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NCT02796144 · ClinicalTrials.gov registry record · Phase 4
MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT02796144: Clinical Trial Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT02796144 is a Phase 4 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 71 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02796144, a Phase 4 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in patients with schizophrenia, a population for which no current weight-loss treatments have gained widespread use. The goal is to recruit overweight people with schizophrenia to participate in a 52-week double-blind, randomized study to assess the efficacy and safety of lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight, body composition, and measures of glucose and lipid metabolism. Participants: Approximately 110 subjects will be enrolled at four clinical sites (UNC Chapel Hill, Carolina Behavioral Care, Columbia University, and Augusta University) Procedures (methods): Behavioral: All participants will be offered a behavioral intervention of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This intervention will be provided at all in-person study visits after the Baseline Visit and supplemented with weekly interim phone calls to reinforce lessons between visits. Pharmacological Intervention: All participants who meet entry criteria will be randomized to one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).
Primary Outcome
Change in body weight in participants assigned to lorcaserin/metformin combination treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Lorcaserin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2016-09 |
| Est. Completion | 2020-02-14 |
| Phase | Phase 4 |
Why NCT02796144 stopped before completion
NCT02796144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02796144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02796144 about?
NCT02796144 is a clinical study titled "MEtformin and Lorcaserin for WeighT Loss in Schizophrenia". Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in patients with schizophrenia, a population for which no current weight-loss treatments have gained widespread use. The goal is to recruit overweight people with schizophrenia to participate in a 52-week doub...
What is the current status of trial NCT02796144?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2016-09. Estimated completion is 2020-02-14.
What interventions are being tested in trial NCT02796144?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lorcaserin (DRUG).
Who is sponsoring clinical trial NCT02796144?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02796144's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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