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NCT02388568 · ClinicalTrials.gov registry record · NA
Lifestyle Modification and Lorcaserin for Weight Loss Maintenance
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 137
- Enrollment target
NCT02388568: Completed NA study, sponsored by University of Pennsylvania.
NCT02388568 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 137 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388568, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 137 participants
- Enrollment target
Study Summary
The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss achieved during a prior 14-week dietary run-in. 14-week run-in. To qualify for randomization, participants must lose ≥5% of initial weight in the 14-week dietary run-in. This loss will be achieved with the provision of weekly, group lifestyle counseling, which includes a 1000-1200 kcal/day portion-controlled diet that combines four daily servings of a liquid diet (HMR shakes) with an evening meal of a frozen-food entree (and a fruit and vegetable serving). More than 70% of participants are expected to achieve the 5% criterion loss during the 14-week run-in. A total of 182 women and men with a BMI ≥33 and ≤55 kg/m2, without co-morbidities, or ≥30 and ≤55 kg/m2 (with a co-morbid cardiovascular disease (CVD) condition) will be enrolled in the 4-month run-in period. Prior to enrollment, all participants will have a history, physical exam, electrocardiogram (EKG), and appropriate blood tests. They will attend weekly group sessions for 14 weeks. Participants will have a brief medical visit at week 8 to check their health and blood tests will be repeated. The investigators anticipate that 136 (75%) participants will lose 5% or more of initial weight and qualify for randomization. Participants who do not lose 5% will be provided a list of weight loss resources (e.g., other programs) to facilitate their continued weight management. 12-month randomized trial with lorcaserin. A total of 136 participants who have lost 5% or more of initial weight in the run-in period will be randomly assigned, in double-blind fashion, to lorcaserin (10 mg BID) or matching placebo. To be eligible, participants must have a BMI (after prior weight loss) ≥30 kg/m2 (without co-morbidities) or greater than or equal to ≥27 (with a co-morbidity). Randomization will be performed by the Investigational Drug Service at the Hospit
Interventions
- DRUG Placebo
- DRUG Lorcaserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02388568
The ClinicalTrials.gov registry entry for NCT02388568 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02388568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02388568 about?
NCT02388568 is a clinical study titled "Lifestyle Modification and Lorcaserin for Weight Loss Maintenance". The proposed 12-month randomized controlled trial will assess the efficacy of lifestyle counseling, combined with lorcaserin (10 mg BID) or placebo, in maintaining weight loss achieved during a prior 14-week dietary run-in. 14-week run-in. To qualify for randomization, participants must lose ≥5% of...
What is the current status of trial NCT02388568?
This trial is currently completed. It is a NA study. The enrollment target is 137 participants. The study started on 2015-01. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02388568?
The interventions under investigation include: Placebo (DRUG), Lorcaserin (DRUG).
Who is sponsoring clinical trial NCT02388568?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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