timeline
- Start date
- 2017-09-28
- Primary completion
- 2020-04-03
- Completion
- 2020-04-03
- First posted
- 2017-11-09
- Last updated
- 2021-07-19
- Results posted
- 2021-07-19
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03338296. Inclusion in this directory is not an endorsement.